L'-itea States :39Stic:C8s and
E";ifonmentai Protection TOXIC Subsrances
5n:orcemenr Division
5EFA Enforcement Facts
and Strategy
Premanufacture
Notification
(PMN)
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Premanufacture
Notification (PMN)
Contents Pa’e
PART ONE: REOLYIRINENTS AND GENERALS INFORMATION
Section 5: Premanufacture Totification 1— ]
Section 5 Enforcement Strategy Overview 1.— ]
Regulated Industries 1—2
Exemptions 1—3
Substances Excluded, from Section 5 RevLew 1—3
Reguirements of the Section 5 Program 1—4
Regulatory Options Under Section 5 1—4
Timetable 1—7
Interim Enforcement PoLicy 1—8
Enforcemenr 1—8
Objectives 1—8
Voluntary Compliance 1—8
Types of Violations 1—9
Bases for Targeting Lnspectioas 1—12
Violation Detection Methods 1—13
Remedies 1—14
PART TWO: OPERATIONAL CONSIDEL’ ,TIONS AND PRIORITIES
Priorities
Administrative Considerations 2—2
Allocation of Responsibilities 2—2
Program Integration 2—3
Enforcament Strategy August. 1 980
Section 5:
Premanufacture Notification
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PART TP.REZ: P OGRA 4 INPLEIENTATION MATERIALS
Section 5 Irtsnection Procedures 3— 1 .
Introduction 3—1
Section 5 VioLations List 3—3
Violation Specific Inspection Guidance 3—4
Section 5 Neutral Administrative Inspection Scheme 3—17
Interim Inspection Scheme 3—18
Discussion of Interim Scheme 3—20
Priorities and Resources 3—20
Discussion of Final Scheme 3—22
Evaluation of Targeting Criteria 3—22
Section 5 Penalty Policy Guidance 3—23
Introduction 3—23
Summary of the Policy 3—23
Detailed Back8round of the
Section 5 Penalty Policy 3—35
iforcament Strategy August. 1 980
Section 5:
Premanufacture Notification
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Part One
Requirements
and General Information
Contents Page
Section 5: Pre anufacture ot’ification 1—].
Section 5 Enforcement Strategy Overview 1—].
Regulated Industries 1—2
Exemptions 1—3
Substannes Excluded. from Section 5 Review 1—3
Requirements of the Section 5 Program 1—4
Regulatory Options under Section 5 1—4
TimetabLe 1—7
Interim Enforcement Policy 1—8
Enforcement 1—8
Objectives 1—8
Voluntary Compliance 1—8
Types of Violations 1—9.
Bases for Targeting Inspections 1—12
Violation Detection Methods 1—13
Remedies 1—14
Etiforcer,enr Strategy August, 1 980
Section 5:
Prnmanufacture Nodfication
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:3r C ia
I Requirements and General Information
Section 5: Premanufacture Totification
Section 5 of the Toxic Substances Control Act (rSCA) and the
Premanufacture Notification (PMN) regulacions proposed under
Section 5 of TSC 1 t require chemical manufacturers, processors,
importers, and exporters* Co notify EPA before manufacturing
processing, importing or exporting a new TSCA chemical (44 FR.
59764). The proposed regulations will allow EPA to take
regulatory action if any phase of the substance’s manufacture,
processing, distribution in commerce, use, or disposal. presents
an unreasonable risk to human health or the environment. -
A new TSC chemical is a substance that (1) does not appear in
the Inventory of Existing Chemical Substances published by EPA
under Section 8(b) of ISCA, (2) is not specifically excluded
from TSCA mandate (pesticides, firearms, ammunition, food, food
additives, drugs, cosmetics, devices, tobacco, tobacco
products, and specified nuclear materials are not covered by
TSCA), and (3) is not exempt or excluded from review under
Section 5.
The purpose of Section 5 of TSCA is to provide EPA with the
authority to quickly review and, if necessary, control new
substances Co prevent Large—scale distribution before the
substance’s effect on health or the environment is determined.
The Agency can control or, if necessary, ban a harmful
substance before ia4ust.r.ies become dependent upon both its
production and use. The Agency expects to receive from 200 to
400 Section 5 notices annuaLly.
Section 5 Enforcement Strace y Overview
Section 5 and the proposed PMN Regulations require chemical
manufacturers, processors, importers and emp’orters to notify
EPA prior to the manufacture, processing, importation or
exportat.ion. of a new TSCA substance. Section 5 then allows EPA
to take regulatory action if any phase of the substance’s
* TJhjle the interim policy for Section 5 does not require
exporters to submit Section 5 notices, the final ruLes will
probably require exporters to submit. these notices.
Enforcemer t Strategy 1_ I Auaust, 1 980
Section 5;
Premanufacture Notification
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Pan One I Requir men s and General Information
manufacture, processing) distribution in commerce, use, or
di sposal presents either an unreasonable risk to public health
or the environment or substantial or significant human
exposure. Together these notification and regulatory action
requirements prescribe the primary focus of OE’s enforcement
program, which is detection of “failure to notify” violations
and detection of noncompliance violations.
As the success of the premanufacture notification process is
vital to the overall effectiveness of TSCA, OE will, treat
Section 5 enforcement as a matter of the highest priority.
Both Eeadquarters and the Regions will work to detect
violations of the regulations and to take appropriate actions.
Regulated Industries
Manufacturers, processors, importers, and exporters are
directly subject to the PMN requirements, unless specifically
exempted. they must submit premanufacture notices when
manufacturing, processing, importing or exporting a new TSCA
substance. Commercial. users are indirectly subject to th PMN
requirements through the improper commercia). use provision of
Section 15. An EPA survey indicates that there are
approximately 10,000 chemical manufacturers. Of these firms,
150 have annual sales of over $100 million and account for 80
percent of industry sales. About two—thirds of chemical
manufacturing firms have, annual sales of less than $2.5
million.
While the figures for chemical processors are sketchy, current
estimates indicate that there are about 100,000 processors in
the united States.
There are no accurate figures available reg rding the number of
importers and exporters subject to the Sect’ion 5 requirements.
According to the American tmporters Association, there are at
Least 1,200 brokers and up to 5,00O importers that might be
affected. The United States Department of Commerce estimates
that 25,000 firms engage in exporting. Businesses that use
chemicals commercially are also subject to regulation under the
commercial use violation provision of Section 5.
EnTorcement Strategy 1—2 Auoust, 1 930
Section 5:
Pfemanufacture Notification
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1 Requuemei s an General lnformavon
Exe oc ions
EPA may, upon application, exempt from some or all of the PMU
requirements a manufacturer, processor, importer, or exporter
of any of the following:
• A new substance where the t est data is being
deveLoped by another establishment,
• A new substance that is being test marketed,
• A new substance that the Administrator determines by
rule to be not dangerous, or
• A substance that exists temporarily and will have no
environmental or human exposure.
In addition, an automatic exemption is granted for a person
manufacturing, processing, importing, or exporting a substance
in small quantities solely for research and development.
Substances Excluded from Section 5 Review
Sections 720.2 and 720.13 of the proposed Section 5 regulations
exclude several classes of substances from premanufacture
review:
• Mixtures,
• Coproducts,
• Impurities,
. Byproducts and
• Chemical substances that occur incidental to intended
production activities.
Enfcrc9rnern Strategy 1—3 August. 1 980
Sec:ion 5:
Premanu(acture Notification
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art One 1 ReQuirement3 and General Information
Requirements of the Section 5 Program
The proposed rules provide that notice can be accomplishe.d by
the submission of a completed Premanufacture 1ocice to the
Office of Pesticides and Toxic Substances (OPTS). Firms are
required to submit on this notice information known or
reasonably ascertainable concerning:
• Chemical identity
• Production quantities
• Uses
• Byproducts
• Health and environmental effects
• Exposure
• Methods of disposal
Regulatory Options Under Section 5
Zcer OPTS receives a Section 5 notice, it has, by statute, 90
days for review. (For good cause the review period can be
e cended an additional 90 days.) During the review perio4, EPA
may initiate actions under Section 5(e) or Section 5(f) to
regulate the chemical.
Section 5(e) . EPA is authorized under Section 5(e) to issue a
p:oposed order or apply directly to a U.S. District Court for
an injunction to prohibit or limit the manufacture, processing,
distribution in coerce, use, or disposal of a new chemical
substance. The agency may take action under Section 5(e) if:
• The information available is insufficient to permit a
reasoned evaluation of the health and environmental
effects of the chemical substance and either:
• The substance may present an unrea,soaable risk to
health or the environment, or
• There may be either substantial environmental
exposure, or substantiaL or significant human
exposure to the substance.
A proposed order must be issued prior to 45 days before the
expiration of the notice period. The affected firm has 30 days
from receipt of the proposed order to object to the order. If
no objections are made within the 30 days, the proposed order
Enforcemern Strategy 1—4 August. 1980
Section 5:
Premanufacture Notification
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jrt r.e 1 Reauirements arid Gener3l Iri(o,mat,an
becomes final and is enforceable once the ?? N review period
expires (usually about 15 days after this 30 day period). If
proper objections are filed, the Agency must obtain an
injunction in a U.S. District Court to regulate the substance.
The injunction will also not be effective until the PMN review
period has expired.
Section 5(f) . The Agency may take action under Section 5(f) i.E
it finds there is a reasonable basis to conclude that the
substance will present an unreasonable risk of injury to health
or the environment before a rule can be promulgated under
Section 6 to protect against the risk. EPA nay issue a
proposed order or apply directly to a U.S. District Court for
an injunction to prohibit the nanufacture, processing, or
distribution of the substance. (This is in contrast to Section
5(e) where the Agency nay take action when the •available
information is insufficient to permit a reasonable evaluation.
The purpose of the 5(e) action is to control the new substance
until enough test data is generated to allow the Agency to
reasonably evaluate the substance.)
A proposed order must be issued prior to 45 days before •th e
expiration of the notice period. The ‘affected firm has 30 days
from receipt of the proposed order to object to the order. If
no objecti.ons are made within the 30 days, the proposed order
becomes final and is enforceable once the PMN review period
expires (usually zbout 15 days after the 30 day period). If
objections are filed, the Agency must obtain an injunction in a
U.S. District Court to regulate the substance. The injunction
will also not be effective until the P!fN review period has
expired.
Alternatively, Section 5(f) authorizes EPA to issue a proposed
rule under Section 6(a) with any of the following
requirements:
• Limit the amou.nt of the substance’ which may be
manufactured, processed, or distributed in commerce,
• Prohibit or Limit the manufacture, processing, or
distribution in coerce of a chemical substance for
a particular use or for a particular use in excess of
a specified concentration,
• Require that. a substance be marked with use
instructions or warnings,
Enforcemen: S:;ateçy 1—5 August. 1980
Secvon 5:
Premanufacti.jre Notification
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One 1 Requirements and G nereI Information
• Require that the manufacturer monitor, keep records,
or conduct tests to assure compliance with any
requirement,
• Prohibit or limit any manner or method of commercial
use
• Prohibit or limit any manner or method of disposal.
Decision to Allow Production . Once the notification period
expires, the manufacturer, processor, importer, or exporter may
commence manufacture, processing, importation, or exportation
of the substance subject to any requirements EPA has issued
under Section 5(e) or Section 5(f). When manufacture,
processing, importation or manufacture for export begins, EPA
will, add the chemical substance to the tuventory in accordance
with Section. 8(b)(L) . Thereafter, any person may
manufacture,procass, or import the substance without giving EPA
notice. Other manufacturers, processors, importers, or
exporters who manufactur process, import, or export the same
substance are also subjec to any EPA requirements imposed upon
the original notice submipter.*
As premanufacture notification is not a certificatiob process,
lack of any regulatory action by EPA during the notif eation
period does not prevent EPA from regulating the chemical at a
future date. For certain chemicals, EPA may prefer to initiate
followup action rather than regulate the chemica]. during the
notification period. For example, the manufacture of a toxic
chemical which the manufacturer states has limited exposure may
not warrant immediate control action. Rowever, if future uses
or production changes increase exposure to the chemical, EPA
may under TSCA initiate two kinds of followup actions.
• EPA is authorized under Section 8(a) to require the
reporting of a wide variety oi inf,ormatioa. This can
be used to track a substance once’ it clears Section
5.
• Under Section 5(a)(2), EP A. may issue significant ew
use rules (SNUB s) which would require manufacturers
or processors to submit Section 5 notices if there
are significant changes in a substance’s use,
production volume, exposure, etc.
* tt is still unclear if EPA has the authority to impose these
restrictions on other firms, but the weight of analysis favors
the position stated in the text.
Enforcernem Strategy 1—6 August, 1 980
Section 5:
Premanufacture Notifcation
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‘art One
1 Requlremenc! and General Information
Other regulatory options available to EPA under TSCA after the
notification period expires are the use of Section 6 concerning
hazardous substances and Section 9 on the reLationship to other
Federal Laws. EPA would use Section 6 primarily in cases where
either:
• Additional data on a substance became available
indicating negative impacts on health or
environment,
• FoLlovup activities indicated serious changes in
exposure 1 or
• EPA was unable to regulate the substance under
Section 5 within the Section 5 review period.
Section 9 wouLd be used in cases where regulation of the
chemical could best be accomplished by another EPA office or
Federal agency (e.g., OSRA).
Timetable
An approximate timetable for implementation of Section 5 ii
given below. Testing guidelines and significant new use rules
(SNU s) will be developed during 1980—81. OE will amend the
enforcement strategy as these programs are developed.
Date
Proposal of Section 5
Rules and Forms.
Interim Policy
Publication of the Inventory
Effective Date of Section 5
Reproposal of Section 5 Forms,
and Sane Rules Provisions
Interim PoLicy — Revised
Final Section 5 Forms and Rules
Section 5 Testing Guidelines
Proposed
General Significant New se
Rules Proposed
January 10, 1979
May 15, 1979
June 1, 1979
July 1, 1979
(30 days after
I,nvertt ory
ub Lication)
October 16, 1979
Mid 1980
Late 1980
1980
1980
Enforcement Strategy
Secton 5:
Premanufactiare Notification
1—7
August. 1 980
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part One 1 Requirements and Gene,a Information
Interim Enforcement Policy
As indicated in the timetable, there will be several months of
Section 5 enforcement before the final Section 5 rules and
forms are issued.. TSCA states that the requirements of Section
5 become effective 30 days after pubLication of the Inventory.
This 30 day period expired on June 30, 1979. Despite the fact
the Section 5 regulations were not final at that time, the
Section 5 statutory requirements became effective JuLy 1, 1979.
Consequently, this period of tine between the effective date of
the statutory requirements and the effective date of the
regulatory requirements will have no effect on the Section 5
enforcement program.
Enforcement
Objectives
The objectives of this enforcement strategy are to ensure
that:
• Firms are submitting complete Section 5 notices for
new substances they intend to manufacture, process,
import, or export;
• Firms subject to Section 5(e) or Section 5(f) orders,
rules, and injunctions are complying; and
• Firms are complying with the terms of their
exemptions and PMN submissions.
Voluntary Com 1iance
because Agency enforcement resources are limited, the strategy
includes outreach programs to encourage both voluntary
compliance by industry and the reporting of violations by -
industry members, citizens, and workers. The Office of
Enforcement (OE) is currentLy developing these programs with
the cooperation of Office of Pesticides and Toxic Substances
(OPTS) and Office of PubLic Awareness (OPL). The programs
should be completed in F? 81.
The voluntary compliance portion of the outreach program will
furnish the information industry members need for understanding
TSCA requirements. This information will likely izic lude
interpretations and clarifications of specific. regulatory
Enforcement Strategy 1—8 Aucust 1 980
Section 5:
Premanufactug’e Notification
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:3rtC,e 1 Requirements nø C neraI Inio,mation
requirenents as well as detaiLed compliance information where
appropriate. While the outreach program will not restrain
those chemical producers who knowingly violate TSCA, it will
assist those industry members wishing to compLy to remain
within the law.
Tv,e€ of Violations -
Noncomoliance with a Section 5(e) or Section 5(f) Order. Rule.
or Injunction . Compliance with Section 5(e) or Section 5(f)
orders or rules is required by Section 15(l)(C) which prohibits
a firm from failing or refusing to comply with any Section 5 or
Section 6 order or rule. Those firms subject to court
injunction obtained under Section 5 are required by the nature
of the proceeding to comply.
Commercial Use of an tlle2ally Produced Substance . If a firm
knew, or had reason to know, that a chemical substance it used
for commercial purposes was manufactured, processed, or
distributed in commerce in violation of Section 5 or a Section
5 order, rule, or injunction, it has committed a commercial use
violation. Improper commercial use of a new substance is an
unlawful act under Section 15(2). (Note: OE will interpret
the term “use for commercial purposes” broadly to include any
use in manufacturing, processing, or distribution in commerce.
This interpretation is consistent with the legislative intent
of TSCA.)
Noncompliance with Test Marketing Exemution Restrictions . A
firm may seek an exemption from PMN under Section 5(h)(l) in
order to manufacture a new substance for test—marketing
purposes. Under this exemption, the Administrator may impose
restrictions on the te.st marketing of a substance (e.g.,
distribution limited to a three—state area). FaiLure to comply
with these restrictions constitutes a violation of Section
15(1)(B) which provides that noncompliance with a Section 5
requirement is unlawful. Some test marketin’g violations may
constitute a “failure to notify” violation. (See discussion of
that violation category on page 1—10.)
NonconDliance with Research and Develooment Exemotion
Restrictions . A firm may produce a new substance in small
quantities for the purpose of research and development* without
submitting the substance for PMN review under a Section 5
(h)(3) exemption. Under this exemption, the firm must not:
* OPTS will resolve at a later tine what the term “small
quantities for research and development” means.
Emorcernent Strategy 1—9 August, 1980
Section 5:
Premartufacture Notification
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Pati 0’e I Roquiremerns and General lnforma ian
• Produce more chemical than is needed for research and
development,
• Fail, to adequately warn those employees working with
the chemical if it or the Administrator knows or has
reason to know that the substance presents any risk
to health, and
• Use the research and development substance for
nonresearch and nondevetooment uses. (This is more
properly a “failure to notify” problem and is
discussed under that violation.)
Noncompliance with these requirements constitutes a violation
of Section l5(1)(3) which provides that noncompliance with a
Section 5 requirement is unlawful.
Withholdin2 Material Information from or Submission of
Materiall7 False or Misleading Information on a Section 5
Notice or Exemotion Reguest . The withholding of material
information from or the submission of materially false or
misleading information on either of these two notices
invalidates them. Not only- do these Section 5 notices or
exemption requests fai]. to satisfy the Section 5 requirements,
but their submission is prohibited by Section 15(l)(B) or
Section 15(3)(B). Should EPA decide not to regulate a
substance or approve an exemption as a result of the withheld
information or the false or misleading information, and the
firm making the submission commerciali:es the substance, the
firm would also be committing a “failure to notify” violation
because the PMN review or exemption approval was invalid. (See
discussion of failure to notify below.)
Failure to Notify . the failure by any firm described in
Section 720.10 of the proposed rules to provide a valid PMN
submission for any chemical described in Sec ,tion 720.12 of the
proposed rules constitutes a “failure to noEify” violation.
This action is prohibited both by Section 15(l)(B) of TSCA
which makes it. untawfui to faiL or refuse to comply with any
requirement prescribed by Section 5, and by Section L5(3)(3)
which makes it unlawful to fail or refuse to submit notices as
required’ by TSCA. The major variations of this violation
involve unidentified substances, substances identified by
lawful conduct, and substances identified by an associated
violation.
Er tcrcarnent Strategy 1—10 August, 1 980
Section 5:
Premanutacture Notification
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?3r rte I Requuement and General Informaciort
• Unidentified Substance . The first variation is that
a firm simply does not provide a Section 5 notice for
the substance in question. This variation also
includes those firms that could have avoi.ded the
Section 5 requirements by Legitimately placing their
substance on the tnventory, but who did not do so
either because of a simple error or because of a
deliberate attempt to circumvent TSCA. In either
case, OE could take action under authority of Section
8(b) and/or Section 5. (See Inventory Reporting
enforcement Strategy Document.)
• Substances Identified by Lawful Conduct . The second
major variation occurs when a firm commercializes a
new substance under one of the following conditions:
a requested exemption was denied, it never completed
its Section 5 Notice, or it. began production prior to
the expiration of the notice period.
• Substance Identified by Associated Section 5
Violation . The third major variation results from or
closely follows an associated substantive violation
of Section 5. The three substantive violations are:
withholding material information from or submission
of materially false or misleading information or a
Section 5 notice or exemption request, test marketing
violation, or research and development violation.
Withholding Material Information or Submission of
False or Misleading Information . The first type
results from. the withholding of material
information from or the submission of materially
false or misleading information. While this
constitutes a violation in itself, it also results
in rendering the entire Section 5 notice or
exemption request invalid. Thus any commercial
production and distribution of phe substance for a
nonexempt purpose constitutes a failure to notify
violation because the firm is essentially
producing the substance without notice, or
applicable exemptions.
Commercial Production of a Research and
Develo menc Substance . The second type results
from a research and. development violation.
Improper commercial production and/or distribution
of a. substance supposedly undergoing research and
development not only is a violation of the
research and deve]. pment exemption, but it is also
a failure to notify violation.
Er,forcercierct Strategy August. 1980
Section 5:
Premariufactuge Notification
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artCne - 1 R quIremanI5 and Gsneral Information
Production and Distribution in Excess of Test
Marketing Restrictions . The third type results
from the vioLation of a test marketing restriction
on production. Overproduction and distribution.
constitutes a failure to notify for the extra
amount produced. EPA could prosecute all these
overproduction situations as both test marketing
violations and failure to notify violations.
While the Agency viii al.vays prosecute the test
marketing violation, it viii only prosecute the
failure to notify violation when the permitted
production and distribution is exceeded by 100
percent or more.
3ases for Targeting tnspections
Ln order to obtain the most efficient use of Agency resources,
OS has developed a targeting scheme that focuses on likely
violators. The bases for this targeting is presented in Table
I on page 1—15.
Section 5 Notices . These notices viii be the basis of
targeting inspections for three different violations. OE will
focus on defective notices or notices which indicate a
significant level of projected production, importation, or
export a t ion.
Section 5(e) or 5(f) Orders, Rules, or Injunctions . Any firm
subject to a. Section. 5(e) or 5(f) order, rule, or injunction
will probably be inspected to determine if the firm is in
compliance with the applicable order, rule, or injunction.
Shi nin Records . These records will be the basis of targeting
inspections for improper conercial use violations. EPA will
examine the shipping records of those firms that have violated
Section 5 to determine which firms received the illegally
produced substances. The recipients will th n be inspected.
Exemption Recuests and AnDrovats . A. review of these requests
may indicate a potential violation and thus warrant an
inspection. At the same time, some of those substances subject
to approved exemptions n.a still concern the Agency, and
similarly warrant inspection. For example, if a test marketing
exemption is granted, but it- is not followed by a Section 5
notice at the end of the exemption period, the firm night be
coercializing the substance in violation of Section 5.
nfcrcemeru Strategy 1—12 August, 1 980
Section 8:
Premanufacture Notification
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I Requirements and General Information
Other Related Violations . In many cases, a firm will be
inspected for a “failure to notify” or an improper commercial
use violation because it has already violated a related portion
of Section 5. If for exampl.e, a firm violated Section 5 by
submitting a materially false or misleading statement in its
notice, it would be further inspected to determine if it
committed a “failure to notify” violation by commercializing
the substance.
Outreach . Active participation of labor, trade, and
environmental groups; private citizens; and industry members in
the reporting of TSCA violations could significantly enhance
the Agency’s enforcement efforts. Involvement in TSCA
enforcement will be enouraged by creating public awareness of
regulatory requirements and the enforcement process. The
Agency will, develop and distribute booklets and other
materials, encourage EPA participation in meetings, and sponsor
citizen action projects. In addition, EPA is currently
developing a: system for handling worker and citizen complaints.
Once completed, the program will be widely publicized.
Industry Characterization . OE is currently developing a
characterization of the industry based on Standard IndustriaL
Classification (SIC) codes. The purpose of this
characterization is to enable OE to determine which firms are
potential violators and then focus inspections on those firms.
As a further check in this characterization, Office of
Pesticides and Toxic Substances (OPTS) and OE will periodically
review new chemical patent applications at the Patent Office to
see if any chemicals are being developed without proper
notification. —
Violation Detection Methods
The primary detection methods for the discovery of major
Section 5 violations are listed in Table 1. ,The violation
detection program is tailored to meet the n eds of the Section
S enforcement program taking into account the number of
potentiaL violators, the difficulty of discovering a
violatiom, and the available compliance monitoring resources.
Plant tnsoections . The principal detection method wilt be
plant inspections. The inspections will reveal violations at
the establishment being inspected, and these violations will
often Lead. to the detection of violations in other firms. (For
example, the recipient of illegally produced substances may
commit a commercial use violation.) Inspectors will need to
examine pLant. records (production, shipping, storage, disposal,
E iforcement S ategy 1—13 August. 1 980
Section 5:
Premanufacture Notification
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Part On. I Requârcmerns and Genctai Information
etc.), and in some cases they may be required to take samples
or observe plant operation. to perform these inspections
effectively, inspectors will need special category confidential
business information authorization. (See Program
Implementation taceriaLs Section for a presentation of the
Section 5 inspection procedures.)
Subpoenas . The Agency may employ administrative subpoenas
issued under TSCA Section 11(c) instead of plant inspections in
situations where only a records inspection is necessary and the
use of a subpoena would be more cost effective than an on—site
inspection. Subpoenas may be particularly heLpftz L in followup
inspections of previous violators.
Inventory Cheeks . A firm that violates the requirement to
report a substance for the inventory may also violate Section 5
(failure to notify). Consequently 1 some Section 5 vioLations
vii]. be detected by EPA inventory inspections.
Remedies
After a violation has been discovered and any investigations
and inspections have been completed, OE must decermiae what
types of enforcem t action to take. The possibilities include
issuance of a notice of noncompliance, assessment of
administrative civil, penalties, and initiation of civil. or
criminal court actions.
Enforcement Strategy - August, 980
Section 5: 1
Premanufacture Notification
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Basis for Targeting
Tnc e jông
Prina ry
Detection
Methods
Nonconpliance with
Sec. 5(e), Sec. 5(f),
and Sec. 5(f)/See. 6(a)
Orders, Rules, or
Injunctions
Section 5 Notices,
Orders, Injunctions,
or Rules
Plant
Inspections,
Subpoenas
Commercial Use of an
Illegally Produced
Substance
Shipping Records of
Other Pir s that
VioLated Section 5
P1. ant
Inspections
Nonconpliaoce with
Test Marketing Ex p—
tion Restrictions
Exemption Request
and Approvals
Plant
Inspections,
Subpoenas
Noncompliance with R&D
Exemption Restricd.oas
Outreach
Plant.
Inspections
Withholding Material
Information or False
or Misleading
Information
Section Z Notices
or Exe pti.oo
a eque S t
P1 ant
Iaspection
Failure to Notify
Industry Charac-
terization, Outreach,
Notices, Exemption
Requests, Other
Related Vio].ations
Plant
Inspections,
Subpoenas,
Inventory
Checks
Enforcement Strategy
Section 5
Premariufacture Notific3tion
1—15
August. 1 980
Pert One i
Requi.emencs and General Information
TABLE 1 — Targeting Bases and Detection Methods
Violation
-------
Part Two
Operational Considerations
and Priorities
Contents Pa’e
Ptiorities 2—1
Ad injstrative Considerations z—z
Allocation of Responsibilities 2—2
PTogra Integration 2—3
Enforcemern SLrategy August. 1 980
Section 5:
Prernarwfacture Notification
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Pan Two 2 Op.iaiionai Consaderation m d Pnov’t ,es
Priorities
Because of the Agency’s limited resources,, it is important that
OE establish violation priorities for directing enforcement
efforts. For Section 5, the factors used for ranking
violations were the degree of potential risk (measured in terms
of toxicity and exposure) assocLated with the vioLation, and
the effect of the violation on the integrity of the TSCA
program. The following table gives the general priority
ranking for violations, this table is mean: only as a guide to
decision making and is not a rigid OE policy.
Priority Violation
I Noncompliance with Section 5(e) or
Section 5(f) orders, rules, or
injunctions
2 “Tailure to notify”
3 Vitholding material informatioi from
or submission of materially false or
misleading information on a Section
5 notice or exemption request
4 Noncompliance with test marketing
exemption restrictions
5 Noncompliance with a & D exemption
restrictions
Note : “Use for improper commercial purposes” violations
have the same priority as the underlying violations that
resulted in the commercial use violations. For example,
if a firm violated a test marketing re,s.triction, and the
Agency suspects that the recipient of the test marketed
substance committed a commercial use violation, the
priority for investigating this potential violation is the
same as for a test marketing violation, the associated
violation.
QE recognizes that as the Agency gains experience in
administering the Section 5 enforcement program, these
priorities may be modified to reflect that experience. U OE
determines that the prosecution of a high priority vioLation is
not significantly contributing to the enforcement effort, or if
OE feels that there is a high degree of compliance with the
associated requirement, then 0! will re—order the priorities.
Enforcement Strategy 2— 1. August; 1 980
Section 5:
Premanufaczure Notification
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3rI T wo 2 Operational Considerai ’or ’ iid Pno,;ties
Administrative Considerations
Allocation of Resooxisibilities
the primary role of Headquarters in the enforcement of Section
5 will be working with OPTS in revi.ewing notices, coordinating
the overall enforcement effort, and taking appropriate
regulatory actions. Since Headquarters will be the only place
where all PMN submissions will be reviewed, Headquarters will
be primarily responsible for targeting inspections and
providing technical information to execute those inspections.
The Regions will have the resoonsibility for performing
inspections and gathering evidence. The case preparation and
case litigation responsibilities will be evenly divided between
the Regions and Headquarters. The Regions will take three
categories of cases
• Noncompliance with a Section 5(e) or Section 5(f)
order, ruLe, or injunction,
• Commercial use of an illegally produced substance,
and
• Noncompliance with test marketing restrictions,
Headquarters will take the other three categories:
• Failure to notify,
• Withholding material information from or submission
of materially false or misleading information on a
Section 5 notice or ex ption request, and
• Noncompliance with research and development
restrictions.
(See Table 2 on page 2—4.)
The case preparation and litigation responsibilities are
divided this way in order to best utilize A ertcy resources.
The Regions will be responsible for the Sec’tion 5(e)15(f),
commercial use and test marketing violations because they
require minimal involvement from headquarters in developing the
cases. The Latter three categories are far more technical in
nature than the first three categories. Any case development
for these three violations will require a significant aount of
input from OPTS. Consequently, these latter three violations
were assigned to Headquarters.
While it is clear that the Regions are best suited to handle
the three categories of cases mentioned above, the shortage of
Regional resources in FY 80 and F! 81 will compel Headquarters
En orcsmenz Strategy 2—2 August. 1 980
Section 5:
Premanufacture Notification
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3t WO 2 O ra ionaI Cw s.derat;ons and Pr ,eruci
to e ither assist the Regions in case preparation and litigation
responsibilities or assume them if necessary. Over the first
two years of the program, Ueadquarters involvemeat in the
Regional case responsibilities will gradually evolve into an
advisory role. This will be accomplished by first reassigning
Headquarters attorneys to perform Section 5 enforcement work.
Then as the Regions assume their portion of the case
preparation and litigation repoasibilities, the involved
Headquarters attorneys vii ]. be reassigned back to their
intended functions. In any case, close cooperation between
Headquarters and the Regions, particularly in this interim
period, is vital to the success of the Section 5 enforcement
effort.
Program Integration
Through the compliance monitoring activities related to the
enforcement of Section 5, OE will obtain compliance monitoring
information involving other EPA enforcement programs. For
example, an inspector looking through a plant’s records on a
Section 5 enforcement investigation may turn up records
relating to other parts of TSCA , or, if a pesticide is
involved, the Federal Insecticide, Fungicide and Rodenticide
Act. In addition, an inspection for the discharge o.f chemical
wastes inco the environment may reveal violations of the water,
air or solid waste pollution control regulations. Thus, it is
inpottant for all those involved in Section 5 enforcement to
communicate non—Section 5 compLiance monitoring information to
the appropriate division of EPA.
At the same time, other EPA enforcement programs will be
obtaining compliance monitoring information relevant to the
Section 5 enforcement effort. This information will be
communicated to us by those EPA staff administering those
programs. This will be particularly so with Section 8(b)
Inventory inspections. A failure to report ,an eligible
substance for the inventory determination s’trongly suggests
that the nanufacturer in question has also committed a failure
to notify violation.
Enforcement St:ategy 2—3 August, 1 980
Section 5:
Prernanufacture Notification
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111111e 2
Ileatlquarteru and Regional Italea
Targeting
Cosiiliic tin g
l v1d nc
C g Piaaration
V*ulatioi InupecLion a
Li apectioiiu
Ca tli eriiig
. LiLigatiofl
Failure to IIQ lead Regiona lead Regiotia lead IIQ lead
Not iCy Regiona aupport IIQ aupport UQ aupport Kegtona aupport
Nooconipliance iiUi IIQ lead Regiona ei d Itegioiia lead Ilegiona lead*
ordera, mica, Regiona anpport IIQ aupport IIQ eupport IIQ aupport
and injunction
of Sec. 5( c),
Sec. 5(f) , end
Sec. 5(t)/Sec. 6(a)
WirhholdLng materiel IU) lead Regiona lead Regionu lead iiq lead
i afornia Lion froni Regiuni, auppor L auppurt UQ etiplior L Regiona auppor r
or bUI)Ifl1U ion of
[ alee or
leading informa—
Lion on Sec jon 5
notice or e einpLiou
reqilea L
Cosniiiercial uac IIQ lead Regiona lead Regiona lead Regiona lead*
of an illegally Regione aupport IIQ aupport IU) ulipport IIQ auppori.
produced aubatance
Noncompliance with IIQ eacl Ilegionu lead Ilegiona lead Regione leadk
It at marketiiig Regionii aupporI 11(1 eupport 11(1 uupporl. lit) aupport
rest r icc ions
Noncompliance with IIQ lead Regions lead Regions lead IIQ lead
it & 0 reatrictions Regions eupport Ut) support UQ support Kegiona support
*TIte ahoctage of Regional resources iii FY 80 and FY 81 will co,mipel headquarters to
eiLh r uaaist the Regions iii case preparation and litigation reajionaib Iities or asauune
Lhieae reapouisibilitiea it necessary.
2-
-------
Part Three
Program
Implementation Materials
Contents Pate
Section 5 Insoection Procedures 31
Introduction 3—1
Section 5 Violations List 3—3
Violation Specific Inspection Guidance 3—4
Section 5’Meutral Administrative tnsoection Scheme 3—17
Interim Inspection Scheme 3—18
Discussion of Interim Scheme 3—20
Priorities and Resources -
Discussion of Final Scheme 3—22
Evaluation of Targeting Criteria 3—22
Section 5 Penalt” Policy Guidance 3—23
Introduction 3—23
Summary of the Policy 3—23
Detailed Background of the
Section 5 Penalty Policy 3—35
Enforcement Strategy August, 1 980
Section 5:
Premanufacture Notiffcation
-------
tntroduction to Part Three
The program implementation materials are provided in three
separate documents. The first document, Section 5 tnspection
Procedures, provides general and violation specific inspection
guidance. The TSCA Base Manual, Volue 1 should be referred to
for genera ] . TSCA inspection information on pre—inspection
preparation, entry, opening conference, and closing conference.
The second document, Neutral Administrative Inspection Scheme
for Section 5, presents a plan for targeting Section 5
inspections consistent with the ttpreme Court’s decision.in
Marshall v. Barlow’s. tnc. . 4 . S . 307, 98 S. Ct. 1816
(1978). It will, guide both Kead ’iarters and the Regions in
se].ecting firms for inspections and vii]. serve as a supporting
document in a request for an administrative warrant for a
Section 5 inspection. The third document, Section 5 Penalty
Policy, adapts the general TSCA penalty policy to the, specific
needs of Section 5. The Section 5 Penalty Policy viii offer
guidance to R.egionai and Readquarters attorneys in assessing
penalties for violations. This document provides matrices for
measuring the degree of violation and a penalty assessment
example.
E- forcemer,t Strategy - August. .1.980
Section 5:
Premanufacture Notification
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P311 Three
3a
Section 5
Inspection Procedures
Introduction
! ns eceion Objectives
The objectives of Section 5 inspections are to:
• Determine if firms are submitting their new chemical
substances for Section 5 review;
• Determine if the firms subject to Section 5(e) or
Section 5(f) rules, orders, and i.njunctions are
complying with their terms;
• Determine i.f firms are complying with the terms of
their exemptions and Section 5 notices; and
• Determine the amount of substance involved in each
violation to facilitate penalty calculation.
General Preparation Considerations
• Pre—Insoection Prenaration . Depending upon the type
of inspection involved, the inspector will need to
obtain and review certain documents prior to
conducting an inspection.
Enforcement Strategy A gust. 1 980
Section 5: 3—1
Prernanufacture NotifTcation
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3a Sec iori S In o czion Procedures
The inspector should carefully consider what he viii
be trying to determine during the inspection and
where the relevant information or materiAl might be
located in the facility to be inspected. In
conjunction with this step, the inspector should
review the background of the targeted establishment
in terms of the kind of plant (by SIC code), its
production history, its violation history, and
inspectors’ comments from previous visits.
The inspector should prepare the necessary equipment
such as sampling apparatus, portable copier, camera,
and protective equipment. (See TSCA Inspection
Manual, Volume One, Chapter 3 for a detailed
discussion of pre—inspeccion preparation.)
Depending upon the type of inspection involved, the
inspector viii need to obtain and review certain
documents prior to conducting an inspection.
Verification Insoections . Inspections focu; d on
verifying statements in Section 5 notices o;
exemption requests viii require the inspectors to
become familiar with the statements to be
verified and the form which contains them.
Com liancs with Restrictions Insoectiorts .
Inspections focused on compliance with Section
5(e), Section 5(f), or exemption restrictions
will require th inspector to become familiar
with these documents. Reviev of Secton 5(e) and
Section 5(f) orders, rules, and injunctions or
Section 5 exemption restrictions will indicate to
the inspector what chemicals to Look for and what
restrictions, if any, have been imposed on the
chemical’s production. -
• Entry . See procedures presented in TSCA Inspection
Manual, Chapter 3, Section 2.
• Pre—tns ection Conference . Before beginning an
inspection, the inspector shoui .d discuss the focus of
the inspection during the opening conference with the
firm’s management representative. The inspector
shou Ld inquire as to how the firm’s records are
formatted and organized. This will save both the
firm. and the inspector a significant amount of time.
Next, the inspector and the management representative
should arrange a schedule for interviewing employees
_Er forcemeritStrategy August, 1980
Section 5: 3—2
Prernanufacture Notification
-------
rriree 3a Section 5 Inspection Procedures
relevant to the inspection, and for reviewing the
documents or plant processes in question. This will
allow the inspector to operate efficiently and keep
his interference with the plant’s operation at a
minimum.
As a final point,, the inspector should make an effort
to relieve any concern the management representative
might have about the inspection. It is particularLy
important to clarify questions about confidential
business information.
• Closing Conference . Upon completion of an.
inspection, the inspector shouLd meet with the
facility officials to wrap up the inspection. The
inspector should issue the necessary receipts, fill
in any gaps in his information, and again allay any
fears about the release of confidential. business
information. (See TSCL Base Manual for detailed
discussion at pages 3—61 to 3—63.)
Section 5 Violations List
• Noncomoliance with Section 5(e) and Section 5(f)
orders, rules, and injunctions
• Total production ban
• Restricted production, distribution, or use
• Commercial use of an ille allv oroduced s ibstance
• Noncomoliance with test marketing exemotion
restrict ions
• Production, distribution or use restriction
• aecardkeeping vioLation
. Noncomvliance with research and develonment exemotion
restrictions
. Overproduction
• Yailur to adequately warn employees
• Pailure to use substance for research and
development
Enforcement Strategy August. 980
Section 5
Premanufacture Notification
-------
P3rT Three 3a Section 5 InsOection Procedures
• Withholding material information from or submission
of materially false or misleading information on a
Section 5 notice or exemotion request
• Failure to noeif
• Unidentified new substance
• Substance identified by lawful conduct
• Substance identified by associated Section 5
violation
Withholding information from or submitting false
or misleading information
Noncompliance with test marketing restrictions
Noncompliance with the terms of a research and
development exemption.
Interrelated Violations . Although the Section 5 vioLation
categories and subcategories are distinct, several of them are
closely related. This is particularly so in the failure to
notify and commercial use violations. three variations of the
failure to notify violation will. result from. or closely follow
other substantive Section 5 violations. The three substantive
violations are ithhoLding material information from or
submission of materially false or misleading information n
Section 5 notice or exemption request, test marketing
violations, and research and development violations. For
discussion of these issues, see Substance Identified by
Associated Section 5 violation on pages 3—14 and 3—15 of this
guidance.
A similar interrelationship occurs between all the violation
categories and commercial use violations. 3y definition, a
commercial use violation does not occur unless there is a
preceding Section 5 vioLation. This issue is discussed under
the commercial use of an illegally produced substance guidance
on page 3-6.
Violation Specific Irisoection Guidance -
The following section presents guidance for conducting Section
5 iuspeeti.ons. Although there are only six main violation
categories, there are variations within each category. These
six violation categories aud their variations are discussed
below. The violations are not listed in order of priority.
(See Operational Considerations and Priorities Section for a
discussion of inspection priorities.)
Enforcement Strategy August, 1 980
Section 5:
Premanufacture Notification
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‘art Three 3a Section 5 nsgacnori Pvocedures
Nozicomoliance with Section 5(e) and Section 5(f) Orders. Rules. _
and Injunctions
There is a wide range of possible violations due to the Large
variety of possible orders, rules, and injunctions. The
objective of these inspections is to determine compliance with
the terms of these orders, rules, and injunctions. The
enforcement effort for this violation will focus on the firm
submitting the notice and any other firms that might be
producing the substance.* The procedures for these inspections
will, vary with the terms of the applicable order, rule, or
injunction.
• Total Production Ban . U one of these actions
imposes a total ban on production, the inspector will
need to know the trade name, generic name(s), and
chemical specific name of the substance in question.
This information will be sent to the Region prior to
the inspection. The inspector will look for the
particular chemical in the firm’s shipping,
production, or storage records. Should the inspector
find evidence of a violation, he should photocopy all
relevanc records and take a sample if possible.
• Restricted Production. Distribution, or l7se . In
those cases where a substance’s production,
d istribntion, or use is restricted , but not banned,
the inspector will check compliance with the
applicable restrictions. Consequently, the focus of
the inspection will depend upon the type of
restriction. The majority of these compliance
inspections will probably involve the review and
photocopying of disposal., shipping, storage,
production, and sales records. In those cases where
the Adminiscor has imposed efftueu,t or emission
limitations, the inspector will t eed to take
samples.
* It is still unclear if EPA has the authority to impose
these restrictions on other firms, but the weight of
analysis favors the position stated in the text.
- EnforcemeritSt;ategy August. 1980
Section 5: 3_ ,5
Premanufacture Notification
-------
?artTrree - 3a Section5In oeciion Procedures
Commercial use of an Illegally Produced Substance
If a firm knows or has reason to know that a substance it uses
for commerciaL purposes was manufactured, processed, or
distributed in commerce in violation of Section 5 or a Section
5 order, rule, or injunction 1 it has committed an improper
commercial use violation. GE vii ]. interpret “use for
commercial purposes” broadly to include any use in
manufacturing, processing, or distribution in commerce. Thus,
anytime an inspector finds a substantive violatioa of Section
5, ha or she should examine that firms shipping records to
determine what firma, i.E any, received the illegally produced
substance. The objective of inspecting for this type of
violation is to detect the presence of an illegally produced
substance, and then to obtain evidence indicating whether the
inspected firm knew or had reason to know that the substance
was produced in violation of Section 5.
• Presence of the Illegally Produced Substance . The
inspector should look for the presence of substances
produced in violation of Section 5 by examining
shipping records, purchase orders, and storage
records. For each fins selected for inspection,
Eeadquarters will provide a printout of all
substances that a firm has reported for the
Inventory, the CAS number of each substance (if
available), and the Inventory form number (if
available).
Review of Plant Records . The inspector will
first check the names of the substances in the
plant’s records against this Eeadquarters List.
If any substances are not on the list, the
inspector will check the substance(s) in question
against the Inventory itself, both the
confidential and nonconfidential parts of the
inventory. (The firm is required to furnish the
chemical specific name upon request.)*
* If a firm has placed the substance on the Inventory, the
Section 8(b) regulations require it to furnish the chemical
specific name upon request. Section 710.1(c) states: -
Each person who reports under these regulations shall
maintain records that document information reported under
these regulations and in accordance with the Act, permit
access to, and the copying of suc i records by EPA Officials
[ 4.2 FederaL Register 64,575 (1977)].
For those subscances that were not placed on the Inventory, an
inspector may still request the chemical specific name on the
basis of Sections 8(a) and 11(b).
- Enforcement Strategy August. 1 980
Section 5: - 3—6
Premariufacture Notification
-------
3fl re 3a Se:!c3n5 Inspection Procedures
Anal9sis of Records . If the substance is:
(1) not on the Inventory,
(2) commerci.ally used by the firm inspected,
(3) covered by TSC. (i.e., not a pesticide,
food, food additive, drug, cosmetic, device,
specified nuclear material, firearm,
ammunition, tobacco, •or tobacco product),
(4) covered by the Section 5 regulations (i.e.,
not a mixture, coproduct, impurity,
byproduct, or a chemicaL substance that
occurs incidental to intended production
activities),
(5) not covered by a Section 5 exemption,
then the establishment has met the first
requirement of using a substance that was
provided to that firm in vioLation of Sectioa 5•*
See proposed Section 5 regulations, Section
720.2, Section 720.13, Section 720.14, and
Section 720.15 (44 FederaL Register 2264—68
(January 10, 1979)1.
* Until the closing of the revised Inventory, processors nay.
process a substance for ISCA purposes that was not. reported for
the Inventory but was either manufactured for research and
development prior to July 1, 1979 or was manufactured at any
time for a. non—TSC& use.
_Eniorcerrient S ;ategy August. 1 980
Section 5:
Premanufacture Notification
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3n Three 3a Saciton S Inepection Procedures
Targeting Considerations . An inspector may be
directed to a certain establishment because it
was listed as a recipient of some illegally
produced chemicals in the shipping records of
another violator. In such cases, much of the
inspection work is simplified as the inspector is
Looking for a specific substance. Conversely, if
a commercial use violation is discovered without
the aid of previous violations, the inspector
should ex ine the violator’s records to
determine the source of the improperly produced
substance. If a source is discovered, it should
be inspected. As in the previous situation, the
inspector examining the suspected distributor is
looking for a specific substance.
• Knovledze of Violation . Should the inspector find
evidence that an establishment is commercially using
a TSCA substar. that is neither contained on the
Section 8(b) Li ;2ntory nor a TSCA exempt substance,
he must look fn’ evidence of knowledge. Knowledge
can be presumed in nearly all caies because the
Section 5 and Section 8 statutory and reguLato y
requirements appear in the Federal Register .
Regulated industries are presumed to know the
contents of relevant regulations and notices that
appear in the Federal Register . While most firms
will, be unable to defeat the presumption of
knowledge, this presumption can be strengthened if
the firm was on an EPA mailing list or attended any
EPA meetings reLevant to the regulation in question.
(Headquarters would be responsible for establishing-
these points.) The regional inspector could add
support to the case by:
(1) establishing whether the firm in question
belonged to any cr;de as!sociation,
(2) reviewing a firm’s files for memoranda or
other written evidence recognizing the
illicit nature of a substance’s production,
and
(3) reviewing a firm’s files for Federal
Register notices indicating that a substance
was still undergoing PMN review or was
banned by a Section 5(e) or Section 5(f)
order, rule, or injunction.
Enforcement Strategy August. 1 980
Section 5:
Prernanufacture Notification
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3 rt Three 3aSeciion 5 Insoection Procedures
If evidence ofknowledge is not available at the
pLant, it may be necessary to subpoena such material
from corporate headquarters or wherever the
information is kept. In this situation, the
inspector would give the problem to the enforcement
staff of the Regional Office.
ToncomDliauce with Test Marketing Exemntion Restrictions
A firm may test market a new substance without submitting the
substance for Section 5 review under a Section 5(h)(l) test
marketing exemption. The firm must still submit a request
containing sufficient information to allow the Agency to
determine whether the substance might pose an unreasonable risk
during test marketing. Under this exemption, the Administrator
may impose appropriate restrictions on the test marketing of
the substance. There are two types of restrictions: those
that restrict production, distribution, disposal, or use of the
substance and those that require recordkeeping.
• Restrictions on Prodi ction . Distribution, or Use
The o jectiva of these inspections is to determi.ne
compliance with the restrictions in the test
marketing exemption. The restrictions (i.e any) will
dictate to the inspector what aspects of the
substance’s production and distribution are to be
monitored. If the exemption limits production to
1,000 lbs. per month, the inspector will check
shipping, production, and sates records to determine
how much of the substance is really being produced.
If the exemption limits distribution to a two—state
area, the inspector should examine shipping records
to determine if any of the destinations were outside
of this two—state area. The firm may also have
committed a failure to notify violation. For a
discussion of the failure to notifT issue, see the
inspectional procedures for that PLolation on page
15.
• Record ee ing Requirements . The objective of these
inspections is to establish whether the firm is
keeping those records required by a test marketing
exemption. The inspector should review any
recordkeeping requirements stated in the test
marketing exemption approval or accompanying letter
and then determine i.E the records kept by the firm
meet those requirements.
Enforcement Strategy August. 1 980
Section 5: -
Premanufactwe Notiftcation
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Part iriree 3a Section 5 Inspection Procedures
Tor1comD1iance with Research and Develaoment ExemQtion
Restrictions
A firm may produce a new substance for the purpose of research
and development without submitting the substance for Section 5
review under a Section 5(h)(3) research and development
exemption. Under thLs exemption, the firm must comply with
certain statutory requirements. Three violations of this
exemption are possible.
• Overproduction
• Failure to adequately warn employees
• Failure to use the substance for research and
development.
The objective of these inspections is to determine if the
manufacturer is complying with the statutory restrictions
relevant to the research and development exemption. (Note that
this is an automatic exemption. Consequently, there will be no
. a i tion request to guide the inspection.)
Th procedures for these inspections will vary with the type of
violation the inspector is looking for, although the inspector
should look for all three of the previously mentioned
prohibitions for possible vi.olations whenever a firm claims a
research and development exemption. Such a claim may be made,
for example, following a failure to notify inspection where a
new substance is found.
• Overproduction . The inspector should review the
firm’s production records to determine bow much of
the substance is being produced. Then he should
consult with OPTS following the inspection to
determine if the amount produced exceeds what is
reasonably required for research and development. If
any overproduction violation is established, the
inspector should also review the ‘firm’s shipping,
sales, and storage records to determine if the firm
is coemercially distributing the substance for a
nonresearch and development, use. Overproduction
strongly suggests illegal commercial distribution of
the substance. Any such distribution constitutes a
failure to notify violation.
• tnadeguate Warnings . The inspector first must
determine if the substance is suspected of being
hazardous. The’ firm might volunteer this
information. If it does not, the inspector should
- Enforcement Strategy 3—10 August. 1 980
Section 5:
Premariufacture Notification
-------
ai ‘‘tree 3a Section 3 Ins ec:jon Procedures
present his information to OPTS following the
inspection for a ha.z.ard determination. If the
substance is hazardous, the inspector should review
what warnings were given to the firm’s employees.
(U they are written out, they should be
photocopied..) Then the inspector should interview
those employees who worked with the new substance to
determine (1.) if they were all warned, (2) the extent
of the warning, and (3) if the employees understood
the warning.
• Monresearch and Develooment Use . The last violation,
not using a new substance for research and
development, occurs when a manufacturer claims that
the new substance it is producing is only being used
for research and development. Thus, it would claim
the automatic exemption. The inspector should verify
this claim by examining the manufacturer’s evidence
of research and development such as research data on
the substance in question or contracts to perform
research and development on the substance. These
doct ments should be photocopied. If the evidence of
research and development seems questionable, the
inspector should review the firm’s production,
shipping, and sales records to see if any of it is
being commercially distributed for non—research and
deve. . pmeat purposes.
The absence of research and development data or
contracts strongly suggests a research and
development violation. If the inspector finds
evidence of improper commercial distribution, the
firm has clearly committed both this violation and a
“failure to notify” violation. For discussions of the
latter violation, see the inspection.al procedures
below.
Withholding Material Information from or Submission of
Materially False or Misleading Information on a Section 5
otice or Exeinotion Reauest
This violation occurs as a result of the withholding of
material information, from or submission of materially false or
misleading information on a Section 5 notice or exemption
request. A statement is material if the Agency wou Ld have or
in fact did rely on it in making its decision not to regulate a
new substance or allow an exemption. aeadquarters will direct
what parts of the Section 5 notice or exemption request need
Enforcement Strategy August. 1 980
Section 5: 3— Il
Premariufacture Nozif cation
-------
rt Iree 3a Section S nspec:ion Procedures
verification. The inspector must take the Section 5 notice,
the exemption requests or excerpts of these documents into the
facility and verify the information contained in certain
portions of the form. For example, the inspector may wish to
see if the substance is being disposed of in accordance with
procedures stated in the Section 5 notice, or if waste gases
are being scrubbed prior to release into the air.
• Review of Section 5 notices and exemption reOuests .
The inspector will need to review the appropriate
forms before conducting the inspection in order to
become familiar with the parts of the forms that
require attention.
• Verification . In verifying the information in the
forms, the inspector may have to photocopy relevant
records, and take process emission and effluent
_sampLe -
Failure to Notify
The inspector will be looking for evidence that a new substance
is being manufactured, processed, imported, or exportedfor
non—exempt purposes. This violation has three major variations
which will require three different inspectional approaches.
The approach will, dictate the procedure for this inspection.
• Unidentified ‘ew Substance . The first approach is
used where the inspector does not suspect any
violation but discovers a new su bstance being
improperly produced. There are five steps to follow
in this type of inspection.
Printout . For each firm selected for inspection,
Readquarters will provide a printout of all
substances that this firm has reported for the
Inventory, their CAS numbers (iif available), and
their inventory reporting fork number (if
available).
Examine Records . The inspector should examine
shipping records (bills of lading, purchase
forms, etc.) storage records, and production
records for new substances.
Inventory Stat’is . The inspector should then
determine if any of the substances are not on the
Inventory. The inspector would first check each
chemical in the records against the printout.
- Enforcoment Strategy 3—12 August. 1 980
Section 5: -
Premanufacture Notification
-------
3 a r r s 33 S e on 5 Inspection Procedures
Substances 1ot on Inventory . If there are
substances not on the printout, then the
inspector should obtain the chemical specific
name for these substances and compare them to the
Section 8(b) Inventory, both the confidential and
nonconfidential parts, and any supplements. (The
firm must provide the chemical specific name of
the substance on request. See footnote at page
3—6.)
Establishing a Violation . If there are
substances that are: CL) not on the Inventory,
(2) covered by TSCA (i.e., not a pesticide, food,
food additive, drug, cosmetic, device, specified
nuclear material, firearm, ammunition, tobacco,
or tobacco product), (3) covered by the Section 5
regulations i.e., not a mixture, coproduct,
impurity, byproduct, or a chemical substance that
occurs incidential to production activities, and
(4) not covered by a Section 5 exemption, the
inspected estb lishment has committed a “failure
to notify” violation*. (See proposed regulations
for Section 5, Section 720.2, Section 720.13,
Section 720.14, and Section 720.1,5 at 44 Federal
Register . 2264—68 (January 10, 1979).]
• Identified New Substances . In the second approach
for failure to notify violations, the Agency will be
looking for a specific new substance that is being
illegalLy produced in a particular establishment.
For example, the establishment was denied an
exemption from Section 5 review, the notice for the
chemical was rejected as deficient and never
resubmitted, or the Agency is routinely checking the
records of Section 5 notice submitters for premature
production. In these cases, thera’is a significant
possibiLity that the firm in question has produced
the new substance without a complete Section 5
review.
* Until the closing of the revised Inventory, processors may
process a substance for TSCA purposes that was not reported for
the Inventory but was either manufactured for research and
development prior to JuLy 1, 1979 or was manufactured at any
time for a non—TSCA use.
niorc ner t S a a y 3—13 Auc .sZ. 1 980
Section 5:
Premanu acture Notification
-------
Part Tt’res 3a Section 3 ins eciicn Pro dur i
Chemical 1ames . To perform this inspection, the
inspect or will need to know the tradename,
generic name(s), and the chemical specific name
of the new substance.
Review of Records . The inspector will then look
for the particular chemical in the firm’s
shipping, production, or storage records. Should
the inspector find evidence of a violation, he
should photocopy all relevant records and take a
sample if possible.
• Substance tdentified by Associated Section 5
Violation . In the third approach, the inspection will
result from some other Section 5 violation
(withholding information or submitting a false or
misleading sub•mission, improper test marketing, and
improper research and development). Th Li. itial
violation will lead inspectors to suspect that a
“failure to notify” has also occurred. in these
situations, the exact chemical the inspector is
looking for is known.
Withholdia t iformation from or Submission of
False or Misleading Information . If ie firm
submitting the invalid notice or exemption
request begins producing the new substance for
commercial distribution, it has committed a
failure to notify violation. Once an inspector
detects a. withholding information or false and
misleading violation, he should examine the
firm’s production and shipping records to see if
the substance was commercially distributed.
Noncomvliance with Test Marketip Restrictions .
If the exemption holder produc s nore than the
limit stated in its exemption, then it has
violated the terms of its test marketing
exemption. If the overproduction exceeds the
stated Limit by 100 percent and the excess is
commercially distributed, then the EPL will
consider it also a failure to notify violation.
The inspector needs only to review the firm’s
production and shipping records to ascertain the
extent of the overproduction.
riTorcsrnerIc 3—14 August. 1 980
Section 5:
Pramariufacture Notification
-------
P3. t j a Sec uon S Ins dc ICn P?ocedures
Noncom 1iance vith the Terms of a Research azid
Develooment ExemDtLon . U a firm claims it is
manufacturing and/or distributing a nev substance
under a research and development exemption, but
the evidence demonstrates that some or all of it
is not being used for research and development 1
that firm has probably committed a violation of
the terms of its research and development
exemption and a failure to notify violation. The
evidence gathered by the inspector for the
research and development violation will, also
e tabLish the failure to notify violation.
- E crc rne ,t S :s’y 3—15 AUgUS . 1 9 O
Sec iori 5: -
Premanufacture Notification
-------
3a Sec tan 5 Inso,c ion Pvoc dutes
Enlcrcarnern S ra e y 1 980
Sec on 5:
Premariufacture Notification
-------
Pan Three
3b
Section 5
Neutral Administrative
Inspection Scheme
Two neutral administrative inspection schemes for use in
targeting TSCA Section 5 inspections are discussed is the
following section. The Section 5 notice review program is is
its initial stages and many of the program elements will not
become .fulLy operational until some time in late Ft 80. Thus,
the Office of Enforcement (OE) is proposing both an initial
scheme to cover this interim period and a final one to become
effective when the Section 5 program is fully operational.
There are seven violation categories in Section 5:
1. NoncompLiance with a Section 5(e) or Section 5(f)
order, ruLe, or injunction;
2. “Failure to notify” EPA of the manufacture or
importation of a new substance;
3. Withholding material information from or submitting
materially false or misleading information on a
Section 5 notice or exemption re4uest;
4. Using a substance produced in violation of Section 5
for commerciaL purposes;
5. Noncompliance with the terms of a test marketing
exemption;
6. Noncomplianc.e with the terms of a research. and
development exemption; and
7. Violation of Significant Tew Use Rules (SNURs).
Enforcement Srategy 317 August, 1 980
Section 5:
Prernanuiacflne Notificatfon
-------
3(! Three 3b Section 5 Neutral Admini tranve lflSp Ct , Scheme
During the first several months of operation, OE anticipates
that the only active violation categories will be:
noncompliance with Section 5(e) and Section (f) orders, rules,
or injunctions, “failure to notify”, withholding material
information from or submitting materially false or misleading
information on a Section 5 notice or exemption request, and
commercial use of an improperly produced substance. Thus, OE’s
initial efforts will focus on these four categories. When. the
other categories become active sometime in F! 81, OE wilL shift
to the fimal. neutral administrative inspection scheme which
includes the other violation categories. OE recognizes that
the schemes will change as the Agency develops expertise in
handling the enforcement of Section 5.
Interim Insnection Scheme
• Noncomnliance with Section 5(e) or 5(f) Orders.
Rules, or Injunctions
1. Inspect all firms subject to such orders, rules,
or injunctions
• Failure to Notify*
1. ALL members that are the subject of improper
production tips and/or complaints
2. ALL firms that applied unsuccessfully for Section
5 exemptions
3. ALL firms that have initiated but never completed
a Section. 5 notice submission because of
uncorrected defects in the submission
4. All, firms with a history of both new chemical
production and of highly toxic substance
production
(a) All firms with primary manufacture in SEC
code 2869
(b) All, firms with, primary manufacture in SIC
code 2865
Cc) ALL firms with primary manufacture in SIC
code 2821
* All the firms in Failure to Notify subcategory 4 are the sae
as those in Commercial se Violations subcacegory 3.
Consequently, selected firms should be checked. for both
violations when they are inspected.
- Erifor emer t Strategy 3—18 August. 1 980
Section 5: -
Premanufacture Notification
-------
?‘art r:,tee 31 Section 5 Neutral Adrn,ntscrQtIve Ine ec:ion Scpienie
5. All. firms whose Section 5 notice submissions have
been extended
• Withholding MateriaL Information from or Submission
of Materially False or Misleading Information on a
Section 5 Notice or Exemotion Reguest
1. All category members that are the subject of
“withholding information” or “false or
misleading” complaints and/or tips
2. Firms whose PMN form indicated significant levels
of projected production, importation, or
- exportation
• Commercial tise of an Illegally Produced Substance*
1. All firms that are the subject of commercial use
tips and/or complaints
2. All firms listed as recipients of improperly
produced cbemcials
3. All. firms with a history of both new chemical
production and of highly toxic substance
production
(a) ALL firms with primary manufacture in SIC
code 2869
(b) ill firms with primary manufacture in. SIC
- code 2865
• Cc) ALl firms with primary manufacture in SIC
code Z82L
* All the firms in Failure to Notify subcategory 4 are the
same as those in Commercial tise Violations subcacegory 3.
ConsequentLy, selected firms should be checked for both
violations when they are inspected.
Enforc mentSc;ategy 319 August. 1980
Section 5:
Premanufacture Notification
-------
Par. Three 3b Sec ,on 5 Neucra Adm ,nusuaiive Insoecnon Schema
Discussion of Interim Scheme
The interim scheme presented above is divided .firsc into four
violation categories. Each of these categories is divided
further into criterion—defined subcategories. The criteria
used are neutral inspection triggers, and they define
subcategories of the violation categories. In the interim
scheme’s “failure to notify” violation, for example, there are
five subcategories. Three of them are: (1.) all category
members who are the subject of failure to notify complaints or
other information indicating a failure to notify violation,*
(2) a1L firms that have applied unsuccessfully for Section 5
exemptions, and (3) all firms that have initiated but never
completed Section 5 submissions because the forms were rejected
as deficient and never remedied.
Priorities and Resources
The order of the “olation category and of the subcategories
indicates the priority among the categories and subcategories.
The violation priorities are based upon the seriousness of the
violation. The subcategory priorities are based upon the
likelihood that the members of a particular subcategory would
commit that violation. If the Agency has insuffici ent
resources to do a complete compliance monitoring program,
enforcement efforts in Lower priority violations should be
reduced. If a Region’s resources are still insufficient to
cover the remaining violation categories, the lover priority
subcategories in. the remaining violation categories shouLd be
eliminated. Each Region must evaluate what resources wiLl be
availabLe for Section 5 inspections and then decide how much of
the scheme can be carried out. These decisions must be
documented so that a court reviewing a Region’s Section 5
inspection will see that it is based on neutral criteria and
not oost fl rationalizations.
* CE recognizes that many of these complaints will furnish
adequate probable cause to obtain a civil probable cause
warrant regardless of this scheme. They are included here so
that this scheme can be used as a tool Ear the allocation of
all inspectional resources.
Enforcement Strategy 3—20 August. 1 980
Section 5: -
Premanufacture Notification
-------
: 3b Sectiar 5 Neu raI AomunisIra ive Insoection Scr eme
For those Regions unable to execute the full interim scheme,
the following modifications are suggested:
• Failure to Notify
Only subcategory 4 will require a significant amount
of resources. Thus, a Region would only inspect in
order of priority:
• All those firms in subcategories 1, 2, and 3,
• All those firms in subcategory 4(a) (SIC Code
2869),
• ALL those firms in subcategory 4(b) (SIC Code
2865) only if all the firms in 4(a) have been
inspected.
• All those firms in subeategory 4(c) (sic Code
282].) only if all, the firms in 4(b) have been
inspected.
• Commercial Use of an Ille allv Produced Substance
Only subcategory 3 will require a significant amount
of resources. Thus a Region would only inspect in
order of priority:
• ALL those firms in subcategories I and 2,
• ALL those firms in subcategory 3(a) (SIC code
2869),
• All those firms in subcategory 3(b) (SIC code
2865) only if all the firms in 3(a) have been
inspected,
• All those firms in subcategory 3(c) (SIC code
2821) only if all the firms in 3(b) have been
inspected. -
It should be noted that if any these triggering criteria
produce a subcategory that is too large, the selections in that
subcategory can be randomized. For example, if there are only
enough resources to inspect 50 percent of the members of a
subcategory, the Regional Inspection Division will select half
of the category members on a random basis.
Erforcerient Strategy 3—21 August. 1 980
Section 5:
Prernanufacture Notification
-------
Pati r ,ree - 3b S c ion 5 Neutral Adrrnn stracive InsQectlon Scheme
Discussion of Final. Scheme
Sometime in FT 81, OE will issue the final. neutral
administrative ins.peccion scheme for Section 5. The final
scheme will. contain two additional violation categories, test
marketing violations and research and development violations.
This does not mean chat we will. not prosecute these violations
if they are found prior to the issuance of the final scheme but
only indicates that OE will have no affirmative monitoring
programs for these violations until FT 81. (At some point in
.the future, OE will add violations of significant new use rules
(SNtTR) to the targeting scheme. The general SNUR program will.
probably not be fully opperational untiL Late FT 81 at the
earliest. Nevertheless, there will probably be SNURs for
specific chemicals some time this year.)
Another significant change in the final scheme will be the
incorporation of random subcategories in all. but one of the
violation categories. This will. Eacili: ite the statistical
evaLuation of the targeting scheme’s tiveness. (See
Evaluation of Targeting Scheme, below, frn a discussion of this
evaluation.) -
EvaLuation of Tar etinz Criteria
Since the Agency will. not have enough resources to inspect
every firm regulated under TSCA, it is crucial that those
groups of firms most Likely to violate Section 5 be inspected.
The subcategories under each violation address this concern,
but it is possible that those criterion—defined subcategories
might produce a group of firms no more Likely to violate TSCA
than if the firms were selected at random. Thus, it is
important to periodically review the effectiveness of the
targeting criteria.
OE can review these criteria by statistical’ly evaluating the
violation rates of each criterion—defined subcategory in
comparison with the random subeategory of the same violation
category. The violation, rates of each subcacegory will be
statistically compared to the random subcacegory. (If a firm
is selected both in a criterion—defined subcategory and the
random suboacegory, the results will be counted in both.) In
this way, OE will, determine if there is a significant
difference between, the rate of violation of a particular
criterion—defined subcategory and. the random selection of the
members in that entire violation category. If there is no
significant difference, then OE will realize that the criterion
in question should be dropped.
Er forcement S ategy 3—22 August. 1 980
Section 5:
Premanufacture Notification
-------
Pan Trues
3c
Section 5
Penalty Policy Guidance
The Section 5 penaLty poLicy is based upon the general TSCA
Civil Penalty Policy of March 10, 1980. The authority to issue
civil, penalties is round in Section 16 of TSCA. Under Section
16, the Agency determines penalties in a two step process.
First, EPA determines a “gravity based penalty” (GBP) based
upon four statutory factors: nature, extent, circumstances,
and gravity of the violation or vioLations. These factors are
incorporated into the General TSCA Penalty Matrix (Matrix I on
page 3—25). This matrix allows the determination of the gravity
based penalty. The Agency then adjusts the GBP upward or
downward by the violator’s ability to pay, ability to continue
in business, violation history and degree of culpability. In
addition, the penalty may be adjusted by “other factors as
justice may require”.
This document contains two sections. The first is a summary of
the Section 5 penaLty policy. It allows the case preparation
officer to efficiently determine the GBP and then make the
appropriate adjustments. The second section, is a detailed
explanation of the Section. 5 penalty policy:
Sumarv of the Policy
Determining the Gravity 3ased Pena1t
The gravity based penalty, based on nature, extent, and
circumstances of the violation is determined by the General
TSCA Penalty Matrix reprinted on page 3 .25 (Matrix I). The
case preparation officer will. determine the 1) nature, 2) extent,
Eriforcemern Strategy 3-23 August. 1 g80
Section 5:
Premanufacture Notification
-------
jr 3c Section 5 Penalty Policy Guidance
and 3) ci cumstances of the vioLation separately by. using this
summary. The case preparation officer will then plug these
values into the general matrix. This will yield the gravity
based penalty. The GB? will be adjusted through the
application of the other factors stated in Section 16 of TSCA.
The application of those adjustment factors is found in the
general TSCA Penalty Policy of March 10, 1980 on pages 9—16.
Nature of the Violation
The nature of TSCA violation depends on whether the violation
relates to chemical control, control—associated data—gathering,
or hazard assessment. It is important to make this
determination first as the other three initial factors depend
on this determination. (See Matrices El and III on pages 3—27
and 3—28 respectively.) The following lists place the
violation types in their respective nature determined
categories.
1) Chemical Control Violations
• Noncompliance with. Section 5(e) or Section 5(f)
orders, rules, or injunctions (those aspects dealing
with the actual control. of the substance)
Noncompliance with research and development exemption
restrictions (noncompliance with the adequate warning
requirement)
. Commercial use of an ilLegally produced substance
• Noncompliance with test marketing exemption
restrictions (those aspects dealing with the actual
control of the substance)
2) Control—Associated ata—Gathering ViJlations
• Noncompliance with Section 5(e) or Section 5(f) -
orders, rules, or injunctions (those aspects dealing
with record keeping)
• Noncompliance with test marketing exemption
restrictions (those aspects deaLing with record
keeping)
Er tforcernent Strategy 3—24 AUgUSt. 1 980
Section 5:
Premanufactu,e Notification
-------
3r .iree
3c Section 5 Penalty Policy Guidance
Mat:Lx I
Geceral TSCA ?e 1 y Ma ix
EXTENT 0 ’ POTINTLU. DA !AGE
i1iorcem em Strategy
Section 5:
Premanufacture Notification
3—25
August, 1 980
EIGK RLNGE
A
MAJOR
1. $25,000
2. 20,000
C
MINOR
B
S IGNTYICANT
$17,000
14,000
CI1CUS TA TC!S
(PRoa ILIr ’
OF
DAMAGES)
$3 ,000
3 ,oO _ \
MID
3ANGL
3.
4.
13,000
10,000
10,000
7,000
1,500
1,000
3.
5,000
3,000
500
LOW
RANGE
6.
2,000
1,500
250
-------
Part Triree 3c Section 5 Penalcy Policy Guidance
3) flazard Assessment Violations
• Failure to notify (all violations)
• Withholding material information from or submitting
false or misleading information on a Section 5 notice
or examption request
• Noncompliance with research and development examption
restrictions (overproduction)
• Any violation not Listed •Ln the above three
categories
Extent of Violation
Extent is based upon the amount of substance involved in the
violation and the nature of the vioLation. The case
preparation officer should use the nature determination from
the previous page and select the appropriate nature category in
Matrix II. Then he or she should select the appropriate weight
column and read up the column for the extent determinatio .
Circumstances of the Violation
The circumstances determination is based upon the probability
that harm could have actuaLly taken place. Matrix III provides
the following Levels for measuring circumstances:
Levels I and 2 (Kigh) — the violation is likely to
cause damage
Levels 3 and 4 (Medium) — there is a significant chance
that damage,will result from
the violatLon
Levels 5 and 6 (Low) — there is less Likelihood that
damage will result, from the
violation than from a Level
3 or 4 violation.
Er.forcernent Strategy 3.26 August. 1980
Section 5:
Premanufacture Notification
-------
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-------
P3rt Three 3c Section 5 Penalty Pøli y Guidance
The factors used in considering circumstances vary with the
nature of the vio lation. These factors are presented below and
summarized in Matrix III on page 3—28. The case p eparacion
officer should use the previously determined nature designation
and select the appropriate nature category in Matrix III. Then
he or she should select the appropriate circumstances found in
that category and read up the column for the circumstances
determination. The appropriate circumstances are determined by
a two step procedure. First an initial circumstance Level is
Set. Then adjustment factors are applied to increase or
decrease the level of Circumstances.
Chemical Control Violations . The determination of
circumstances depends on severity (the initial circumstance
level) and exposure (the adjustment factor).
1) Initial Circumstance Level:
• for “nncompliance with 5(f) orders, rules 1 or
injunctions 1 the initial circumstances level is 2.
• For the other violations in this category, the
in .tiaL circumstances level is 3.
2) Adjustmeflt Factors:
• If the substance never left the violatorts premises,
reduce the initial, determination by one level.
• If the substance was further processed by another
firm, the initial circumstances level, remains the
same.
• If the substance was packaged for •commercial
distri,bution but never shipped to’ the retail
distributor, the circumstance level increases by one
level. -
• If any of the product was distributed to consumers or
was reLeased uncontrolled into the environment, the
circumstance Level will be increased by two Levels.
Control—Associated D ’ata—Gathering Violations . There are two
factors- to consider in determining the circumstances level, for
these vioLations: 1) the degree to which the Agency’s ability
to monitor and/or evaluate the substance is impaired (the
Ertforcernent Strategy 3.29 August, 1 980
Section 5:
Premanufacture Notification
-------
ar Three 3c Section 5 Penalty Policy Guidance
initial circumstance level) and 2) the availability of the
missing information from other sources (the adjustment
factor).
1) InitiaL Circumstance Level:
• If the violation seriously impairs the Agency’s
ability to monitor and/or evaluate a substance, the
circumstance Level wiLl, be 2.
• If the violation impairs the Agency’s ability to
monitor and/or evaluate a substance in an important
way, the circumstance level will be 4.
• If the violation impairs the Agency’s ability to
evaluate and/or moniter a substance in a Less than
important way, the Level will be 6.
2) Adjustment Factor
• If the missing information cannot be produced by the
firm within five wor cing days, the circumstance’
determination viii be increased by one level.
azard Assessment Violations . The overriding consideration in
a circumstances determination in this violation category is the
type of vioLation involved (the initial circumstance Level).
The second consideration is the presence of aggravating factors
(the adjustment factors).
1) Initial Circustance Level
• Failure to notify and withholding false or misleading
information violations automatically receive a level
of 2.
• Overproduction of a research and aevelopment
substance receives a level of 6.
• Any hazard assessment violation not Listed above
receives an initial Level of 4.
2) Adjustment Factors
• Should. any of the substance produced pursuant to
failure to notify, or withholding false or misleading
information vioLations be distributed to consuners,
the circumstance range would be increased to the
highest level.
Enforcemertt Strategy 3—30 August, 1 980
Section 5:
Premanufacture Notification
-------
Part Three 3c Section 5 Penalty P Iicy Guidance
• For the overproduced research and development
substance, if the violator cannot account for all the
overproduced. substance at the time of inspection, or
if some of it reaches consumers then the circumstance
level is increased to leve]. 5.
Gravity
No separate determination is needed for the gravity factor
because this has already been taken into consideration by the
other three factors.
Adjusting the Gravity Based Pena1t
Follow the adjustment factor application instructions as
presented in the general TSCA penalty policy document, “TSCA
Civil Penalty System” of March 10, 198C at pages 9—16. The
only addition. to these instructions ¶. .j.i be La adjustment
factor 4, economic gains from noncompLi ca. Kere the penalty
should equal the gross sales of the illegally produced prnduct.
The penalty should, in any case, not exceed the $25,000 per day
statutory Limit following the application of adjustment factor
14 •
T.m osinz Penalties on a Per Dcv Basis
VioLations that are designated “continuing” may be penalized on
a per day basis; noncontinuing ones are penalized for one day
only. The following are two lists of v .oLations; one list
contains continuing violations and the other contains
noncontinuing violations. The criteria for separating these
violation types into these two categories are found on page
3—40. In continuing violation situations,, t t penaLty will be
assessed on the basis of the a ounr of substance involved in
that 24 hour period.
Continuinz Violations
Noncompliance with Section 5(e) and Section 5(f)
orders, rules, and injunctions (those aspects dealing
with controlling the substance).
• Noncompliance with research and development exemption
restriction (vioLation of overproduction
requirement).
Eritorcement Strategy 3—31 AuguSt. 1 980
Section 5:
Prernanufacrure Notification
-------
3r Three 3c Section 5 Penally P ltc Guidance
• Commercial. use of an illegally produced subs.tance.
• Noncompliance with test marketing exemption
restriction (those aspects dealing with controlling
the substance).
• Failure to notify.
Noncontiauing Violations
• Noncompliance with test marketing exemption
restriction (record keeping aspects).
• Noncompliance with Section 5(e) or 3(f) orders,
rules, or injunctions (record keeping aspects).
• Noncompliance with research and development exemption
restriction (violation of the adequate warning
requirement).
• Withholding materiaL information from or submis ion
of false or misLeading information on a Section 5
notice or exemption request.
When a penalty is assessed on a per day basis for a continuing
violation, care must be taken to assure that the adj 3tment
factors for utgovernment clean up costs” and “economic benefits
from noncompliance” 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,
$10,000 in costs should be added to each day’s penalty
(although each day would still be Limited to a maximum
$23,000).
ExamD I e
A. hypothetical firm was found to be producing a new TSCA.
substance that had never been submitted to EPA. for PMN review.
The violator voLuntaril.y recalled all shipments of the new
substance. The firm had produced 2,000 pounds per day of the
substance over a two month period and had grossed $150,000 from
mostly local sales of the producr, but none of it reached
consumers. The. violator was aware of the PMN requirements as
it had been fined two years earLier for producing a substance
before expiration. of its PMN review. The facts indicate that
the violator mistakenly believed that it was producing a
- Enforcement St;ategy 332 August. 1980
Section 5:
Premanufacture Notification
-------
ree — _________________ - 3c Section S Penalty P lcy G&sidance
substance that was already on the inventory. The gross annual
sales of the firm is $3,500,000. (The penalty is v orked out on
the worksheet at page 3-34.)
This is a hazard assessment type violation. The extent is
major as the violator produced 2,000 lbs. per/day of the
substance. The circumstance analysis requires consideration of
the type of violation involved and the presence of any
aggravating factors. The initial circumstance assignment is 2
because the violation requires a high determination in each
case. This initial determination is not adjusted upvard
because none of the new product reached consumers. This
results in a gravity based penalty (GBP) of S20,000 per day.
The violator had sufficient knowledge to recognize that his
conduct constituted a violation of Section 5. Had the firm
taken greater care in adhering to the requirements of Section
5, the violation would have been prevented. Consequently,
there is a level 2 cuLpability which yields no initial
adjustment to the Gaps But the recall of the product by
manufacturer is evidence of a good attitude and the penalty is
adjusted dov by 15%. -
The firm has one prior violation. It is not an identical
violation (production prior to notice expiration, a variation
of failure to notify), but they are “closely similar” as both
invoLve the illegal manufacture of a new substance. Thus, the
penalty is adjusted upward by 50 percent. The sum of this
adjustment upward and the culpability adjustment factor is an
adjustment upward of 35% (50% — 15% — 35%). The penalty is
increased to $27,000. This exceeds the maximum allowable
penalty of $25,000; therefore, the penalty is reduced by $2,000
to reach. that amount.
The violation took place over a two—month period of time. The
penalty amount is multiplied by 60 days to eld $1,500,000.
There were no government clean up costs from the violation as
al]. the shipments were voluntarily recalled. The economic gain
was $150,000.. The penalty far exceeds this amount and need not
be adjusted. to reflect the economic gain.
The violator claims it cannot pay that Large a fine and proves
that its gross sales. is only $3,500,00G anually. The 4 percent
gross sales yields a. figure of $].40,000. thus, the penalty
would be $140,000.
Ert oreemern Strategy 333 August. 1 980
Section 5:
Premanufacture Notification
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CIVIL PENALTY ASSESSMENT WORKSHEET
Name of Respondent: _______________________________________
Address of Respondent:
(1) CompLaint 1.0. Number: ___________________________
(2) Date Complaint tssued: __________________________
(3) Date Answer Received: ____________________________
(4) Date Default Order Sent: __________________________
(5) Date Consent Agreement Signed:
(6) Date Final Order Sent: ___________________________
(7) Date Remittance Received: ___________________________
1. Gravity Based Penalty (GBP) from matrix . . . $ 20 .000
2. Percent i.ncrease or decrease for
culpability . . . . . . . . . . . . . . . — 15 Z
3. Percent increase for violation history . SO Z
4. Add Lines 2 and 3 . . . . . . . . . . . 35 %
5. Multiply GB? by percentage total on Line 4 . $ 7.000
6. Add Lines 1 and 5 (subtract line 5 from
line 1 if negative percentage) $ 27 .000
7. Enter line 6 amount or $25,000 whichever
is less . . . . . . . . . . . . . . . . . . $ 25,000
8. MuLtiply line 7 by the number of days
of violation. $ 1.500.000
9. Government clean—up costs, if any $ 0
10. Economic gains from non—compliance,
if appropriate - $ 0
11. Add lines 8 through 10 . . . . . . . . . . . $ 1.5.00.000
12. TotaL of other adjustments as just.i.ce
may require $ 0
13. Add. (or aubstract) Line 13 to
(from) Line 12* . . .. . . . . $ 1.500,000
14. Mazimum penalty for small firm (4 of
gross receipts) if applicable and the
information is available . . . . . . . . . . $ 140.000
*Ljfle 13 shouLd be the proposed penalty for a given violation
unless the small firm factor is applied. The procedure is
repeated for each violation.
3—34
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ar Trree
3c Section 5 Ps
nalty Policy Guic ance
Detailed Back round of
the Section 5 Penal.tv Policy
This section states the rationale behind the policy summarized
in the first portion of this document.
Nature of the Violation
The nature of a Section 5 violation depends on whether the
violation deals with chemical controL, control—associated
data—gathering, or hazard assessment.
1. Chemical control regulations are aimed at minimizing
the risk presented by a chemical substance by
placing constraints on how the substance is handled.
Subsections 5(e) and 5(f) authorize a wide variety
of chemical control requirements from labelling
restrictions to total manufacturing bane,
Subsection 5(h)(J.) authorizes the Administrator to
impose restrictions upon the manufacture or
processing of a test marketed substance. Violations
of those restrictions that place constraints on how
a substance is handled fall into this category
Subsection 5(h)(3) obligates a firm producing a
substance under a research and development exemption
to give adequate warning to employees if that
substance is dangerous. This, too, is a constraint
on a substance’s handling and is included in this
category. Such a violation is mere a worker
protection Law than a toxic substance control Law
and may ultimately be enforced by the Occupational
Safety and. !ealth Administration. aovever, for
penalty policy purposes, OE will, consider it a
chemical control question.
2. Control—associated data— at ’nerin requirements are
recordkeeping and/or reporting re 1 quirements
associated with a chemical cotirrbL regulation.
These requirements enabLe the Agency to evaluate the
effectiveness of the regulation and to monitor
compliance. Some Section 5(e) and Section 5(f)
orders, rules, or injunctions would fall into this
category (e.g. Section 5(e) order that requires the
manufacturer to keep records of all purchases of the
regulated substance). Some test marketing exemption
restrLctions would also fall. into this category as
Section 5(h)(l)(B) authorizes the Administrator to
impose, a=ong other things, recordkeeping and/or
reporting requirements.
Enforcement Strategy 3—35 August. 1980
Section 5:
Premanufacture Notification
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‘an Three 3c Section 5 - Penalty Policy Guidance
3. Hazard assessment requirements are used to develop
and gather information necessary to weigh the risks
and benefits presented by particular chemical
substances and to impose chemical control.
requirements when appropriate. This category
includes violations for failure to notify,
withholding information from or submission of false
or misleading information, and failure to comply
with a research and development exemption
(overproduction). Although the last item does not
fit precisely into the hazard assessment category,
for purposes of the Section 5 penalty policy it
shall. be placed in this category.
Extent of the Violation
Extent is used to take into consideration the degree, range, or
scope of the violation. Matrix I provides three levels for
measuring extent. The three levels are based upon the amount
of substance involved in the violation. This amount will be
determined by the volume of substance involved in the
underlying action that resulted in the violation. Thus if a
firm manufactured 30,000 lbs. of a substance without going
through premanu .facture review, the penalty will be assessed on
the basis of the production records which indicate 30,000 lbs.
illegal production. Production records vi].l generally serve as
the penalty basis in the following violation categories:
• Failure to notify (all variations)
• ouconptiance with Section 5(e) or 5(f) orders,
rules, or injunctions
• 1onconpliance with test marketing exemption
restrictions
• Toncomptiance with research and development exemption
restrictions (all. variations)
If a firm disposes of a substance in violation of test
marketing restriction or Section 5(e) injunction, then the
amount illegally disposed is the basis of the penalty.
The basis for the penalty in the commercial use violation would
be the amount of substance received by the violator.
Enicrcerrierit Strategy 3—36 August. 1 980
Section 5:
Premariufacture Notification
-------
Three 3c Section 5 Penalty Pohcy Guidance
Et should be noted that if those records specified above are
unavailable, the penalty should be assessed on those records
that are available.
The three levels, major, significant, and minor are based on
the standard shipping container of dry substances, the 100 lb.
bag. For the chemical control violations, which are generally
more serious than the violations in the other two categories,
the penalty size increases rapidLy for each bag. The
violations in the other two categories are generally less
serious and the penalty assessment increases more slowly. Thus
the production of three bags of substance in violation of a
hazard assessment requirement is consdered minor whereas the
same amount produced in violation oi a chemical. control
requirement is considered major. The rationale behind these
levels is as follows:
Level A (Major) — Potential for serious damage
to health or the environment
Level B (Significant) — Potential for less than
- serious but more than minor
damage to health or the
environment
Level C (Minor) — Potential for minor damage
to health or the environment
ApnLication of the xtenc Factor to Section 5
1) Chemical control violations . The potential for harm
is greatest in this category because the Agency will
have either knowledge or concerns that the substance
may be harmful. Thus an amount of a substance that
is considered minor in the two other categories may
be considered major here. A ininpr designation
covers amounts from 0 to 100 lbs. (0 to 45.45 kg.);
a significant designation covers amounts greater
than 100 Lbs. to 200 Lbs. (45.45 kg. to 90.90 kg.);
the major designation is assigned to amounts greater
than 200 lbs. (90.90 kg.).
2) Control—associated data— atherin . Since
production, distribution, etc. is always allowed,
the penalties escalate more slowly than for the
chemical control category violations: minor is 0 to
500 lbs. (0 to 227.27 kg.); significant is greater
than 500 lbs. to 1,500 lbs. (227.27 kg. to 681.81
kg.); major is greater than 1,500 Lbs. (681.81
kg.).
- Enforcement Strategy 3—37 August. 1 980
Section 5:
Premanufacijre Notification
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3r “ee 3c Section 5 Penalty ?0I5y Guicance
3) Ha:ard assessment . In this category, the Agency can
neither assume that the substance is harmless nor
harmful. Thus the extent values will be the same as
those in the contro 1—as soc iated data—gathering
category: minor is 0 to 500 Lbs. (0 to 227.27 kg.);
significant is greater than 500 Lbs. to 1,500 Lbs.
(227.27 kg. to 681.81 kg.); and major is greater
than 1,500 lbs. (681.81 kg.).
Circumstances of the Violation
Circumstances are used i.n the penalty policy to determine the
probability of harm actually occuring. In other words, a
variety of facts surrounding the violation as it occurred are
examined to determine whether the circumstances of the
violation are such that there is a high, medium, or low
probability that damage will occur. The case preparation
officer will first use the nature determination to select the
appropriate nature catP: ry on Maxtr .x III (See page 3—28).
Then the officer would select the appropriate circumstances in
that category. Those .rcumstaaces involve a two step process.
The initial Level is set by the overriding circumstance add
adjusted upward or downward depending on other less crucial
factors. The matrix provides the following levels for
measuring circumstances (probability):
LeveL 1. and 2 CEigh) — the violation is Likely to
cause damage
LeveL 3 and 4 (Medium) — there is a significant chance
that damage will result from
the violation
Level 5 and 6 (Low) — there is less likelihood that
damage will result from the
violation ‘han from Level 3
or Level 4 violation.
Apelication of the Circumstances Factor to Section 5
I) Chemical control . For these violations, the initial
cLrcumstance Level is based on the severity of the
violation. When the toxicity of the substance in
question is unknown as in noncompLiance with Section
5(e) actions, noncompliance with a research and.
Enforcement Strategy 3—38 AuguSt. 1980
Section 5:
Premanufacture Notification
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P r Three 3c Section 5 Penalty Policy Guidance
development exemption restriction on adequate
warning, improper commercial use of an illegally
produced substance, and noncompliance with a test
marketing exemption restriction on the use of a
substance, the penalty policy will assign an initial
level, of 3.
When the Agency determines that a substancets
toxicity is unreasonable, as in all 5(f) actions,
the toxicity level, vi.Ll be 2. These initial
circumstance evaluations are adjusted by the degree
of environmentaL exposure. If the substance never
left the violator’s premises, the circumstance range
is reduced one level. If it was processed in
another facility but went no further, the Level
remains the same. If the substance was included in
a retail product but never sold to the public, the
circumstance evalution will be increased by one
level. If any of the n oduct was distributed to
consumers or was re .ea. d uncontrolled into the
environment, the level ‘qili. be increased by two.
2) ControL—associated data— atherirt . For these
violations there are two factors to consider: (a)
the extent to which the Agency’s ability to monitor
and/or evaluate the substance is impaired and (b)
the availability of the missing information.
Violations that seriously impair the Agency’s
ability to monitor or evaluate a substance will
receive an. initial circumstance Level of 2. If the
violation impairs the ability to monitor and/or
evaluate in an important way, the initial
circumstance Level will be 4. If the impairment is
in a less than important way, then-the level will be
6. In all of these cases, if the missing
information cannot be produced by,the firm within 5
working days of the inspection, he circumstance
level will be adjusted upward by one.
3) Hazard assessment . The overriding consideration in
this category is the type of violation involved.
Failure to notify and withholding/false or
misleading violations present such a serious
Likelihood of demage that they will automatically be
assigned an initial circumstance level of 2. If any
of the product is distributed to consumers, the
circumstances range will be adjusted upward to the
highest level. Overproduction of a research and
development substance is a nuch less serious
Eriforcemer ttSt;ategy August. 1 980
Section 5:
Premanufacture Notification
-------
P3r Tr.re 3c Section S P r a y Policy Cuidiincs
violation and is assigned an initial circumstance
level of 6. U the violator cannot account for all.
the overproduced substance at the time of
inspection, or if some of the product reaches
consumers, then the circumstance range is adjusted
upward to the 5 level.
Gravity of the Violation .
Gravity refers to the overall seriousness of the violation. As
used in this penalty system, gravity is a dependent variable
(i.e., the evaluation of nature, extent, and circumstances will.
yield a dollar figure on the matrix that is the gravity based
penalty).
Continuing Violations .
TSCA provides not only that civil penalties may be assessed up
to 525,000 but that each day a violation continues is a
separate violation for which penalties maybe assessed. Thus
TSCA could allow for very large penalties. For some
violations, these large penalties will be appropriate. br
either purely technical violations or for violations whose
underlying action was completed within one 24 hour period,
these large penalties would not be appropriate.. Should a firm
fail, to keep adequate records for a few months as required by
the terms of a test marketing exemption or a Section 5(e) rule,
the violation could result in a penalty as Large as $1,500,000.
Consequently, the Agency should generally not penalize Section
5 violations falling into the control—associated data—gathering
category, research and development exemption restriction
violations (overproduction) and withholding/false or misleading
violations. The ocher violations are inherently more serious
threats to public health or the environmertt and will be subject
to the larger penalty chat a per day analy Ls would provide.
Continuing violations are as follows:
• floncompliance vit r Section 5(e) and. Section 5(f)
orders, rules, and injunctions (chemical control
aspects)
• loncompliance.vith research and development exemption
restrictions (violation of adequate warning
requirement)
• Commercial use of an illegally produced substance
Enforcement Strategy 3—40 August, 1 980
Section 5:
Premanufacture Jotification
-------
part T t e 3c Section 5 Penalty Policy Guidance
• Noncompliance with test marketing exemption
restrictions (chemical control aspects)
• Failure to notify
Noncontinuing violations are as follows:
• Noncompliance with test marketing exemption
restrictions (control—associated data—gathering
aspects)
• Noncompliance with Section 5(e) and 5(f) orders,
rules, and injunctions (control—associated
data—gathering aspects)
• Noncompliance with research and development exemption
restrictions (overproduction)
• Withholding material information from or submitting
materially false or misleading information ot
Section 5 notice or exemption request -
When a penalty is assessed on a per day basis for a continuing
violation, hare must be taken to assure that the adjustment
factors for “government clean up costs” and “economic b,n f its
from noncompliance” are spread over the entire penalty since
these figures are calculated by looking at the entire violative
situation. For example, if a contiuui.ng violation lasted four
days and generated $40,000 in government clean up costs,
$10,000 in costs should be added to each day’s penalty
(although each day would still be Limited to a maximum $25,000
penalty).
Eriiorccrnent Strategy 3—41 August. 1 980
Section 5;
Prernanufacture Notification
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COMPLIANCE STRATEGY FOR THE TSCA §5 (h)(4) PREMANUFACTURE
NOTICE EXEMPTION FOR CHEMICALS USED IN OR FOR INSTANT
PHOTOGRAPHIC OR PEEL-APART FILM ARTICLES
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COMPLIANCE STRATEGY FOR THE TSCA 55(h)(4) PREMANUFACTURE
NOTICE EXEMPTION FOR CHEMICALS USED IN OR FOR INSTANT
PHOTO(RAPHIC OR PEEL—APART FILM ARTICLES
0 V £ R V IEW
Under section 5(h)(4) of the Toxic Substances Control Act
(TSCA), EPA may, upon application and by rule, exempt a new chemical
substance from some or all of the section 5 premanufacture notice
requirements if the Administrator determines that the substance
will not present an unreasonable risk of Injury to health or the
environment. On June 4, 1982, the Agency published a final rule
at 47 Federal Register 24308 (40 CFR Part 723). This rule is an
exemption under TSCA section 5(h)(4) from the premanufacture notice
requirements of section 5(a)(1)(A) for the manufacture and process-
ing of new chemical substances used in or for the manufacture or
processing of instant photographic and peel—apart film articles
under certain conditions. These conditions include: (1) submission
of an exemption notice when manufacture begins, (2) compliance with
certain requirements to limit exposure, and (3) compliance with
recordkeeping requirements found in the rule. The exemption is
limited to the manufacturers of instant photographic or peel—apart
articles who manufacture and process new chemical substances used
in or for the manufacture or processing of these articles. A
peel—apart film article containing a new chemical substance may
iot be distributed in commerce or used until a premanufacture
Dtice under section 5(a)(1)(A) is submitted and the review period
. as ended. The effective date of the rule is July 6, 1982.
A new chemical substance manufactured under the terms of the
exemption will not be added to the TSCA Chemical Substance Inventory.
However, a firm may elect to submit a premanufacture notice (PMN)
for a chemical covered by the exemption, and the chemical will be
placed on the inventory after the notice review period ends and
manufacturing begins unless EPA takes action, such as issuance of
a section 5(e) or section 5(f) order.
Only two firms are believed to be eligible at present for this
exemption. Inspections to insure compliance with this rule will
be incorporated into the section 5 inspection program.
Failure to comply with the terms of the exemption constitutes
a violation of section 15(1)(B) which provides that noncompliance
with a section 5 requirement or rule Is unlawful.
REQUIREMENTS OF THE RULE
ADp1 i cabil Ity
This rule establishes the conditions for an exemption from
1U requirements. In order to manufacture or process a new
-------
chemical substance used in or for instant photographic film
articles, a manufacturer has the option of complying with the
exemption or submitting a premanufacture notice for the specific
C ical to EPA 90 days prior to manufacturing or processing the
,n chemical substance.
This exemption applies only to manufacturers of Instant
photographic or peel—apart film articles who:
1) manufacture the new chemical substances used in or
for the manufacture or processing of the instant photo-
graphic or peel—apart film articles;
2) submit an exemption notice when manufacture begins;
3) limit manufacture and processing of a new chemical
substance to the site(s) listed in the exemption notice;
4) comply with conditions of the exemption in paragraphs
(e). (f), (g), (h) and (j) of section 723.175; and
5) do not distribute in commerce or use a peel—apart film
article containing a new chemical substance until sub-
mission of a premanufacture notice under section 5(a)(1)(A)
of the Act and until the review period for the notice has
ended without EPA action to prevent distribution or use.
o e Requirement
A notice must be submitted to EPA when manufacture of the new
hemical substance under the exemption begins. Table I lists the
nforrnation which must be included in the notice. The notice must
e addressed to the Document Control Officer (TS—793), Office of
esticides and Toxic Substances, EPA. 401 M St. S.W., Washington,
.C. 20460.
ecuirements to Limit Exposure
All manufacturing, processing, and use operations involving
le new chemical substance must be performed in a demarcated,
ecial production area under the conditions found in Table II
,til the substance has been incorporated into a wet mixture,
otographic article, or instant photographic or peel-apart film
ticl e.
The following activities are, allowed outside the special pro-
.iction area provided the conditions given in Table II for these
:tivities are met:
1) Removal of the new chemical substance from the special
production area for storage between operational steps or
for transportation to another special production area.
723.175(e) (8)
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—3—
2) Incorporation of a wet mixture containing the new chemical
substance into a photographic article or instant photo-
graphic or peel-apart film article. §723.175(f)
3) Incorporation of a photographic article Into the. instant
photographic or peel—apart film article. §723.175(g)
Although labeling is required for removal or transportation of the
new chemical substance from the special production area, no label—
Ing is required if the substance has been incorporated into a
photographic article, or if it is contained in a sealed reaction
vessel or pipeline, or If it has been incorporated into an instant
photographic or peel-apart film article. While the rule does not
specifically exclude wet mixtures from labeling, the intent was
that labeling not be required for wet mixtures.
Other Reauirements
Other conditions of the exemption relate to environmental
release, waste treatment, and recordkeeping. These requirements
are given in Tables III and IV. In addition to maintaining the
records listed, the manufacturer must make the records available to
EPA upon written request by the Director of the Office of Toxic
Substances (OTS). These records must be provided within 15 working
days of receipt of the request. This in no way relieves the manu-
facturer from having to make these records available during inspec-
tions conducted in accordance with TSCA section 11.
IEM.DMEt T AND REPEAL
The regulation provides for amending or repealing any term of
the exemption by formal rulemaking i-F EPA determines that activities
under the exemption may present an unreasonable risk. EPA may also
amend the exemption to enlarge the category or reduce the restric-
tions. Furthermore, the Director of the Office of Toxic Substances
may prohibit the use of the exemption if he or she determines that
the manufacture, processing, distribution in commerce, use or
disposal of the substance may present an unreasonable risk. This
prohibition can be accomplished without formal rulemaking.
§723.175(m)
REGULATED INDUSTRY
The regulated industry Consists of those companies who 1) manu-
facture or process a new chemical substance used in or for instant
Dhotographic or peel—apart film articles and 2) manufacture the
article and 3) submit an exemption notice. EPA is aware of only
two companies which meet the first two requirements — Polaroid and
Eastman Kodak. Therefore, they are the only two companies expected
o be eligible for the exemption. Each of these firms has several
tes where chemicals may be manufactured under the exemption.
•,e designation of the location of manufacturing sites is required
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-4-
in the exemption notice.
N FOR C E MEN T
•JJFORCEME}JT GOALS
The goal is to assure compliance with the terms of the exemption.
VIOLATIONS
NOTICE VIOLATIONS
Withholding material information or submitting false or
misleading information.
Failure to file an exemption notice when other exemption condi-
tions are met.*
Late notice.
(*Fajlure to file a notice when other exemption conditions are
not met is a PMN violation rather than an exemption violation.)
o EXPOSURE LIMITS
Exceeds exposure limits, as determined by EPA’s monitoring.
Exceeds exposure limits, as reflected by company’s records.
Failure to take steps to limit exposure.
0 MONITORING
Failure to monitor.
Failure to monitor properly, e.g., unsuitable sample methods,
incorrect intervals, improper location.
0 E ’iGINEERING CONTROLS & EXPOSURE SAFEGUARDS
‘1o engineering controls and exposure safeguards used where
required.
Inadequate engineering controls and exposure safeguards used
where requt red.
No labeling where required.
Improper or incomplete labeling where required.
o RESPIRATORY PROTECTION
Proper respirators not provided for individuals in Special
-------
—5—
Production Area (SPA).
Respirators not worn by individuals in SPA.
uantitative fit test not performed.
o TRAINING
No training program.
Not all required individuals attend.
Inadequate/incomplete training program.
o HYGIENE
Appropriate facilities for changing and washup not provided.
Food, beverages, tobacco products, or cosmetics allowed in
SPA.
Inappropriate standards of hygiene which do not limit exposure.
o WORK PRACTICES
Improper spill/release control.
‘dritten procedures for responding to emergency situations not
mmediately accessibl.e to employees in SPA.
Materials for emergency situations not immediately accessible
to emoloyees in SPA.
Practices do not limit exposure to appropriate level.
Spills or unanticipated releases of a wet mixture not controlled
by trained personnel wearing appropri ate protective clothing and
equi pment.
o PERSONAL PROTECTION DEVICES
imp roper clothing or equi pnient.
CAUTION SIGNS
No signs.
Improper signs.
0 ENVIRONMENTAL RELEASE AND WASTE TREATMENT
Waste not handled as hazardous waste.
iastewater or discharge not pretreated.
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—6—
Wastewater or discharge not properly pretreated.
Process emissions not vented through appropriate control
devices.
0 RECORDKEEPING
Records not kept.
Records incomplete.
o RECORDS SUBMISSION
Records not submitted.
Records not submitted on time.
o PROHIBITION
Prohibition violated.
0 AMENDMENTS
Violation of an amendment.
There have been no amendments at this time.
INSPECTIONS
Neutral Administrative Inspection Scheme
All sites where chemicals are being manufactured/processed
or records are kept under this exemption will be inspected on a
periodic basis. The Region should inspect each site after an
initial exemption notice is submitted for that site, preferably
within 120 days after the notice is submitted. If no violations
are found, the Region should inspect again approximately one year
from the date of the first inspection. If no violations are
found during the second inspection, then the Region should re—
inspect each site approximately every two years.
If vio lations are found, the Region should reinspect the site
within 120 days. This should continue until two consecutive inspec-
tions are conducted and no violations are found. After that, the
Region should inspect the site approximately every two years.
Inspections may also be conducted at other companies/sites
based on tips or referrals.
Scheduling Inspections
Prior to scheduling inspections, the Region should contact
the company to discuss when the exempt chemicals will be manu—
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—7—
factured, where the records are kept, and a time frame as to
when EPA could Inspect. A specific Inspection date need not
be arranged with the company. Unannounced inspections are
onsidered desirable to assure compliance with this exemption.
ADMINISTRATIVE CONSIDERATIONS
Allocation of Responsibilities
Office of Toxic Substances
The Office of Toxic Substances will:
1. Review the exemption notices.
2. Have the Management Support Division make two copies of
the exemption notice and other relevant information,
including the name and phone number of the Notice Review
Manager and a statement of any OTS questions or concerns,
and notify the Document Control Officer In the Pesti-
cides and Toxic Substances Enforcement Division (PTSED)
within 15 working days after receipt of an exemption
notice that the documents are available.
3. Have the Notice Review Branch provide the Management
Support Division with the information referenced in #2.
4. Provide technical support .to PTSED and to the Regions
when needed via PTSEDS
5. Designate a contact person(s) to participate at PTSED’s
request in the review of inspection reports or case
files involving possible violations of the exemption.
6. Provide expert witnesses as needed.
Pesticides and Toxic Substances Enforcement Division (PISED )
The Pesticides and Toxic Substances Enforcement Division will:
1. Forward copies of the exemption notices to the Regions
including technical information relevant to the individual
notices and any 01$ concerns.
2. Provide technical support to the Regions, including guidance
for conducting Inspections and coordinating with OTS and
the Office of Legal and Enforcement Counsel (OLEC) to
resolve technical or legal questions.
3. Review inspection reports and keep OTS Informed regarding
compliance with the exemption regulation.
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-8—
4. Revid concur on civil cases prepared by the Regions.
Thisudes forwarding the cases for concurrence to OLEC
as red.
5. Coorie other TSCA §5 inspectIonal activities with
this ram.
6. Arramr expert witnesses.
7. Make mendat1ons to 01$ regarding amendments, repeal,
or prition of use of the exemption.
Regions
The Regio,ji :
1. Conta e company after receiving a copy of the exemp-
tion n:e from PTSED to determine when the exempt
chemic 4 jll be manufactured, where the records are
kept, •a time frame for inspection.
2. Scheduinspections based on the neutral administrative
inspect scheme in this strategy.
3. Performie inspections and gather evidence.
4. Send a irtesy copy of the inspection report to the
Compliai Monitoring Branch of PTSED.
5. Prepare sultant civil cases and litigate such cases.
(Criminacases are to be handled according to guidance
issued bOLEC concerning TSCA criminal cases.)
frogram Integrati
During an I ti n to determine compliance with the exemption,
the Inspector shoud also inspect for compliance with other TSCA §5
requirem 5 Prfr to conducting an inspection to verify compliance
with the exemption the Region should contact PTSED regarding other
TSCA §5 submfssjon ’actIvjtjes of the company.
Through the coTpliance monitoring activities related to the
enforcement of TSCAS5, the inspector may obtain compliance monitor-
ing Information Inv)lving other EPA enforcement programs. For
example, an fnspect ,, may turn up violations relating to other
parts of TSCA or of the water, air, or solid waste pollution control
regulatj 0 5 Thus, it is important for all those involved in
Section 5 enforcement to communicate non—Section 5 compliance
flOflitoring Information to the appropriate office in EPA.
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TABLE I
INFORMATION REQUIRED IN THE EXEMPTION NOTICE
1. NAME OF MANUFACTURER — S723.175(l)(1)(1)
2. SITES AND LOCATIONS WHERE THE SUBSTANCE WILL BE MANUFACTURED
AND PROCESSED — S723.175(i)(1)(i)
3. CHEMICAL IDENTITY — §723.175(i)(1)(ii)
4. IDENTITY OF IMPURITIES REASONABLY ANTICIPATED
§723.175(i)(1)Hifl
5. DESCRIPTION OF PHYSICAL AND CHEMICAL PROPERTIES
§723.175(i) (1) (iv)
6. IDENTITY OF BY—PRODUCTS AND VOLUME OF EACH — §723.175(i)(1)(v)
7. ESTIMATE OF ANTICIPATED MAXIMUM ANNUAL PRODUCTION VOLUME
723. 17Sf i ) (1) (vi)
8. ALL INFORMATION AND TEST DATA ON THE NEW CHEMICAL SUBSTANCE’S
HEALTH AND ENVIRONMENTAL EFFECTS THAT ARE KNOWN TO OR REASON-
ABLY ASCERTAINABLE BY THE MANUFACTURER — §723.175(i)(1)(vii)
IDENTITY AND DESCRIPTION OF THE ARTICLE THAT WILL CONTAIN THE
THE NEW SUBSTANCE - S723.175(f)(1)(viii)
10. DESCRIPTION OF METHODS USED TO CONTROL AND TREAT WASIEWATER
OR DISCHARGE RELEASED TO A POTW OR OTHER RECEIVING BODY OF
WATER. IDENTITY OF P01W OR OTHER RECEIVING BODY OF WATER.
5723.175(i)(1)(ix)
11. CERTIFICATION THAT THE MANUFACTURER IS FAMILIAR WITH AND
WILL COMPLY WITH THE TERMS OF THE EXEMPTION — §723.175(i)(1)(x)
ACRONYMS USED IN TABLES
POTW - Publicly Owned Treatment Works
TWA - Time Weighted Average
SPA - Special Production Area
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REQUIRUIENTS 10
[ 11
LIMiT EXPOSURE
I
I SPECIAL PRODUCTION AREA
I (SPA)
I
I
AREA ADJACENT
TO SPA
—— I
REMOVAL FOR I
STORAGE OR I
I
— I
PROCESSING WET I!IXTUR [ S I INCORPORATIOII
OUTSIDE SPA I INTO ARTICLES
I
I
I
POSURE Air Concentration — TWA
MITS I 10 ppm for gases and vapors
50 ug/m for particulates
Allowable TWA excursion of 50%
above for 30 mInutes or less.
S723.175(e)(1)
I
Must not ex— Must limit I
ceed limit for exposure. I
waiver of res— S723.175(e)(8)I
pirator protec
tion in SPA.
§723.175(e)(1O)I I
I I
I
I
Must take mea-
Sures to limit
exposure dur—
Ing operation
using engi-
neering con-
trols, train-
ing, hygiene,
work practice
and personal
protective
devices.
IIITORING* I t&ist monitor using suitable Periodic I
sample method. I monitoring same
When suit— Monitor first 3 eight-hour as for SPA in
able samp-I work shifts involving the areas where it
ling and I manufacture or processinng of is reasonable I
analytical each new chemical substance; to expect a
r9ethods then, 1 eight—hour shift per risk of Inhala—
exist. month during production run tion exposure.
during period of maximum em- S723.175(e)(10)I
ployee exposure. If In can- I
pliance for 3 months, monitor
only every 6 months unless
there Is a change in process, I
process design, or equipment I
(then begin monitoring again). I
Samples must represent worker’s I
breathing zone. I
S723.175(e)(3)(A) I
(See this section for details I
of monitoring.) I
- . I -
F F
I
p
- - - - - -. -. —-
-------
Respirator required for each
individual. Quantitative fit
test before first use.
Waiver if monitoring shows 8-
hr TWA of the new chemical
substance Is less than 1 ppm
for gases and vapors and 5
ug/m for particulates with
allowable TWA excursion above
for 30 mInutes or less.
TAIl I
REQUIREMENTS k. LIMIT EXPOSURE
I
I
I
I
I
I
•1
SPECIAL PRODUCTION AREA I AREA ADJACENT
(SPA) TO SPA
—I
REMOVAL FOR I
STORAGE OR
TRANSPORTATION
I
PROCESSING WET MIXTURES
OUTSIDE SPA
I___________________________
INCORPORATION
INTO ARTICLES
ITORING*
hen suit-
ble sanip-
Ing and
nalytical
ethods
‘o not
•x lst.
1
A surrogate chemical substance Same as for
possessing comparable physical SPA.
chemical properties under S723.175(e)
similar manufacturing and pro- (3)(B)
cessing must be used to assure
compliance with exposure I
limits. I
S723.175(e)(3)(B) I
I
I
I
I
I
I
I
I
I
I
I
I
I
______________________
I
I
I
I
I
I
I
I
I
I
I
INEERING Controls and safeguards must I
TROIS & I be used to ensure compliance I
OSURE with exxposure limits. I
EGUARDS S723.175(e)(4) I
I
I
I
I
I
I
I
I I
I I
I I
I
Labeling I
required. Must I
include ldentl-t
ty or code, I
statement of I
any known haz- I
ards, handling I
instructions, I
first aid
Infonnatlon,
spill control
directions, andi
DOT notations. I
S723.175(e)(9)
I
I
Must limit exposure, to I Controls and
the new chemical sub— I safeguards
stance. I must be used
S723.175(f)(1) I to limit
I exposure to
I the new chem-
I ical substance.
I S723.175(g)
I
:
P IRATORY
TECT ION*
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TABLE II
REQUIREMENTS TO LIMIT EXPOSURE
I SPECIAL PRODUCTION AREA AREA ADJACENT
I (SPA) I TO SPA
I
REMOVAL FOR
STORAGE 014
TRANSPORTAEION
I
PROCESSING WET MIXTURES I INCORPORATION
OUTSIDE SPA I INTO ARTICLES
I
I-
INING Required before employee can
)GRAM* enter. Must cover known phy— I
I sical-chemical and toxicolo- I
I gical properties of chemicals I
I handled In the SPA, proceduresi
I for using personal safegaurds,I
I hygiene, handling procedures,
I emergencies, and spills.
I S723.175(e)(5)(1)
I
Required for employees I
I handling wet mixtures. I
Must cover procedures for I
using personal exposure I
safeguards, hygiene, I
I handling procedures, I
I emergencies and spills. I
§723.175(f)(2)(I) I
IEPIE I Facilities for changing and
I washup must be provided. No
I food, beverages, tobacco pro-
I ducts, or cosmetics allowed
I In the Special Production
I Area.
S723.175(e)(5)(Ii)
•
Appropriate standards that
limit exposure must be
I used by employees handling
the wet mixtures.
S723.175(f)(2)(iI)
I
Hygiene must
limit expo-
sure.
S723.175(g)
4K Ilust be designed to ensure
CTICES compliance with exposure urn-
Its. Spills or unanticipated
I emissions must be controlled
I by trained personnel wearing
I suitable protective clothing
I or equipment, such as chemi-
I cal-resistant coveralls, pro—
I tective eyewear,and gloves.
I Written procudures and all
I materials necessary for emer—
I gency situations must be imme-
-I diately accessIble.
§723.175(e)(5)(1l1)
I I Must be designed to limit Work practices
exposure to the new chemi— must limit
I I Ical substance. Spills exposure.
I I or unanticipated releases S723.175(g)
I I must be controlled by I
trained personnel wearing I -
I protective clothing and, I
I where necessary, respira— I
I tors or chemically Imper— I
I vious clothing. I
S723.175(f)(2)( liI) I
I
I I
I
1ECORDS R RED TO BE MAINTAINED
-------
TAL3LE II
REQUIREMENTS To LIMIT EXPOSURE
I
I SPECIAL PRODUCTION AREA
I (SPA)
1
AREA ADJACENT
I TO SPA
REMOVAL 10k
STORA(E OR
TRANSPORTATION
——___________
PROCESSING WET MIXTURES
OUTSIDE SPA
INCORPORATION
INTO ARTICLES
I
ONAL Workers in the SPA must wear
ECTION suitable protective clothing
CES or equipment, such as chemi—
I cal-resistant coveralls, pro—
tective eyewear, and gloves,
I §723.175(e)(6)
I
I
.
I
I
1
Workers engaged In the Personal pro-
processing of wet mixtures tective de-
must wear suitable protec— vices must be
tive clothing or equlpment l used to limit
such as coveralls, protec—t exposure.
tive eyewear, respirators,I §723.175(g)
and gloves.
§723.175(f)(3)
ION Area must be clearly posted.
S I Sign must restrict entry to
I trained personnel equlped with
appropriate personal exposure
safeguards.
§723.175(e) (7)
I I
I
CORDS REQUIRED TO BE MAINTAINED
-------
TABLE III
ENVIRONMENTAL RELEASE AND WASTE TREATMENT
RELEASE TO LAND — S723.175(h)(1)
Process waste from manufacturing and processing operations In
the special production areas are considered hazardous waste
and must be handled in accordance with 40 CFR Parts 262
through 267 and Part 122 and Part 124.
° RELEASE TO WATER - S723.175(h)(2)
Wastewater or discharge must be pretreated before release to
a P01W or other receiving body of water. To release to a P01W,
pretreatment must prevent structural damage to, obstruction of,
or Interference with the operation of the POTW. For direct
release, treatment must be appropriate for the substance’s pro—
perti es.
RELEASE TO AIR — S723.175(h)(3)
All process emissions must be vented through appropriate control
devices.
-------
TABLE IV
RECORDKEEPING*
0 PRODUCTION RECORDS — S723.175(j)(1)Ci)
Annual Production Volume**
Date manufacture began
EXPOSURE MONITORING — §723.175(j)(1)(H)
Record of all monitoring Including:
Chemical identity
Date of monitoring
Actual monitoring data for each monitoring location and
sampling
Reference to or description of collection and analytic
techniques
If c anufacturer does not monitor, records of reasons for not
monitoring and the methods used to determine compliance with
exposure limits must be kept.
0 TRAINING AND EXPOSURE RECORDS — S723.175(i)(1)(iii)
Records of worker’s participation In required training.
Records to demonstrate regular use of personal exposure safe-
guards, Including results of personal exposure monitoring.
Results of quantitative fit test for respirator.
Any additional information related to worker’s exposure.
TREATMENT RECORDS — 723.175(j)(1)(iv)
Method of treatment if manufacturer releases treated wastewater
or discharge cbntainlng a new chemical substance to P01W or
receiving body of water.
*Records must be kept for 30 years following the final date of
manufaacture.
**Although not required to be kept by—the-regulatfon-, tnforma—
tion as to the estimated annual sales volume should also be
requested by the inspector.
-------
si
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
_____ WASHINGTON. D.C. 20460
\ /
OFFICE OF ENFORCEMENT
MEMORANDUM
SUBJECT: Inventory Enforcement Strategy
TO: Enforcement Division Directors
Air and Hazardous Materials Division Directors
Surveillance and Analysis Division Directors
Toxics Coordinators
Attached is the final strategy for enforcement of the
inventory reporting regulations. The strategy incorporates
continents received earlier from Headquarters and Regional
personnel. Major changes from the initial draft include a
more specific delineation of compliance monitoring priorities,
allocation of responsibility between Headquarters and the
Regions, and a revision of the civil penalty assessment pro-
cedure in accordance with the overall TSCA civil penalty
policy currently under development by contractor.
PTSED expects to have developed the first inspection
schedules for the Regions one month after the inventory is
published in June 1979.
A. E. Conroy4’ Director
Pesticides and ,To cic Substances
Enforcement’ Division
-------
IN/EN’1O RE1O I1sT REXtJtATIa 1S
F N L ENFOR E r STRAT Y
TABLE OF a) S1r TS
I. SuxTtT ry 1
II. Strategy Develcpi ent 2
A. Regulation 2
1. Objectives 2
2. ReguirelTents 2
3. Regulated Industry 5
4. Tin tab1e 6
B. Strategy Deve1c i nt 6
1. Objectives 6
2. Priority Violations 7
3. Canpliance 9
a. Voluntary Caupliance 9
b. Canpliance Monitorir 9
1) Tools 9
2) Application of Tools to Violations 10
3) Priority Activities 14
III. Strategy Implenentation 16
A. Program Management 16
1. Allocation of Res nsibility 16
2. Delegation of Authority - Confidentiality Clearance 20
B. Outread 20
C. Caupliance Monitorir Program 20
1. Confidentiality 20
2. Trainir 21
3. Ins ction Sites 21
4. Inspection for R & D Substances 21
5. Pcet Inspection Procedures 22
D. Enforceitent Proceediogs 22
1. Determination that a Violation Exists 22
2. Selection of Pr er Enforcement Action 23
3. Liability 24
4. Civil Penalty Asses ient Procedure 25
E. Program Integration 29
1. TSCA Programs 29
2. Other EPA Programs 30
-------
‘rAsr E OF ? TS
Data Sources Appendix A
Inspection Procedures APpendiX B
Violation Worksheet Appendix. C
Violation Citation Charges/Action Levels Appendix D
Evidence in Sup rt of Charges 1½pçendix E
Gravity Base Penalty Matrix Appendix F
Guidance for Use of TSCA
Civil Penalty Assessnent Worksheet Appendix G
TSCA Civil Penalty Assessnent Worksheet Appendix H
Federal Register Publicatons Appendix I
Sta itory Authority Appendix J
-------
IN 1E!T1O f REPORTI R U!ATICNS
FINAL ENFORCE ’EN! STRAT Y
I. Summary
Inventory reporting regulations were pronulgated under S8 (a) of
the xic Substances Control Act (TSCA) on Dece!rber 23, 1977. The
major objective of the regulations is to all , EPA to acquire information
necessary for the canpilation of an inventory of themical substances
currently marufactured, imported, or processed for a conmarcial purpose
in the U.S., as reguired by TSCA S8(b). An initial inventory based on
reoorts fran manifacturers of chemical substances and importers of chemical
substances in bulk will be published in May 1979. Thereafter, processors
of chemical substances and importers of chemical substances in mixtures
or articles will be given an port x ity to report any eligible substances
not included on the initial inventory. This information will be included
in the revised inventory, to be published in 1980.
Once the initial inventory is published, anyone wishing to tnaru—
facture a chemical substance or import in bulk any substance not on the
inventory must notify EPA at least 90 days in a3vance • Substances which
canpiete this premarufacture notification process and are martifactured
for a non-exempt purpose will be a3ded to the inventory.
This dooment contains the strategy of the Office of Enforc ent
(OE) for enforcing the inventory reporting regulations. It discusses
the regulation reguirenents, violations, priority canoliance noni toring
activities for FY79 and 80, case preparation and penalty assessrrent proce-
dures as well as the allocation of responsibilities bet een Hea3quarters
and the Regions.
Heedquarters will have the major responsibility for selecting subjects
for caupliance nonitoring while the Regions will be responsible for
conducting inspections and case preparation.
In FY79 OE will concentrate its major efforts on detecting reporting
of ibstartces excluded fran the inventory 1) because tnarufactured or
imrted solely for research and devel nt or 2) becaise not marufactured
or imported after Jaruary 1, 1975. OE will also attempt to identify persons
who failed to report for the initial inventory as r uired and whose
substances are being reported by processors during the revised inventory
reporting period. In FY80, after publication of the revised inventory,
OE will use its resources primarily to respond to reports of inventory
reporting violations.
* See definition in orooosed premarufacture notification requirErents
(44 FR 2242).
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—2—
II. Strategy Develop ent
P. Regulation
1. Objectives
The inventory reporting regulations prouulgated under §8(a)
of TSCA have o pdznary objectives.
First the regulations reuire information necessary for can-
pilation of the inventory of chemical. substances r uired by
TSCP §8(b). TSCA §8(b) r uires that the dTninistrator cuu 4le,
keep current and publish a list of chemical substances currently
marnifactured or processed for a iuuu rcial purpose in the U.S.
Since the term “man.ifacture” includes “to imt rt into the aistans
territory of the U.S.,” the inventory will also include chemical
substances imported for a ca ercial purpose. Any substance not
on the inventory is a “new” chemical substance • Under the §5
ptemartifacture notification r uirenent, a marufacturer of any
new chemical irust r tify EPA before he can marufacture it for a
non—exempt caim rcia1 purpose.
The inventory will be a contimally expanding list. The
initial inventory is extected to include over 95% of chemical
substances eligible for reporting. Publication of the initial
inventory will trigger premarufacture notification for manu-
facturers and importers of chemical substances in xilk. Sub-
stances which canpiete the premanifacture notification ocess
and are to be manufactured for a non-exempt ccinuercial purpose
will be added to the inventory. For a 210 day çeriod after
publication of the initial inventory, additional chemicals may
al be added to the list by proces rs, users and certain importers.
Secondly, under aut1 rity of TSCA §8(a)(l)(A), these regulations
reguire reporting of production and site information which is
reasonably necessary for establishing a profile of the chemical
industry, ironitoring chemical substances in the environn nt, and
setting Agency priorities for iznplenenting other provisions of
TSCA.
2. Requirenents
a. The initial inventory
Marufacturers and im rters had to report for the initial
inventory concerning all chemicals they marufactured or
ixroorted for a can rcial purpose in 1977 if (1) thirty par-
cent or Tiore, by weight, of the products marufactured or
inicorted consisted of the ty es described under Standard
Industrial Classification (SIC) Group 28 or 2911, or 2) the
total pounds of recortable ibstances equaled one million
unds or irore. In addition, marufacturers and im rters
had to report concerning any chemical that was marufactured
-------
—3—
at a single site or imported during 1977 in quantities greater
than 100,000 pounds. Caupenies whid fell within the criteria
had to report:
1) the identity of each themical substance,
2) for any polymer, the identity of at least thcse nona rs
used at greater than t o percent (by weight) in the maai—
facture of that polymer,
3) whether each substance reported was marufactured or
imported,
4) the site(s) where the substance was manifactured or
imported, whether the marufacture was site limited, and
5) the axrount (in broad ranges) mari.ifactured at each site
or imported during 1977.
Small marufacturers and importers did not have to report
iroduction volume or the site(s) where a substance was marti—
factured or imported. A marufacturer or irncorter qualified
for this exceotion if its total annual sales in 1977 were
less than $5 million. However, the range of production volume
of any substance produced in quantities greater than 100 ,000
pounds during 1977 had to be reported regardless of total
annual sales.
Persons riot required €o report for the inventory could,
nonetheless, report any substance they ha] martifactured or
imported for a caumercial purpose since Jan.iary 1, 1975.
avoid potential premarufacture notification, suth per ns
were responsible for ensuring that eligible then ica1s they
marufactured or imported were reported by sa eorie.
All information for the initial inventory had to be reported
by May 1, 1978 • On April 17, 1978, the Agency announced that
a marufacturer or in rter unable to meet this deadline because
of extenuating ciroimstances might be granted an extension
not to exceed June 1, 1978. -
Persons beginning marufacture or importation of a d Mca].
substance during the period between May 1, 1978 and the effective
date of the premarufacture notification requirements are required
to su nit an inventory report when marufacture or importation
begins.
-------
—4—
b. The revised inventory
Publication of the initial inventory will be followed be
publication of a revised inventory. Reporting for the revised
inventory is not mandatory. airing the 210 day reporting
i ricd, however, any eligible th nica1 substance not on the
initial inventory may be reported by those who (1) have pro-
cessed or used the thetnical for a camr rcial purpose since
Jaruary 1, 1975 or (2) have imported the d emica1 as part of
a mixture or article since January 1, 1975. (The latter persons
were also able to report for the initial inventory). Sudi
persons need only report diemica]. identity, polymer information,
and whether they import and/or process the substances reported.
They are encouraged, however, to report site and production
data as well. By reporting during this period, processors
and users will protect themselves fran prosecution under TSCA
515(2) for using a substance in violation of the pretnarufacture
notification requireti nts of §5. Importers of themical
substances as part of mixtures avoid ir through premaru—
facture notification by reporting during this period.
c. Reportir by trade associations or other agents
A trade association or other agent could not report for anyone
required to recort for the initial inventory.
A trade association could report for any of the following
persons:
1) anyone who has manufactured or imported a dietnical substance
for a caiu ercial purpose since January 1, 1975 and who was
not required to report for the initial inventory.
2) any processor or user of a theinical substance who chooses
to report for the revised inventory.
3) anyone who imports a themical substance as part of a
mixture or article and thooses to report for the revised
inven tory.
d. Prdiibited reporting
Certain substances may not be reported for either the initial
or revised inventory. These include:
1) chemicals which are manufactured or imported solely for
the purpose of researth and development (R & D). Chemical
quantities of less than 1,000 pounds/year are presumed to
be for research and development purposes.
2) chemicals not ‘narufactured, imported, or processed for
a ccumercial purpose since January 1, 1975.
-------
—5—
These substances include pesticides, tobacco products,
nuclear materials, firearms, and foods, drugs, cosmetics,
or medical devices.
4) mixtures.
In addition dieinicals which are not considered to have been
rnarufactured, imported, or processed for a camiercial purpose
se are excluded fran the inventory. Examples of such
chemicals are impurities, by—products which have no caimercial
purpose themselves, chemicals which are not intentionally r oved
from the eguipment in which they were manufactured, ar certain
other incidental chemicals (see 7].0.4(d)(3)—(8)).
e. Recordkeeping reguirenents
P11 persons who report under the inventory regulations must
keep records substantiating all information reported. In
addition, trade associations, in their capacity as agents for
persons subject to these regulations, nust keep records
ir icating which manufacturer, importer, or processor will
be able to doo rnent to EPA that reoorted chemicals were manu-
factured, imported, or processed since January 1, 1975.
f. Confidentiality
Manufacturers, importers, ar processors may claim any
item of revorted information to be confidential, including
the sçecific chemical identity. Confidentiality claims
must accompany the reported information ar must be sub-
stantiated by a signed certification statement. EPA will
not disclose a confidential chemical identity to irquiring
emical manufacturers unless they can show a bona fide
intent to manufacture the particular chemical (section 710.7(g)).
3. Regulated Indus y
A characterization of the chemical ir ustry performed for EPA
indiates that 10,000 manufacturers comprise the iniustrv. 150
of these firms with sales of $100 million acccunt for 80% of
irv3ustry sales.
There are no accurate figures available regarding the n.rnber
of importers subject to the inventory reportir raguireuents.
According to the American Imoorters Association, there are at
least 1200 brokers and up to 35,000 importers who might be
affected.
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4. Inventory Develc nent Tirret 1e
The fo11owii is a tixtetable of major dates in implerrentation
of the inventory. Related Federal Register ublications are listed
in Appendix J.
Dec. 23, 1977 Pramilgation of final inventory repqrtir
r uir rents
May 1, 1978 Deedline for subaission of forms for initial
inventory
June 1, 1978 Exterded deedline for suthission of reportir forms
May 1979 Publication of initial inventory
June 1979 Premarzifacture notification for marufacturers
and importers of themical substances in bulk
May 1979 Cauplete cauputer system (Informatics) operational
February 1980 Publication of revised inventory
Marth 1980 Preuiarufacture notification for impprters
of themica]. substances as oart of a mixture
B. Strategy Deve1q rent
1. Objectives
The major objectives of a prc ram for enforceuent of the inventory
re rting reguirerents are:
a. to help ensure the integrity of the inventory that it will
act as an effective guide for premarufacture notification
under TSCA §5.
b. to ensure the acairacy of prcxiuction arii site information
whith will be used by EPA to set priorities for implenenting
other sections of TSCA.
The inventory will be the sale basis for trigc rir the
premarufacture notification reguirerent under TSCA §5. The site
ard pr uction information reported, however, will probably
not be the only elerents used in the determination of priorities
for imolenenting other TSCA sect ions • Therefore, the Office of
Enforcenent will use its limited resources primarily to reath
the first objective.
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—7—
2. Priority Violations
Potential violations ranked in order of their concern to OE are:
a. reporting excluded substances
b. reporting false information
c. failure to report at all
d. failure to maintain records
e. failure to include all information
f. failure to report on titie
g. clerical errors
This strategy ranks each potential violation on the basis of the
econanic incentive for its cont iss ion, its impact on the imple—
mentation of §5 and, to a lesser degree, on its impact on the
abilities of the Agency to carry out effectively other objectives
of TSCA.
a. Reporting Substances Excluded fran the Inventory
Thirty days after publication of the initial inventory,
any person who wishes to marufacture or import in tulk a
d-iemical substance not on the inventory nust canply with
the premarufacture notification requirements of TSCA §5.
If a §4 testing rule is applicable to a new themical substance,
a person must have the required test data bsfore he can subuit
a premarufacture notice. In eddition subuiss ion of premanu—
facture notification may delay, limit, or pr thit production
of a substance under §5(e) or §5(f). A person would have a
major econanic incentive to report for the inventory any
themical substance he intends to manufacture or import in the
future to avoid S5 requirements.
R & D substances and substances not marufactured, imported
or processed since January 1, 1975 are excluded fran the
inventory by statute. Congress intended these substances to go
through the premarufacture notification process before being
manufactured or imported for a catmercial purpose. Substances
not o.irrently under the jurisdication of TSCA are also excluded.
(See II A.2.d .3) If these categories of substances (particularly
the former zo) are included in the inventory, the success of
the premarufacture notification process will be jeopardized.
Because of the great econanic incentive for imnitting this
violation and the great impact of the violation on §5
imoleiTentation, OE considers reporting excluded substances
the most immortant inventory violation.
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—8—
b. Re rting False Information
Sane persons may suixtit false data with respect to production
volune and whether the substance is distributed for cat nercia1
purposes outside the production site. The inventory reporting
regulations reguired reporting of production voluue only in
broad ranges. However, a alnpany might report a much lower
production volune to avoid public concern over the production
site of large quantities of potentially hazardous chemicals.
A substantially higher production volume might be reported
for R & D ch riicals or substances not marufactured since
January 1, 1975 to avoid pr narufacture notification reguirenients.
A u 3any miqht report that a substance is not site limited
to avoid prenerufacture notification which might be reguired if
later distribution outside the production site is covered by a
significant n i use rule. There is no major econanic incentive
for reporting false data aside fran that associated with
avoidance of pren arufacture notification. To the extent that
sut nissiori of false data would result in frustration of the
premarufacture notification process, it will be considered a
major violation.
TO the extent that submission of false data might impect
mplenentation of other TSCA provisions, it will be considered
a lesser violation.
c. Failure to Report at All -
Unless a person is certain someone else will report a substance
he manufactures or imports, there is little econanic incentive
for failing to report for the inventory. This is particularly
true since by reporting a person avoids the necessity for
prenenufacture notification.
Failure by a manufacturer or importer to report on chemical
substances as r uired will be considered a serious violation based
on its effect on the ability of the gency to carry out effectively
other sections of the Act. Failure to report a substance that has
not been reported by anyone will be considered a serious violation.
Failure to report a substance already included in the inventory
will be consider only a technical violation.
d. Failure to Maintain Records
Maru facturers, importers, processors and trade associations
are r uired to keep certain records as described in I .A.2 • e
above. There is no major econanic incentive for iui itting
this violation. Failure to keeo such records will result in
a presuntotion that information subnitted to the Agency is
inaccurate. Since the Agency Irust be able to rely on the
information submitted to carry out TSCA S5 as well as other
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—9—
sections of the Act, failure to maintain recotds rticularly
with respect to production yeats and use for a caiiiercial purpcee
will be nsidered a serious violation.
e. Failure to Include All Infotmation
Marufacturers and importers whose total anrual sales
exceed $5 million mist report on production oluma and whether
the temicals is site—limitated. There is no major ecortanic
incentive for camtitting this violation unless it is to hide
an excluded substance. To the degree that the anission could
affect the success of the pr narufacture notification program,
it will be considered a major violation.
f. Failure to Re rt on TiiT
There is no major econanic incentive for a failure to report
on tiiie. Although late reporting is preferable to failure to
report at all, it r nains a violation.
g. Clerical Errors, Internal Inconsistencies, Other Missing
Information
Reportir etLo of a clerical natire will not be the
target of enforce ent actions.
3. Canpliance
a. Voluntary Canpliance
An effective program aiited at informirq the affected industy
of the inventory reportir reguirenents was undertaken by the
Office of Industry Assistance. The general public would have
little interest in this regulation.
9ased on caiurtents received durirx the aiunent psriod for
the propceed regulations, national public interest groups
are well—informed of the requirenients. Any additional
attenpts to reach local interest groups should be confined
to discussion of the inventory as it relates to §5 require-
rtents.
5. Canpliartce Monitorir
1) Discovery Tools
Tools potentially available to A for disco iery of violations
of the inventory reportir regulations include the following:
a) inventory data
b) non—inventory data bases on marufacturers and importers
of themical substances
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— 10 —
C) reports of violations
o fran private irthviduals/canpanies
o fran other goverrircent agencies
o fran other EPA offices
d) on—site inspection/investigation
Of these, the on-site inspection/iiwestigatiori is the only
tool which can be relied on alone as the basis for filing a
camlaint. Generally, CE will have to rconitor compliance
with the inventory re rtir regulations by developing a
naitral inspection schedule based on ir ications of terttial
violation from the inventory itself, rar an selection fran
the inventory, outside allegations of violation arx irthcations
of violation discovered in the course of other TSCA or EPA
inspections.
2) Application of Tools to Specific Violations
a) Re rting Excluded Substances
i) R & D Substances
EPA may select persons for inspection because it suspects
them of havir re rted a substance marufactured or impDrted
solely for research arx1 devele i nt. Such a selection may
be made based on one or a combination of the fo1l ,iri tiethods:
o OTS will select fran the inventory any substances produced
or imported in quantities of less than 1000 lbs/year ar
retorted by known marufacturers or im rters of R & D
substances.
o rs will select fran the inventory those chemical substances
which were assigned new Chemical Abstract Service (CAS) numbers.
o CE will select fran the National Enforcercent Investigation
Center (NEIC) violation List (Ap ndix A) marufacturers
or ixn rters reportir for the inventory who have a
history of violating other EPA re rting or registration
reguir ients.
o Informatics will canpare the inventory with lists of
substances marufactured prior to 1977 (see International
rrede Canmission (Ix) ar Stanford Research Institite (Sn)
lists in ADpendix A) to is late substances appearing on
the inventory but not listed elsewhere as having been
marufactured prior to 1977. This nethod is of limited
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value for several reasons • There are no specific listirr s
for imported substances. Becaise the I’lC listing excludes
substances produced in quantities of less than 5000 lbs.
ar both ITC ar SRI listing are incomplete, a failure
to appear one either list may not ir icate a violation.
ii) Substances Not Marufactured, Processed, or Imported Since
Jaruary 1, 1975
To determine which substances reported for the inventory
might not have been marufactured or processed since 1975,
the inventory will be xmparai with I arx3 SRI data for
1975, 1976, ard 1977. Informatica will make this comparison
ard transfer the results through rs to the regions for
further investigation.
Since these lists are incomplete, substances isolated may
riot be in violation. A percentage of the manufacturers of
substances isolated, however, will be included in a regional
inspection s edule alor with a rardom selection of importers
who reporte:1 for the inventory.
iii) Chemical Substances Used Solely for Non-’rSCA Purposes
To isolate substances imprc er1y reported because they
are used solely for non-TSCA purposes, Informatics could
compare the inventory with lists of substances from Treasury
(tobacco and firearms), Nuclear Regulatory cat nissiori
(nuclear materials), FD (foods, drugs, cositetics) ard OPP
(pesticides).
Chemical substances used in products regulated by these
agencies may also have other uses appropriate for regulation
under TSCA. Therefore, EPA would have to cDrduct inspect ions
to verify whether substances isolated in this manner have
reportable uses. This approach consun s nore resources than
it erits given the potential rewards.
b) Reporting False Information
There are no complete or aco.irate .iblic data available
outside the inventory on production luTre per cthemical
substance or on site limitation. The only way to disco’ier
substantial variation from reported production ranges or false
reporting of site limitation is through books and records
i risiections. OE could include manufacturers, processors
ard imrorters in inspection schedules based on reports of
violation or random selections from the inventory.
C) Failure to RePort at All
The r1 st difficult violation to discower will be a
failure to report at all. Outside allegations of violation,
isolation of manufacturers or imrorters of chemical substances
reported for the revised inventory by users and processors,
and a comparison of inventory reports with available listings
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-12-
may yield sate suspects for inclusion in the inspection
sd edule. The available listir s, to the degree that they
are useful at all, can only indicate pcss ble violations.
Manufacturers
Manufacturers are listed by SIC code in the followir
canpi].ations (See Apçendix A):
i) 1)in and Bradstreet
ii) PrS/EIS
iii) OSHA
iv) PCS
Chemicals are listed by marufacturer in the followir can—
pilations:
i) SRI
ii) I
iii) ORD
None of these listirgs is cauplete and none makes a dis-
tinction between marufacturers and proces rs.
Failure to report by those who exceed the poundage
criteria will al be difficult to detect. The lists avail-
able for canuarative irposes (I , ORD, SRI) are incanplete
and generally indicate only production capacity not actual
production volune.
Sales figures are generally listed by chemical or diemical
gra.ip and not always by marufacturer (ITC, Dun and Bradstreet).
Although soma sales figures by manufacturer are included in
the ORD list, this information is incanplete and is limited
to 400 organics which are likely to be included in the inventory.
Imcorters
To brir diemicals into the U.S. after premarufacture
notification require rents go into effect importers rust sign
a certification indicatir that each imported diemical substance
is in canpliance with all TSCA require nts.
To determine whether importers have unlawfully failed to
re rt, EPA will rely on Custaus Inspactors to notify EPA
when entry forms do not contain the necessary certification.
Custans will hold the shiuient or release it under bard
until certification is verified. If the importer cannot
su ly docunentary proof of canpliance with inventory
requirements, the substance will be refused entry.
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—13—
T’bn-docunentary verification of the accuracy of
certification will be nore difficult. Actual sample analysis
of substances as a neans of verification is ex reive and
tine consumir unless the basic identity of the substances
is kn n. Samplinqjanalysis will be restricted to cases
presentir a stror suspicion of violation.
d) Failure to Maintain Records
This violation can be discovered only through on-site
inspactions.
e) Failure to Include All Information
isolate those marufacturers and importers wLo have
anitted site and production data and are in violation because
they have incorrectly described thenselves as small (total
anrual sales of less than $5 million), Infotmatics could
compare sales information in the Dun & Bradstreet and
PTS/EIS lists ainst information reported for the inventory.
Dun and Bradstreet and PrS/EIS list sales by marufacturer
and SIC code. A comparison might also be made with the
sales information for the 400 organica included in the ORD
list. All listings, h ever, are incomplete.
To isolate an otherwise small marufacturer or importer
who should have reported production and site information
for a particular substance becaise it was marufactured
or in rted in quantities of over 100,000 pounds, Inf or-
matics could compare inventory production information
with production capacity data on the SRI lists.
Since all marufacturers/importers are not included in
the available lists and the information included is not
reliable, QE would have to insçect a çercentaga of those
persons whose forms have missing information as well as
those about whom OE has received allegations of violation.
f) Failure to Report on Tine
OE will searth for marufacturers and importers
who failed to report as r uired and whose substances
are being reoorted by processors during the revised
inventory reporting pariod in the following manner:
1) o’rs will select a random nu rber of processors
reporting for the revised inventory and turn the list
over to OE for further investigation.
ii) OE will r uest from ead processor a certification
that he is not also a marufacturer of the substance.
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— 14 —
iii) If the proces r is not a manifacturer of the
substance, OE will reguest a list of the proces r’ s
suppliers.
iv) OE will contact each supplier and ask for certifi-
cation that he was not reguired to re rt for the initial
inventory Ci • e., substance was not man.i factured/ imported
after January 1, 1975)
v) OE will conduct a ra.itine records inspection of a
percentage of the suppliers identified.
vi) If CE finds an alleged violator, his nane
will be turned over to the Premarufacture Revie ,
Division at the sane tine case preparation is
begun to bring an enforcanent action for violation
of the inventory report ir regulations.
g) Clerical Errors, Internal Inconsistencies, Other
MisSir Information
Clerical errors, internal inconsistencies, or missirq
information sucth as signatures, names and a3dresses, prin-
cipal tethriical contacts, registry nurrbers, or EPA ccx3e
riunbers discovered on the form are being handled by the
Chemical bstract Service (C? S), which has contracted
for the responsibility of canpiling the inventory. When
such clerical mistakes are observed, C1 S will either
return the form or catununicate directly with the can ny
by letter. Should these rocedures be unsuccessful in
resolvinq the matter, the appropriate EPA Regional Office
coild be called in to assist. As indicated earlier,
reporting errors of a clerical nature will not be the target
of enforcement actions.
3. Priority Canpliance Monitorirq Activities
Since a major function of the inventory is to act as a trigger
for the premarufacture notification process, OE will place its
major emphasis on those wii .iliance mnitorin activities 1)
designed to insure the integrity of this function and 2) which
can reasonably be undertaken qiven available rescxirces (see
II.B.3.b.2)). With this purpose in mind, canpliance rronitoring
activities in order of priority are:
a) those designed to detect inclusion of R & D substances.
b) those desiqned to detect inclusion of substances not
marufactured since January 1, 1975.
c) those designed to detect failures to report on tine.
d) those conducted in res nse to reports of any of the
irwentory reoortirq violations.
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— 15 —
Subjects will be selected for ccsnpliance tionitorir on
the basis of the neutral inspection sch Tes described in
(II B.3.b.2)).
Thorough caupliance u nitorin3 prior to initial inventory
publication would ideally insure the integrity of the piblished
inventory as a §5 trigger ar prevent confusion resultir fran
p t publication deletions. Practically, OE can do little to
enforce the inventory prior to initial publication.
OE will cor iuct its inventory enforcenent program primarily
durir the period between publication of the initial inventory
and publication of the revised inventory.
The fol1 iir table ir icates the enphasis OE will place on
inventory re rtir caupliance nonitoring activities after
inventory publication.
% Allocation of Resources Available for Inventory Enforcement
I Stage
CM Activity % of Total Resources I
Affirmative CM for I
I
After Initial
R & D Substances
40%
I
Inventory
I
Publication
I
I
Affirmative CM for
Substances Not
30%
I
I
j
Man.ifactured or
I
I
Imported after 1975
I
I
Affirmative C l for
20%
I
I
for Late Su nissions
I
I
Responsive Cl to
I
I
Reports of Other
10%
I
I
Violations
I
I
Affirmative CM for
I
lAfter Revised
R & D Substances
I
l lnventory
I
IPublication
I.
I
Affirmative CM for
••I
I
Substances Not
I
I
Mari.ifactured or
I
I
After Imported 1975
I
I
Res ons ive CM to
I
I
ReT orts of Other
100%
I
I
Violations
I
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P. Pr ram Mana e Tent
1. Allocation of Responsibility
The folla iir table suxnnarizes the allocation of responsibility
for managelTent and implen ntation of the invent zy enforcenent pro-
gram.
Heaiquarters
PL’b L I OIS I ReqiOns
I I I I I
I R & D Substances I I I
I I I I I
I o Select Subjects I X I X I I
I I I I I
I o Notify Regions I X I I I
I I I I I
I o Conduct Inspections I I I X I
I I I I I
I 0 PrePare Cases I X I I I
I I I I
I Substances Not I I I
I Maru factured or Import I I I I
I Afterl975 I I I
I I I I I
o Select Subjects I X I X I I
I I I I I
I 0 Notify Regions I X I I I
I I I I I
I o Conduct Inspections I I x I
I I I I
oPrepareCases I I I X I
I I I
Reports of Violation I I I I
I I I I
I o Investigate Reports I X I X I X I
I I I I I
I o Conduct Inspections I I X I
I I I
I o Prepare Cases I X I
I Late Su nissions
I I I I . 1
I o Identify Subjects I X I X I I
I I I I I
I 0 Send Notices I X I I
I I I I I
I o Conduct Inspect ions I I X I
I I I I
I o Prepare Cases I I I X I
*He auarters will take over case preperation for R & D substances
where 1) more than one region is involved or 2) the B & D detetnd nation
is a canpiex one.
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— 17 —
The allocation of responsibilities illustrated in the table is
based on a) special expertise, ard ease of access to data, aid b)
resources r uired for a given activity cançared with C) resources
actually available.
a. Special Expertise arx] Ease of Access to Data
He quarters OE will be responsible for working with
OTS to select subjects for caupliance monitoring activities
becaise of the greater ease of access to inventory data
as well as other data reguirei in making the selections.
b • Resource reguir nts
Resources will be reguire3 for selecting subjects fran
inventory ard non—inventory data bases, for insçection/
investigation, aid case preparation as follows:
1) Selection of subjects
a) Inventory data
QE will use several approaches to select cardidates
for inspection fran data su nitted for the inventory:
i) 1 iring the revised inventory reporting period,
ars will forward to OE on a monthly basis a list
of processors who have reported. OE will through
the steps described in II 3. 3. b. 2) f) to determine
whether arty of the suppliers of the processors are
in violation of the inventory reporting reguirenents.
Selection of processors by OTS will reguire approxi-
mately 2 weeks. Further foll -up by OE Headquarters
prior to inspection by the Regions will reguire
approximately 2 weeks.
ii) Informatics One month after oublication of the
initial inventory, a canplex catiputer system will
be available to OE for selection of inspection
candidates. OE can reguest candidates based on any
of the peraneters reported for the inventory with a
turn around tine of 2 days.
b) Non—inventory data bases
Date available to OE outside of the inventory are
limited ard not extremely reliable. (See Appendix A
for description of data sources.) While there are a
number of listings of importers, there is rio canpre-
hensive listing of specific diemical substances by
int rter. Information on man.ifacturers is also poor
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ar makes no distinction bet een maaifacturers ard
processors. As a result, establishment of a cauplete,
reasonably acairate irdustry profile for cr.. arison
with the ilwentory reportir data is riot pcesible.
The limited data which are available axild be used as
a starting point in selecting manufacturers ard
importers for inclusion in an inspection schedule only
for select violations as indicated in (II. B. 3.b.2)).
CE can expect a torn around tine of 2 days to obtain
a list of inspection candidates from any non—inventory
data bese on c ]uputer tape ard available within EPA.
If a non-inventory canputer tape mist be c .au ired with
the inventory, it may take as long as t o weeks to
obtain results. If non—inventory data is available
only in bound form,the time reguired to obtain a cardi—
date list will be 2 days for inventory printout ard at
least 2 weeks by CE personnel or a contractor to make
the manual ccn parison.
2) Investigation/inspection
CE will have to investigate any substantive reports of
violation before instituting any eriforc rent action.
Resources r uired will range fran those r uired for
writing a letter to the alleged violator reguesting clari-
fication of the cirournstances to those reguired for an
on—site inspection.
The foll ’iir elements were considered to determine
resource r uirenents for establishment inspections:
o preparation time
o travel tine
o books arr3 records inspection
o inspection report preparation
Requir nts per inspection will vary with differences
in travel time, the canolexitv of the potential violation
being investigated, ard the experience of inspectors in
corducting this type of inspection. Given these variables,
PTSED feels that an average inspection will reuire 5 days.
3) Case Preparation
Case preparation will vary deDerdirq on whether a case is
settled or goes to a hearing. rs estimates that case pre-
caration through settlement will r uire 15 days while case
preparation through a hearing will r uire 15 days for write-
up ard 15 days for litigation (a total of 30 days.)
It is estimated that violations will be discovered in 10%
of the inspections corducted. Of the resulting cases, it
is estimated that 85% will be settled while 15% will g to
a hearing.
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d. Application of available resources to strategy
resource r uirET nts
Based on the fiqures contained in the preceding section
(III.A.l.b.) and the resources available in FY79 ar FY80,
the following calo.ilation can be made to swmlarize the sccpe
of the inventory reporting enforc nt program in FY79 arr3
FY80.
30 workdays Headquarters inspection schedule
develcpmant Fl 79
10 Workdays = Headquarters inspection schedule
develcpuent Fl 80
5 workdays = one inspection
220 workdays = one work year
4 workyears = resources available in FY79
3 workyears = resources available in FY80
x total rumber of inspections
.10 X ruirber of case preparations
( ,1 OX)(.85)(15) runiber of case preparations
for settlenent
(. IOX)(.15)(30)= rumber of case eparations
for hearing
1) 4 work years x 220 work days! work year = 880 workdays
2) 30 + 5X + 1.27X + .45X = 880 workdays
X = 126 inspections in FY79
1) 3 work years 220 workdays/workyear = 660 workdays
2) 10 + 5X + 1.27X + .45X = 660 workdays
X = 98 inspections in FY80
The inspections will be assigned to the Regions by Headquarters
based on the pattern revealed in the selection of subjects for
investigation. Regions will a1 be responsible for any case
preparation resulting fran the inspections. Regions s uld,
however, adhere to the Concurrence Procedures (See March 27, 1979
meno to Reqions) prior to proceeding with any case. These pro-
cedures are rticularly inwrtant to insure a consistent approach
in cases involving an R & D substance since the definition for
sudt a substance may be subject to varying interpretations.
In cases where classification of a substance as R & D is
genuinely open to dispute, eadquarters will take over the case.
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2 • Need for Delegation of P uthority arx Confidentiality
Clearance
All Regions have a.ithority to corthict ir8pections under TSCA.
Currently, hc ,ever, Regions do not have edeguate enforc nt
personnel cleared to access ard cc y confidential information
in the course of an inspection or to access confidential data
reported to EPA which may be necessary for edequate case pre-
peration. If sufficient Regional personnel do not receive con-
fidentiality clearances, the inspection ard case preparation
resporsibilites must shift to Heaiquarters.
B. Outreach
Heedquarters will be responsible for irnplen ntir Outreach as
described in II. B. 3. a.
C. Conpliance Monitorir Pr ram
Once OE has selected subjects for inpliance monitorirv, an
on—site inspection will be used as the mcet effective tool for
discoverir violations. Before the inspection pr ram can proceed,
the foll iing issues must be addressed:
1. Confidentiality
Because it is quite likely that instectors conductir
a §8(b) inspection will need to gain access to information
clained confidential, all irs ctors must have a security
clearance from the Office of Toxic Substances.
Ins ectors must be thoroughly familiar with procedures
in the TSCA Confidential Business Information Security Manual .
Confidential data reviewed ard collected as pert of an inspection
must be treated with the sane strict security neasures as con-
fidential data sutmitted to the Pgency under TSCA reportir
requirertents.
2. Trairiir
All TSCA inspectors should be familiar with basic principles
of diemistry. No advanced trainirtq in diemistry, however, is
necessary for cozx1uctir inspections related to inventory report ir
reguirenents.
Inspectors must be thoroughly familiar with the Inventory
Re rtirig Requlations, the Inventory Enforcement Strategy, and
the procedures for conductirq TSCA ins ections as ouliriad in the
P Insrector’ s Manual and Appendix C of this Strategy. There
will be no need for san le collection.
-------
— 21 —
3. Inspection Sites
Since it is likely that complete records will be kept at
corporate headquarters or a company’s major business office,
the initial inspection should be corducted . if necessary,
additional inspections may be r uired at specific produc-
tion sites.
4. Inspection for R & D Substances
Certain violations such as failure to maintain records
or reporting false production data may readily be detected
in a books ard records inspection. The determination that a
substance has been reported in violation of the R & D exclusion
will be acre difficult. A substance may be initially presumed
by EPA to be an R & D d-iemical because it is produced in
annual quantities of less than 1000 lbs. and there is no
other public information available to irdicate that it has
been produced for a catuiercial purpose. While a books ard
records inspection may not clearly rthit or affirm this
presumption, the foll ing considerations should be kept in
mirv3:
Pre—Revi sed Inventory Pub ii cation
o A marufacturer must be able to produce clear evidence
that a substance is used for cLiIut rcia1 purpose.
Sale of a substance is not enough alone to justify
its clasgification as a reportable substance in
catmercial use. A marufacturer must be able to pro-
duce, documentation such as letters fran customers
certifying that the chemical in question is being used
for purposes other than research ard development.
o A company must use consistent criteria for distinguishing
B & D from test market ard other cLlmI rcial substances.
EPA should honor these criteria as long as the canpany is
consistent in their application. A company may not, for
example, use one set of criteria to support inclusion of a
substance in the inventory ard another set to justify
exe!Ilption of a substance from premarufacture notification
requirements under S5(h)(3) of TSCA.
Post Revised Inventory Publication
After publication of the revised inventory, an additional
test may be used in conjunction with tests listed above
to determine whether a substance should be considered an R
& D substance. A substance produced in small quantities,
even if sold, will be considered an R & D substance if
used under the direction of a technically qualified
jrdividual. A person who because of his training, educa-
tion or experience 1) is able to aopreciate the health &
safety ascects of the substances used under his supervision;
-------
— 22 —
2) is res nsthle for enforcing tiethods of scientific
experitientat ion, analysis, or chemical research to
minimize such risks and 3) is responsible for safety
assessitents and clearances related to the prooiresent,
storage, use and disposal of the chemical substance as
required by the scope of the R & D activity is considered
a technically qualified individual. A great degree of
control by the manifacturer and a great degree of technical
qualification on the part of those handling or supervising
the use of a substance will distinguish a substance
held to be for R & D from one considered to be for a
cannercial purpose other than R & D.
5. Post Inspection Procedures
After each inspection, the inspector shall write an
Inspection Report based upon information on the Violation
Worksheet (Appendix C) and his Field Notes. The inspec-
tion Report shall detail all violations thith the inspector
telieves he found during the inspection and shall describe
all relevant supporting evidence. After completing the
Inspection Report, he shall suthtit that do ment, the Vio-
lation Worksheet, a c y of his aDplicable Field Notes and
other relevant supporting doa.ments to the case preoaration
officer. The inspector shall keep the original Field Notes
in his files and shall keep on file copies of all other material
sent to the case preparation officer.
0. Enforceient Proceedings
Regional enforcenent officials shall examine each Inspection
Report and any other relevant material su nitted by the inspector
and make the following determinations:
1, Is there a probable violation?
2. If so, what type of enforcenent action, if any, should
be brouqnt?
3. Against whan should the enforcenent action be brought?
4. If the enforcement action is one for administrative
civil oenalty assessnent, how iuch should the proposed
civil penalty be?
Guidelines for making each of these determinations are
provided below:
1. Determination that a Violation Exists
Each failure by a person to comply with a specific inventory
reporting requirement for a single chemical substance shall
constitute a se rate violation. ‘I C determine whether a probable
-------
— 23 —
violation exists, the case preparation officer shall consult the
Violation Citation Charges (Appendix D) and Evidence in Support
of Charges (Appendix E) and cai pare then with all the evidence
provided in the Inspector’s Report. The case preparation officer
may determine that there is insufficient evidence to support a
violation d arge. If additional evidence can be obtained
without unreasonably intensive efforts and the violation if
substantiated is not insignificant, the case preparation officer
should ensure that steps are taken to remedy any evidentiary
deficiencies.
If the case preparation officer determines that the avail-
able evidence will support a violation diarge, he/she will
transmit the material to the Regional enforcenent attorney who
will determine what enforcemant action should be brought against
the alleqed violator.
2. Selection of Prcper Enforcenent Action
The Agency may bring a rumber of enforcenent actions
against an alleged violator. The Agency may:
a) issue a notice of non—canpliance
b) assess an edministrative civil penalty
C) institute a civil court action
d) institute a criminal court action
‘1 determine what general level of enforcenent action would
be appr riate for the violation standir alone, the enforcenent
attorney shall consult the Violation Charges/Action Levels (Appendix
0) and Evidence in Support of Charges (Appendix E). Thereafter,
the enforcenent attorney shall determine what specific enforcenent
action should be selected by cons iderir the foll ir criteria.
Notice of Non—caupliance
A notice of non-caupliance may be issued where:
1) the violation does not impede the Agency’s ability to
enforce the premarufacture notification requirenent,
2) the violation affects the accuracy of the diemical
profile established by the inventory but is not
criticial to EPA’s ability to detect other violations.
3) the violation is the first violation of the inventory
reportir regulations, and
4) the violation does not appear to have been willful.
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— 24 —
A notice of rcn-canpliance s u1d be Issued only if the
enforcenent attorney determines in his/her discretion that
the violation passes these tests and that the issuance of a
notice of non-canpliance will be sufficient to induce the
violator to cease violation of the regulation in those
respects stated in the riot ice of non-canpliance.
Administrative Civil Penalty
Mcet violations will be handled by administrative civil
penalty assessed accoLding to the procedure outlined in III.
D. 4 below.
Civil Court Action
A civil court action for injunctive relief may be brought
against the alleged violator in lieu of or in addition to assess-
mant of an administrative civil penalty, if the alleged violator
ignores the civil penalty.
Criminal Court Action
Cr ininal action will be rec 1u!ended only if the alleged
violator has willfully or knowingly reported an excluded sub-
stance with the knowledge that the substance, because of its toxic
properties, would probably be controlled under the pren anufacture
not if ication systen.
3. Liability
The Inventory Reporting Regulations define “persons”
to include individuals as well as corporations, parther—
ships or associations. In taking enforcettent action to
redress violations of thGse regulations, therefore, EPA
generally has the option of proceeding against the business
entity alleged to be in violation and/or against the
responsible official who signs the reporting certification
or who would be responsible for doing so.
Generally, EPA will hold only the corporation liable
for the actions of its officers and en ployees. The Agency,
however, reserves its right to impose individual liability
under appropriate ciraimstances. If EPA brings an actiot 1
against a rtnership or an unincorporated association, the
partners/utenibers will, of course, be jointly and severally
liable. (Dpending on whether the “entity” or “aggregate”
theory of parthership prevails in a given state, EPA will
have to name the partnership or the parthers to ensure the
validity of its canplaint.)
In an action against a totally or partially owned
subsidiary, EPA may join any parent canpanv whi plays
a substantial role in the business affairs of the subsidiary.
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— 25 —
4. Civil Penalty Assessment Procedure
a. Threshold decision and complaint
Once the enforcement attorney has determined that a civil
penalty is warranted, he/she must prepare a c r.iuplaint setting
forth the appropriate charges as listed in Appendix D and
propose to assess a civil penalty which is the sum of the
independently assessable charges contained in the complaint.
b. Independently Assessable Charge
A separate civil penalty shall be assessed only for
each violation of the inventory reporting regulations
which results from an independent act (or failure to
act) of the respondent and which is substantially dis-
tinguishable from any other charge in the complaint.
A given charge is independent and substantially dis-
tinguishable from any other charge for the purpose of
assessing separate penalties if each provision requires
an element of proof not required by the other. Thus
not every charge which may appear in the nplaint
will be separately assessed. For example, a man.ifacturer
may falsely report a large pr uction volume to hide the
fact that he is reporting an R & D substance for the
inventory. He would be charged with t o violations:
reporting false information and reporting an excludable
R & D substance. H ever, since the second charge gr s
out of the first, the mamfacturer would be assessed a
civil penalty only for reporting an excludable substance.
c. Civil Penalty Asses nt System
k civil penalty system for use by EPA in implementing
TSCA is currently being developed under contract. The
civil penalty assessment system is composed of t o elements:
A Gravity Base Penalty (GBP) which provides a iteth of
assigning penalties to violations based on their seriousness;
and P justnent Procedures which provide a method of edjusting
the Gravity Base Penalty to account for mitigating and/or
exacerbating factors related to the violator.
Under this system violations of TSCA have been grouped
into o major categories: control violations—those
involving mishandling of a regulated chemical substance and
data gathering violations—those involving failure to adhere
to a monitoring, recording or reporting regulation. Data
qathering violations have further been divided into those
associated with a regulation controlling a chemical sub-
stance and those not associated with a control regulation.
The latter are aimed at develooirg information needed to
assess the threat of a new or existing chemical substance.
-------
— 26 —
Violations of the Inventory Reportir Regulations
f all into the categry of non—associated data gatherir
violations. The rerall TSCA penalty system has been
developed ar in 1 violations of regulations of a thenical
substance aid Trust be edapted sanewhat to accann date
violations of non—associated data gatherir regulations,
The basic structure aid guidelines, however, do prou ide
the reguired approath.
i) Gravity Base Penalty
The major ncdification of the o ,erall TSCA civil
penalty assessment system to suit inventory re rtirtg
violations ocairs in the assignment of the GBP.
Generally EPA will use a Gravity Base Penalty Matrix
(Apperdix F) to determine the GBP an unt for a vio-
lation of TSCA. OE has itodified this GBP matrix in
two respects to accx miodate the inventory reportir
regulations.
Penalty ancunts in the GBP matrix have been
assigned based on the seriaisness of the violation.
Two parameters are used to established the severity
of a violation: extent of damage and potential that
damage will ocair • For inventory report ir violations
the extent of the violation defined by the section
of TSCA affected aid the tential damage by the
potential that the violation will seria.isly affect
implementation/ enforcement of the TSCA section.
In eddition the GBP matrix has been nodified to
eliminate as inapplicable the “Significant” level
from the “Extent of Damage” indicator and the “Mid—
rarpe” level fran the “Potential Damage” irdicator.
The following is a description of the measures of
“extent” aid “potential” for violations of inventory
reportirp regulations.
/ TE r/
Major — A major violation is one that affects the
oreman.ifacture notification requirements.
Minor — A minor violation is one that caild affect
sections of TSCA other than §5.
/ rE rIAW
Hiqh Range — The violation directly affects EP’s
ability to enforce or impl ient a TSCA
r uirBffent.
La..i Range — The violation results in a lack of
data which is important but not critical
to TSCA enforcement or implementation
procedures.
-------
— 27 —
Based on ns ideration of the abocTe-mantioned
factors the foll iing GBP’s are suggested for eath of
of the potential inventory report ir violations. (See
Ap ndix D for potential action levels in dition to a
c .iu laint.)
o Report ir Excluded Substances:
Extent of Damage
Major - The report affects the Pgency’ $ pr arufacture
notification re uireuents.
Potential for Damage
High — If an excluded substance is reported for
the irwentory, EPA will not be able to
implement or enforce the §5 r uir ents
with res ct to the substance.
= $25,000
o Reportir False Information:
Extent of Damage
Major - The false information affects the
pr aru facture notification r uirei nts.
Minor — The false information affects sections
of TSCA other than §5.
Potential for Damage
E igh — The false information results in the
inclusion of an excluded substance and
thereby affects EP A ’s ability to enforce
or iinplenent §5.
— The false information results in lack of
data used to select d emicals for further
stidy.
GBP
Major/nigh — The CBP will be assessed under the
violation for reporting an excludes
substance. No seDarate GBP will
be assessed for false reportirg.
Minor/L — $250
-------
— 28 —
o Failure to Report
Extent of Damage
Major - The failure to r ort affects impleu ntation
of S5 becaise the substance has been
r orted by no one.
Minor — The failure to report potentially affects
only imolementation of other sect iors
of TSCA becaise the substance was reported
by u one else.
Potential for Damage
High — It may result in needless pre-
marufacture notification by other
marufacturers.
— It results in a lack of data for use
in selection of cheiiicals for further
study.
GBP
Major,4!igh — $25,000
Minor/Lw — $250
o Failure to Maintain Records
Extent of Damage
Major — The failure to maintain records for
production years and use for a
caiui rcial purpose c ild affect
implenentation of section 5.
Minor — The failure to maintain records cQlld
affect implei entation of TSC sections
other than section 5.
Potential Damage
High - The lack of production arr] catniercial
use records cannot be ccm 1 ensated by
other information to substantiate
re1 rtirt of a non—excluded substance.
— In most cases lack of records can be can—
ensated with other information and will
result only in a lack of substantiation
for data ‘ hith is important but not critical
to selection of substances for further
control.
-------
-29-
GBP
Major/High — The GBP will be assessed under the
violation for reporting an excluded
substance • No separate GBP will be
assessed for failure to maintain records.
Minor/Lw — $250
o Failure to Include All Information
Extent of Damage
Major — The failure affects pr arufacture notification.
Minor — The failure affects sections of TSCA other
than §5.
Potential Damage
High — The failure results in inclusion of an
excluded substance.
Low — The failure results in a lack of data
affecting selection of substances for-
further control.
G B?
Major / High — The GB? will be assessed under the
violation for reporting an excluded
substance. No separate GB? will be
assessed for failure to include all
information.
Minor/L j — $250
o Failure to Report in Time
Failure to report on time will be considered
under o tine frames — before initial inventory
publication and after initial inventory publication. .
efore Initial Inventory Publication
No GBP
Untimely reportir theoretically affects the
integrity of the inventory as a basis for pre-
n rtifacture notification. In fact, however, as
long as re rts were received in tine to be included
in the initial inventory, the Agency will be able to
implement §5 proç.erly.
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— 30 —
After Initial Inventory Publication
After initial inventory piblication, the violation
autatatically thanqes to Failure to Report and sho.ild
be handled under those guidelines.
o Clerical Errors
EPA will take no enforcemant action against
i ere clerical errors.
ii) Adjus tents Factors
All the rules and procedures presented in the
overall TSCA Penalty Policy for aijustiTents sha..ild be
applied to the GBP for inventory reportir violations.
d. Canputation of the Civil Penalty
Day of Violation Defined Since the inventory reportir
regulations establish specific deadlines for canpliance, the
duration of any violation disco iered caild be canputed fran
the deadline of the date of canpliance. Suth an approath,
however, waild result in unduly harsh cenalties. Therefore,
for purooses of ca1 uting the civil penalty for an inventory
reoorting violation, the day of violation will include only
the day of discovery.
e. Worksheet
The Civil Penalty As ssnent Worksheet (Appendix H) shall
be used to caupute the pr osed civil penal and to record
any subsequent aijustn nt to the prcposed anount. The
Worksheet serves as a guide to the Agency in arriving at
a final civil penalty, and as a menorarduin of the Agency’ s
deliberations concerning the violations cited • The Worksheet
need not be sent to the respondent as part of the canolaint
but sh ild be made available to him u n r uest. Detailed
instructions for xinputirg the prcposed penalty and canpletir
the Worksheet appear in Appendix G.
E. Prc ram Integration
1 • TSCA Programs
a. Impact of Violation
Only two violations will have a major direct impact on
other TSCA implen ntat ion and enforcenent orograrns. Reporting
of an excluded substance or a failure to report at all will
impact i.molenentation and enforceuent of the §5 prenian.ifacture
notification regui ents.
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— 31 —
b. Communication Med anism
1) The Regions will notify OE Headquarters of potential
enforcement actions for either of the above-uention
vioiations through the Cono.irrence Procedures.
2) If OE Headquarters concurs in the action, it will
notify OTS of the pendertcy of the action and will confer
with cyrs to c termine whether the circimstances of the
alleqed violation warrant:
a) premariifacture notification including
a halt to production for 90 days and a
civil penalty for violating the inventory
reporting reguir ents, or
b) premarufacture notification with no
halt in production and a civil penalty, or
C) premarufacture notification with or
without a halt to production and a notice of
non-compliance
d) a civil penalty.
3) OE will notify OTs of the outcome of the
enforcement proceeding.
4) A reported substance which was excluded fran the
inventory .it whith is being marufactured or imported
at the time the violation is discovered is subject
to the prem rufacture notification reguirenerits as is an
eliqible substance for which no report was su nitted to
EPA. When prexnarufacture notification is reguired, OE
Headquarters will theck with rs to ensure that §5
procedures have been initiated by the violator.
5) A person who reported an excluded substance bit is
not marufacturing/importing it at the tine the violation
iS discovered will face a civil penalty and renoval of
the substance from the inventory. OE/OrS will announce
renoval of the substance through a Federal Register notice.
2, Other EPA Programs
Information reported under the inventory reporting regula-
tions may aid other EPA enforcement programs in their compliance
rr nitoring activities. With the exception of the discovery
of an unreported substance, which might be of interest to
the Water Permits Program, information discovered through
inventory compliance rionitoring activities will be of little
value to other EPA enforcement programs.
-------
APtoIDIX A—i
IwrA )ul(a-S Suinnery
fist inct ion
Marulacturer Ps oces5or
Mane i Mdress Marufacturer
D t a
S ( iice
L*n ani
ir.IJstLy
A5 lstance
iiuprter
LIBtinCJ
by
L.istirq
by
Lnstkq
by
I.tatiiq by
Oieslcai
Lietirq
theinical
Proluction
voluiie/
Mane & address
SIC Code
CAS
I
themical
Grcup
Gt ip
Capacity
to
l’ota l Sa ies/
Previc*is
to
yes
no
no
yes
to
to
to
gross
sales
to
yes
to
yes
to
to
to
no
to
f K)
to
to
to
1PZ
yes
no
to
to
no
inccatplete
yes
yea
by dtemlcal or
d einical t TOJ)
to
by dienical or
dneuical groip
(not by mamjtactui-er)
Oil)
to
to
to
yes
400 orqantre
no
to
inort let
inoamplete
inoanpiete
to
O 5 A
yes
to
to
yes
no
to
to
no
so
to
to
n
rls/F: IS
yes
so
to
- yes
so
to
to
tO
to
yes
to
no
tpi
yes
to
to
to
yea
10,000
to
to
so
to
so
so
i,iIC Vs.lation
I.i t
yes
to
to
yes
so
so
to
to
to
so
no
O,ctrn s
Ikireaus rsis
m
to
to
to
so
so
by
Qjstons
rcglon
yes
broad
categories
to
to
no
to
general
cat ecories
of iwprts
only
so
no
to
to
NI. Imprters
Asss. ni rectory
no
to
1200 brokecs
iu sorter s
to
to
no
general
categories
of Import.
only
Ite .ilster of
Au. Iu lx)rtecs
&Ex urtent
to
no
35,000
to
so
so
general
oatupOriee
of lituports
only
general
categories
of Irports
only
no
no
no
s
-------
A-2
Duta Sources
Maw facturers/Chemic&. Substances
Name
Subject Cove raqe
Coveraqe
Date
Update
Frequency
Availability
Conii nts
International Trade
Ccininission (ITC)
“Synthetic Orqanic
Chemicals — U.S.
production ard
Sales”
• U.S. finns by SIC code
• qross sales
maw facturers
importers
trade associations
law firms, consultants
etc.
41,000 entries
danes tic production (by
oriqinal marufacturers
only) arid sales of
synthetic organic
chemicals and raw mate-
rials fran /nidi they
are made
qenerally mininurn pro-
duct ion voluma reported
is 5,000 lbs.
minimum sales value is
$5,000
items 1 i sted by primary
maw facturer
alphabetical listing of
reporti rrj marufacturers
and their a:ldresses
data supplied by 800
producers
.
van able EPP/OPE
Steve Weil
755—2770
Hani copy in
EPA Library
Canputer
access through
Steve Heller
0PW54938
• no distinction
between maw—
facturer/pro-
cessor
• no production
figures
• no listing by
chemical sub-
stance
data not reg-
ularly updated
& often inaccurate
based on D&S, write-
ins, etc
no production,
or SIC data
statistics for
chemical or group
are given only when
there are 3 or nore
producers arid there is
no possibility of
violating confiden-
tiality
all marufacturers are
not listed by d emi—
cal substance
.
sales,
S
Dun & Bradstreet
1859—present
industry Assistance .
contirual Office of
.
List
.
.
.
Industry
Assistance
Joe Boyle
755—3852
.
1916—present anwal - - -
-------
A-
Maw facturers/Chemical Substances
Name
Subject Coveraqe
Coveraqe
Date
Update
Frequency
bility Conmants
Old)
Orqanic Chemical
Producers Data
Base
• 400 organic d emicals
listed by CAS II
may include:
• total themical
production & prices
• site specific pro-
duct ion capacity
• nama ani address of all
[ inns inspected
• 4 diqit SIC codes
• ranked by injury severity
• U.S. firms with nore than u
employees, annual sales over
$500,000
• 4 digit SIC codes
. sales by plant in category
county by county
market share
117,000 citations
variable Cincinnati
IERE ,
Dave Becker
(8) 684—4481
OSHA
Susan Nelsn
Office of
Ik 1icy ar i
Analysis
Integration &
Evaluation
Roan 4605 or
jack Katalinas
Head, Mqmt.
Info. System
Pm. 3700
523—7115
contain
product
every
• does not
ociuple te
slate for
plant
• inorganic
voluma of
d emicals
addressed
data is not uni-
formly available
for all listings
will probably be on
inventory
no information on
production or sales
no distinction
between maw facturers
ar*i processors
• no distinction
between mariifacturers &
processors
no breakdcivjn by
specific themical
substance
no production volun
• no sales data per
d emical substance
variable
OSIIA—Industry List
& small
specialty
are not
variable
PUS1EIS PLants
rev 1 sed
quarterly
i’ir j L
Dc iq Sebe
(8) 234—5306
-------
Marti facture rs/Chemical Substances
Update
Frecluencv
Coverage
Date
Name
Subject coveraqe
Availability Cc*mients
OPE
Stanford Researdi
.
10,000 diemicals
annual
Judy Nel n • no distinction
Institute (SRI)
•
IMrufacturers
(1977)
between manufacturer
&
“Directory of
•
production capacity
Betty Jthn n
proces r
Chemical
(415) 326—6200
• no actual production
Producers”
X—68627
availability
only in
hardback
‘volune
• no sales information
-------
A-S
Importers/Cheuni cal Substances
Update
Frequency
anrual
Cove raqe
nate
Name
Subject coverage
Availability
Ccni ents
Customs Bureau
.
listirirj by broad
Available but . no listirq by
TSIJS
.
dieunical categories
(T JS #)
regional figures on
import volume ard
price
no ready access themical sub-
because of stance
confidentiality . no listin j by
considerations marufacturer
. no sales figures
by marufacturer
or diemical Sub-
stance
1 ji rican Importers
.
1200 neir iers-brokers
anrual
available P SED . lists only general
T s ciation
importers
Tad R an AN
categories of
Directory
(212) 490—2723
inports
American Importers
anl Exporters
35,000 names
. inaccurate
1974 ed. in . listirq only by
Directory
library
PTSED has on order
general categories
i.e., ferilizers
-------
A-6
Substances Not Regulated (Jnler TSCA
cove rage tJpda te
Date Frequency
airrent
Name
S
bject Covered
Availability
Conn ents
OPP/E1 A
.
.
registered pesticides
name
registrants
Elqin Fry
Paul Cassy
69430
need active
ingredients,
not products
Food
Ralph Strard
245—1567
Drugs
Winston Cobb
427—8171
air rent
-------
A-7
EPA Violation Inforn tion
Coverage
Pate
LJprla te
Frequency
NEIC List
Listirrj of violators of
other EPA reqs. by SIC
code
current
NEIC—Denver
I uq Seba
workirq on cauprehen—
sive listirq available
to PL’SFD for select ion
of firms for inspection
schedule
Name
Subject Coveraqe
Availability
Ccim ents
Air Cciinpltance
Violations listed by:
Data
System
. point source
• SIC code
• county
1972—present
variable
Stationary
Source
Enforcement
.
no distinction
between marufacturers
& processors
Division I-Iq’s
Frank Smith
755—0103
PCS
. facility locations for
permit holders
• SIC code
• permit information
variable
Water
Enforcement
Bill Milliqan
755—0991
•
no violations listed
PEMS
• manufacturers by estm.
• by state
• by violation
It
1974—present
variable
FrSED
-------
A-fl
Mdttional Information Sources
Coverage update
Date Frequency
Name Subject Coverage
Availability
Ccii.nents
Census Bureau
not available
PI 1 SED
to
Confidential
Interstate Cc*iunerce
Commission
not available
1”I’SED
to
Confidential
-------
fl)LX B—i
Violation :
Reporting Substances Excluded from the Inventory
R&D Substances
flequlatory Requ ireinents
I nspect ion Procedure
Documentation
S710 .4 ( c) (3 )
Any them i cal substance ma ru factured,
processed, or imported solely in small
quantities for research and development
as defined in § 71 O. 2 (y) is excluded
from the inventory.
§710.2(y )
Small quantities for research and
development are defined as:
1) quantities of a substance no greater
than reasonably necessary for purposes of:
• scientific experimentation on;
• analysis on;
• diemical researdi on;
• analysis of;
• any research or analysis for the
development of a product;
2) quantities used by or directly under
the supervision of a technically
qualified individual after publication
of the revised inventory.
There is a presumption that products
maw facturerl, imported or processed in
quantities of less than 1000 lbs. are
for R&D purposes.
A person report inq a substance produced
in such quantities has the birden of
certifying that it is not for R&D.
• Ask for the canpany’s criteria for
determining whether a diemical subs-
tance is to be classified for R&D.
• Ask what specific procedures are
in lved in developing a test market-
ing prcxjram for chemical substance.
Ask for canpany documentation in
support of non — R&D classification
for this particular d-meintcal substance
Ask to see production records for
the chemical éubstance from the first
year of production.
Ask to see sales records for the
chemical substance from the first
year sales tock place.
• Ask to see records listing biyers.
Ask Co to produce correspondence
fran customers denons trat i rr that
the substances has been cannercially
distributed or is in test marketing
r* ase.
• Make copy of written criteria.
If written criteria are not avail-
able, obtain a statement from a
responsible official cutlining the
criteria and attesting to their use
by the canpany.
Make a copy of written procedures.
• If no written procedures are avail-
able, obtain a statement fran a
responsible official outlining the
procedures and attesting to their
use by the canpany.
Make a copy of any documentation
If no documentation is available,
obtain a statement fran a re-
sponsible official outlining
specific support for the canpany’s
classification of the substance.
Make a cxpy of production records.
Make a notation in the field book
of production records which
available.
Make a ocpy of sales reords.
• Make a notation in the field bod
of sales records which are not
available.
Make a copy of names, addresses
and pbone withers for later veri-
fication of the quantity of the
chemical substance sold and the use
of the chemical substance by the
tziyer.
-------
13— —
R&D continued
Regulatory Hequireinents
Inspect ion Procedures
Doaimentat ion
• Ask to see records indicating size
ar 1 wither of production site(s) for
the chemical substance.
Ask to see records indicating the in-
ternal use to which the chemical is
put if not sold.
• Ask to see any aivertisinents regardirg
the use of the substance.
• Ask abait the educational backgrourwl
a l l 1 present professional duties of
any person in charge of use or
distribution of the substance.
(after publication of revtsed
inventory)
Make a cc y of available records.
• Make a notation of obsetvat ions
in the field book if any on—site
visit is make.
• Make a ccpy of available records.
• Obtain an affidavit certifyinçj
this use from a responsible
conpany official.
• Make a c y of any alvertiseinents.
• Make a notation in the field
book if no alvertisemants are
available.
• Obtain a statesent from a
responsible canpany official
as well as the person in
of the use or distri-
bution of the substance at—
testinj to that person’s
education and professional
responsibilities.
-------
Violation :
Reçortirq Substances Excluded from the Inventory
Substances Not Manufactured, Processed, or Imported Since January 11, 1975
Requlatory Requirements
§710.4
Inspection Procedure
Documentation
Any chemical substance not manufactured,
processed or imported for a canmercial
purpose since January 1, 1975 is
excluded from the inventory
• Ask to see production recot:ds or (for
importers) purd- ase records for the
d emical substance fran 1975—1977.
• Make a copy of available records.
• Make a notation in the field book
of periods for which there are no
sudi records.
• Ask to see sales records for the
themical substance fran 1975—1977.
• Ask to see records listirrj buyers of
the themical substance fran 1975—1977.
• Ask to see records of use if the
c* emical substance is not sold.
Ask to see aivertisenents reqardirq
sale or use of the substance fran
1975—1977.
• Make a copy of available records.
• Make a notation in the field book
if there are no sales records.
• Make a copy of names, addresses,
ard telephone ruirbers for yen-
ficiation of the year and the
au unt of the sale.
• Make a copy of records indicating
internal use.
• Obtain a statement certifyinj
internal use from a responsible
canpany official.
Make a ccpy of advertisements.
Make a notation in the field book
if no copies of advertisements
exist.
-------
B-4
Violation :
Reporting Substances Excluded From the Inventory
Chemical Substances Regulated Under Other Acts
Requlation Requirements
Inspection Procedure
DoQimentat ion
§710.4(c) (1)
Any substance not considered a “chemical
substance” as provided in subsection
3(2)B of TSCA and in the definition of
“chemical substances” in §710.2(h) is
excluded from the inventory.
§710.2(h) “Chemical substance” does not
include:
(I) Any pesticide when marufactured,
processed or ciistrthuted in canmerce
as a pesticide.
(2) ‘lt*acco or any tobacco prcxluct, but
not including any derivative products.
(3) Any source material, special nuclear
material, or by product material.
(4) Any food, food additive, drug,
cosmetic, or device, when marufactured,
processed, or distributed in canmerce
for use as a food, food additive, drug,
cosmetic or device.
Ask to see records substantiating
a use that does not fall into the
excluded cateqori es.
• I’ .sk to see advertisements regard irq the
non—excluded use of the substance.
Ask to see records listing buyers who
use the substance for a non—excluded
purpose and correspondence denons tratirq
use by buyers for non—excluded purpose.
Ask to see sales records for non—
excluded uses as well as excluded
uses.
Ask to see production records
• Make a c y of the records
. Obtain a statement certifying
the use from a responsible
cci pany official.
. Make a cqy of any advertisements.
. Make a notation in the field
book if no sud advertisements
are available.
• Make a copy of addresses aid
pbone ruthers for later veri-
fication of the non-excluded
use.
. Make a copy of the records
. Make a notation in the field book
if information is not available.
Make a copy of any records dis-
tinguishing between anounts of the
chemical substance produced for
excluded aid non-excluded uses.
Make a notation in the field
book if the information is not
available.
-------
Violation :
Reportir False Information
(Proluct ion Volume/Site Limitation)
Requ La tory Requirements
§7 10 .5
I nspect ion Procedure
Doaimentat ion
Manufacturers and importers (other than
sinai! manufacturers or importers) who
are required to report must report in
addition to:
• the identity of the d emical
SUbStance
• rionoi rs used at qreater than
2% (by weiqht) in the manufacture of
the polymer; and
• whether the substances reported are
inarufactured/iinported (initial in—
ventory) or imported/processed
(revised inventory),
• the site(s) where the substance is
manufactured/imported and for manu-
facturers and processors whether such
activity is site specific ,
• Ask to see records irdicatirrj the
number and size of poduction sites
• Ask to see product ion recoi x1s for the
themical substance fran 1975—1977.
• Ask to see sales records for 1975—1977
• Ask to see a list of buyers.
• Make a cx y of available records
If records are not available,
make notation of this in the
field book.
• Make copy of records.
Caupare this information with data
irriicatir j the wither and size
of iroduction sites to check for
disparities.
• Make a copy of the records.
• If they are not available, note
this in the field book.
• Make a copy of names, addresses
and pbone numbers for later
verification of sales.
• the auount manufactured
at each site or imported
dLlrinq 1977 .
If yw suspect that an R&D chemical has
been reported follo.i the alditional
procedures cutlined in 13—1,2.
-------
Violation : Failure to fle nrt At Mi
Requ la tory Requ i reiients
Inspection Procedure
Documentation
§710.3(a)
[ Xiue tic mawfacturers and impOLi-ers
nust report for the initial inventory
concecninj all chemicals they marufacture
or iuqort for a canitercial purpose in
1977 if:
1) 30% or iirre, by weiqht, of the pro-
ducts they maw facture or import cxrnsist
of the types described under Standard
Inriustrial Classification (SIC) Groups
28 or 2911, or
2) the total pounds of reportable
substances eiual one million pounds or
nnre per site for marufacturers
(even if not in SIC 28 or 2911)
3) the chemical substance was maru—
factured or imported in quantities
qreater than 100,000 pounds.
§710.3(c)
Processors and users of a chemical
substance for a ocimnercial purpose
are not subject to initial inventory
requi rements.
• Ask to see records supportinj failure
to report
• Ask to see product ion records
for all substances maw facturel
in 1977.
• Ask to see records of total anount of
chemical substances imported in 1977.
• Make a ccj y of any records
• Make a notation in the field
book of any recoards not avail—
able.
• Make a cc(y of records in-
dicating that 30% by weight
of the chenical substances
are in SIC code 28 and 2911.
• Make a ccçy of records indicat-
ing total reportable dieinical
substances maw factured or im-
ported is one million pounds or
nore.
• Make a copy of records irdicatirig
that any chemical substance is
marufactured or imported in
quantities greater than 100,000
pounds.
• Make a notation in the field
book if any of the above
mantionec] records are not
available.
-------
D-7
Violation : Failure to Maintain Records
Requ 1 a tory Reclu i rements
I nspect ion Procedure
Documentation
§710. 1(c)
Each person wIx reports under these
regulations shall maintain records that
document information reported under these
regulations and, in accordance with the
Act, 1 nait access to and the ccpyirq of
such records by EPA officials.
• Ask to see records substantiating
all information reguired to be
reported for a chemical substance
• identity
• nonouers used at greater than
2% (by weiqht) in the
marufacture of any polymar
whether maru factured, pro-
cessed or imported.
• production site(s)
• whether site—limited
anount marufacturel at
each site or imported
durtrrj 1977.
• Make copies of substantiating
information.
Make a note in the field book of
any records not maintained.
-------
B—U
Violation : i?ailure tO Report All Required Information
RequL a tory Requiren nts
Inspection Procedure
floornentat ion
Initial Inventory
§7 10.3(a)(l)
• Ask to see total sales figures for 1977
• Make a ccpy of records.
If reconis are not avail-
able, make a notation in
the field book.
Any person who manifactured diemical
substances in 1977 must report:
1.) All diemical substances at each site
for which 30% or nore by weiqht fall into
SIC Group 28 or 2911.
2) All theinical substances at eadi site
where one million pounds or gore were
mar*i factured.
3) Any chemical substance inarutactured
at a site in quantities greater
than 100,000 lbs.
. Ask to see 1977 product ion recoids for
eadi suspect product.
Make a ccpy of the recotds
If they are not available, make
a notation to this effect in the
field book.
§710 .3 (a) (2)
Any person who imported diemical
substances in 1977 must report;
1) All diemical substances for which
30% or uore by weight fall into SIC
Group 28 or 2911.
2) All diemical substances imported
as part of a total of one million
pounds.
3) Any chemical substance imported
in quantities greater than 100,000 lbs.
-------
13—9
Violation; Failure to Report All Ilejuired Information
Regulation Requiremants Inspection Procedure D C X mei tation
§710.5
Manufacturers and importers required to
report must report:
1) the identity of the themical substance,
2) those ononers used at greater than
2% (by weiqht) in the manufacture of a
polym r,
3) whether the substance is manufactured
or ilnprted
Manufacturers must also report:
1) the site at whith the substance is
mariufact ired arvl whether the themical
substance is mari.ifactureti only within
a site.
2) the annunt of the themical substance
manufactured at ead- site.
Importers must report the total anount
of theiuical substance imported.
§7 10 .5 (a) (3)
Any small importer or manufacturer
(total annual sales of canpany, parent—
conpany, and all canpanies owned or
controflerl by the parent together are
less than $5 million) is exempt fran
reportinq production voluma (for
quantities less than 100,000 pounds)
and site information.
-------
Ap r ix C-i
Inventory Re rtir Regulations
ReCamTerr3ed Fo Tiat
Establishi ent Inspection checklist
Date
Narre of Facility
T .in ar Br street *
Location
Phone Number
Inspector
er ns Contacted:
Name Title tione Number
-------
C—2
Record Maintenance (1977)
Chemical Identity
Mona rs used at greater
than 2% (by weight) in
the marufacture of a
polymer.
Chemical Substance is
Marufactured
processed
Intp rted
Production
30% by weight in SIC Groip 28 or 2911
Total
Per Chemical Substance
Sales
Total
Per Cherctial Substance
IDistributiori
Use
Internal (Site—limited)
External
Advertisements
Production Site(s)
Size
Number
Criteria for R&D Substances
Criteria for test marketing substances
Qualifications ard res nsibi1ities of the
r n in d arge of production & die-
tribution of a d-iemical substance
later revised inventory publication
-------
Appendix D-1
Citation Charges and Action Levels for Violations of the
Inventory Reportir Regulations Pranulgated Under Section 8(a) of
the Toxic Substances Cont o1 Act
PERSON FAILED ‘10 MPLY WITH THE P VISIONS OF THE INVE! 7rORY RE DRTTh REQUIR 1ENTS
PItt4ULGAT ) UNT R SECTION 8(a) OF THE ‘IOXIC SU TN4 S 1P L ACT IN THP THE PERSON:
Al. Failed to report concernir a d emica1 substance manufactured in the U.S.
for a cam ercial purpose durir 1977 as reguired becaise 30% or itore by
weight of the products manufactured are described by Standard Indus ial
Classification (SIC) Group 28 or 2911. (42 FR S710.3(a)(l)(i)(A))
Action Level: C nplaint and/or
Pr nanufacture Notification RequirE!ent
A2. Failed to report concerninq a d emica1 substance manufactured in the
U.S • for a uaercial purpose durirq 1977 as r uired because the total
pounds of reportable theutical substances manufactured at that site
equals one million pounds or more.
(42 FR S710.3(a)(l)(i)(B))
Action Level: Canolaint and/or
Preinarnifacture Notification R uiren rtt
A3 • Failed to re rt concerninq a d emica1 substance manufactured in the U.S.
for a c iui rcial purpose durirq 1977 as r uired because manufactured at
a site in quantities ual to or greater than 100,000 pounds.
(42 FR §710.3(a)(l)(ii))
Action Level: Canplairtt and/or
Premaaifacture Notification Requi r tent
A4. Failed to report concerning a emical substance imported into the U.S.
for a ca rical purpose because 30% or more of the products imported
are described by Standard Industrial Classification (SIC) Group 28
or 2911. (42 FR §710.3(a)(2)(l)(i)(A))
Action Level: Canplaint and/or
Premanufacture Notification R uireTent
P5. Failed to report concerning a themical substance impDrted into the U.S.
for a catuercial purpose durir 1977 as reguired because the total pounds
of reportable themical substances inported uals one million pounds or
more. (42 FR S710.3(a)(2)(i)(B))
Action Level: Canplatht and/or
Preinaaifacture Notification RequireiTent
-------
D—2
A6. Failed to report concerning a themical substance imported into the
u.s. for a ccmi rcia1 purpose durir 1977 as r uired because imported
in quantities equal to or greater than 100,000 pounds.
(42 FR S710.3(a)(2)(i)(B))
Action Level: Ccmiplaint and/or
Pr narnifacture Notification quir nt
7. Failed to report a d emical substance by the May 1, L978 deed line
without an extension (42 FR §710.6(a))
Action Level: Notice of Non-canpliance or
Canplairtt and/or Premanufacture
Motif icat ion R uir nt
AB. Failed to report the site at which he manufactured the thenical sub-
as r uired for all but small manufacturers. (42 FR §710.5(d) (2))
Action Level: Notice of Non—c npliance or
Canplaint
P9. Failed to report the business eddress at which he ixn rted the
themical substance as r uired for all but small importers (42 FR
§710.5(d) (2))
Action Level: Notice of Non-c npliance or
Cauplaint
AlO. Failed to report the antunt of the d emical substance which he marufac-
tured at eath site for whith reportir g was r uired in 1977.
(42 FR S7].0.5(d)(4))
Action Level: Notice of Non-canpliance or
Cauplaint
All. Failed to rwort the anount of the themical substance which he iin rted
durir 1977. (42 FR §7l0.5(d)4)).
Action Level: Notice of Non-canpliance or
Ca laint
Al2. Failed to report that marufacture of the themical substance is site limited.
(42 FR §710.5(d)(3)
Action Level: Notice of Non-canpliance or
Canplaint
AU. Falsely reported the anount of the themical substance manufactured
at any site durir 1977. (42 FR §710.5(d) (4))
Action Level: Notice of Non-caupliance or
Canplaint
-------
D—3
A14. Falsely reported the ancunt of the themical substance imported
durir 1977. (42 FR S710.5(d)(4))
Action Level: Notice of Non-compliance or
Complaint
A15. Reported a emical substance excluded fran the inventory because
marufactured lely in small quantities for researth ar develop-
uent. (42 FR §710 .4(c) (3)).
Action Level: Notice of Non-compliance or
Canolaint ar 3/or
Preniarufacture Notification R uireient
A16. Re rted a themical substance excluded from the inventory because
imported soley in small quantities for researd ard develcpmarit.
(42 FR §710.4(c)(3))
Action Level: Notice of Non-compliance or
Complaint and/or
Premarufacture Notification R uirE1ent
A17. Reported a &aemical substance excluded from the inventory because
processed, solely in small quantities for researth ard develop—
mant. (42 FR S710.4(c)(3))
Action Level: Notice of Non—compliance or
CanpLaint
A18. Reported a themical substance excluded from the inventory
because not marufactured, for a c u i rcial purpose January 1,
1975. (42 FR §710 .4(c) (4))
Action Level: Notice of Non—compliance or
Complaint ard/or
Premanufacture Notification Re uirenent
A19. Reported a themical substance excluded from the revised inventory
because not processed for a commercial purpose since January 1,
1975. (42 FR S710.4(c)(4))
Action Level: Notice of Non-compliance or
Complaint
p20. Reoorted a themical substance excluded fran the inventory because
not imt rted for a commercial purpose since January 1, 1975.
(42 FR §710.4(c) (4))
Action Level: Notice of Non-compliance or
Complaint ard/or
Premaru facture Not if icat ion R uiren nt
-------
D-4
A21. Re rted a themical substance excluded from the inventory becaise
requlated under the Federal Insecticide, E ngicide and denticide Act.
(42 FR §710.4(c) (1))
Action Level: Notice of Non-compliance
22. Reçcrted a themical substance excluded from the inventory becaise
regulated under the Federal Food, Drug aid Cosne tic Act.
(42 FR S710.4(c)(1))
Action Level: Notice of Non-compliance
A23. Failed to maintain records that doament information re rted
under the regulations (42 FR §710.1(c))
Action Level: Notice of Non-compliance or
Complaint
A24. After beir presented with a warrant, failed to permit cess to
records that doQinent infornation re rted under the regulations.
(42 FR S710.l(c))
Action Level: Complaint
A25. After bsing presented with a warrant, failed to a11a4 EPA officials
to ccpv records that doc.nrent infornation repDrted under the
regulations. (42 FR §710(c))
Action Level: Canplaint
-------
E—2
Sales/distribution records ir icate that less was produced than was
reported. There are no other records indicating on—site (non-
sales) use to u len nt the sales figures.
A14. Purchase records show higher figures than those reported .
Purchase records st z lower figures than those reported.
Sales/distribution records show higher figures than those reported.
Sales/distribution records show lower figures than those reported.
A15. Evidence may vary fran canpany to canpany. Generally a violation
can be supported if a cxxnpany is inconsistent in fornuilating
criteria defining an R&D substance for §8(b) and §5(h)(3).
The following factors which alone would not be sufficient to indicate
a violation may create a stronger presumption when considered together.
Before publication of the revised inventory:
• The substance is marufactured in quantities of less
than 1,000 pounds.
• The substance is sold but purchasers cannot corroborate
ca uiercial use.
The substance is not sold, and there is no record of
use in any process resulting in another ccnirercial
product.
After publication of the revised inventory:
The substance, whether or not sold, is used by or unc r
the direct supervision of a technically qualified individual
who is concerned with evaluating the physical chemical,
and performance tharacteristics of the substances.
A16. Evidence may vary fran canpany to canpany. Generally a vio-
lation can be supported if a canparty is inconsistent in
formulating criteria defining an R&D substance for §8(b) and
§5(h) (3).
The following factors, which alone would not be sufficient to
indicate a violation, may create a stronger presumption
when cons iciered ta ether:
Before publication of the revised inventory:
The substance is imported in quantities of less than
1,000 ounds
The importer has no records to substantiate that the
final user uses the substance for catm rcial purpose
or uses it in a process resulting in another camiercial
product.
-------
E—3
After publication of the revised inventory:
The importer has no records to substantiate that
the substance is not used by or under the direct su r-
visiOn of a tethnically qualified ir ividual who is.
concerned with evaluating the physical, themical, and
performance tharacteristics of the substance.
A17 • Evidence may vary fran canpany to canpany. Generally a violation
can be supported if a cunpany is inconsistent in formulating
criteria defining an R&D substance for S8(b) ar §5(h).
The followinq factors, which alone would not be sufficient to
indicate a violation, may create a stronger presumption
when considered toqether:
Before publication of revised inventory:
The substance is processed in quantities of less
than 1,000 pourx s.
• The substance is not sold, ar there is no record of
use in any process resulting in another catmarcial
product.
After .iblication of revised inventory:
• The substance, whether or not sold, is used by or under
the direct supervision of a tethnically qualified
individual who is concerned with evaluating the physical,
thernical, ar performance tharacteristics of the substance.
A18. Other data sources show the substance has not been man.ifactured
since Jaaiary 1, 1975.
Canpany production records show no evidence of marufacture
since January 1, 1975.
Canpany sales/distribution records show no evidence of sales
since January 1, 1975.
Reputed buyers fail to corroborate ircthase.
Cattpany records show no evidence of internal use.
Al9 • Other data sources show the substance has not been processed since
January 1, 1975.
Canpany production records show no evidence of processing since
January 1. 1975.
CanDanv sales/distribution records show no evidence of
sales since January 1, 1975.
Reoorted buyers fail to corroborate urthase.
-------
E—4
CQltpany records show no evidence of internal use.
A20. Other data xirces show the substance was not imçxxted
since January 1, 1975.
Canpany production records show no evidence of importing
since January 1, 1975.
Canpany sales/distribution records show no evidence of
sales since January 1, 1975.
Reputed buyers fail to corroborate purthase.
Canpany records show no evidence of internal use.
A21. Substance has a use requlated under FIFRA and there is no
evidence of another current use for the substance in advertise-.
merits sales/distribution or other canpany records.
A22. Substance has a use regulated under FF A and there is no
evidence of another current use for the substance in vertise—
rients sales/distribution or other canpany records.
A23. No records are available to substantiate claims upon raitine
inspection. ffidavit from inSpector at ests to this fact.
A24. Affidavit fran insrector attests to the refusal by the person
to permit access to records after being presented with a search
warrant and informed that such refusal is a violation of the Act.
A25. Affidavit fran inspector attests to the refusal by the per n
to allow him to c y records u n presentation of a search
Jarrant.
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APPENDIX F—i
( AVITY BASE PENALTY MATRDC
Extent of Damage
I
1 MPJOR
I I
IPotential thati High 25,000 I
iDamage will Range 20,000
locair T
I 5,000
I Range I 2,000 I
MINOR
I
5,000
3,000
I
I
I
500
250
I
I
I
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Appendix G—I
Guidance for Computation of Civil Penalties Using the
TSCA Civil Penalty Assessmant Worksheet
Scope
The ISCA Civil Penalty Assessn nt Worksheet is to be used to upite
the penalty which the Agency proposes to assess against any violator who
is subject to the civil penalty sanctions of the Act and any subsequent
TTodifications or edjust!Ents of the proposed penalty. The Worksheet
also serves as an office record of the case and as a menorandum of the
gency’ s deliberations concerning the penalties proposed and finally
assessed for the violations cited.
Gravity Base Penalty
(1) List the “Q arge Code Number” as indicated under column headed
“Charge Code”. Such charge code run’bers mist conform to the charge as
written in the complaint.
(2) List each “primary” charge in the sane order as it appears in
the complaint. A charge which represents an independent act (or failure
to act) and which is substantially distir uishable fran any other charge
shall be considered to be a “primary” charge and shall be independently
assessed.
(3) List each “Lesser included charge” (Any charge which appears
in the complaint but which does not arise from independent acts and
which is riot substantially distir uishable fran another previaisly
cited charge). No independent penalty shall be assessed for such a
charge.
(4) The “penalty base fiqure”, which corresponds to each “primary”
charge entered in Item (2) shall be taken from the appropriate cell
of the Gravity Base Penalty (GBP) Matrix.
(5) Review the “history of prior violations”. If an adjusbient
is in order, consult the “Table of Adjustient Factors — History” and
the accani anyirq guidance to determine the appropriate adjusttent
factor. Enter the percentage increase on the worksheet.
(6) Review information relating to culpability of the violator.
If an adjusbient is in order, consult the guidelines to determine the
adjusbtent factor. Enter the adjustTent factor (20% or 40%) on the
worksheet,
-------
G—2
(7) Review sales data and culpability level to determine if an
adjus tent to account for Ability to Pay is appropriate (Ability to Pay
adjust nts are only made when there is a level 2 or 3 culpability).
Consult the guidelines to determine the adjustt nt factor ard enter
the percentage decrease on the worksheet.
(8) Total the percentages entered under Items (5), (6) and (7)
and adjust the GB? in Item (4) by this percentage. Enter the resulting
npdi fied GB? on the worksheet.
(9) Enter the explanation for n dification of the base figure
for each primary charge on the reverse of the Worksheet.
(10) Enter the “proposed civil penalty” for each primary charge
listed under Item (2). Where there has been no nodifi tion, the
pr osed penalty will be the sama as the base figure under Item (4).
For any primary charge for which the base figure has been increased
or decreased, the “rrodified penalty base figure” derived under Item
(8) shall be entered as the proposed penalty.
(11) Enter as the “total proposed penalty” the sum of the “pro
posed penalties” entered under Itent (10).
(12) If at the settlemant conference, respondent makes and sub-
stantiates additional representations concerning history of violation,
culpability, inability to pay or remain in bssiness or “such other
matters as justice may reguire” which the Agency could consider in
mitigating the proposed penalty, enter a sumary of the new facts
and their substantiation. In the absence of facts and circumstances
which present a legitimate basis for reduction, the Agency is under
no canpulsion to mitigate the proposed penalty.
(13) If reduction is deen d appropriate for the cenalty proposed
for a given charge, enter the percentage by which the proposed penalty
should be further decreased.
(14) Canpute the “negotiated penalty ancunt° for each primary
charge based on the percentage reduction (indicated in Item (13)) of
the penalty prcx osed for that charge (indicated in Item (10)), and
enter the anount.
(15) Enter the “final civil penatly ancunt” for each primary
charge. Where there has been no negotiation or reduction, the final
penalty will be the sama as the proposed penalty for that charge under
Item (10). Where there has been a reduction from the proposed penalty,
the “negotiated penalty anount” under Item (14) shall be the final
penalty ancunt.
-------
G—3
(16) If the respondent in oduces new facts at the settle nt con-
ference which bear on the gravity of the violation ard which u ay rrodify
the original d arges, enter the date of the conference, a auttnary of the
new facts, ard a suJnriary of the substantiation. Then begin a new Work-
sheet to reflect the irodified tharges ard a new proposed rena] ty.
Total Final Civil Penalty Assessed
(17) Enter the “total final civil ena1ty assessed” as a result of
the fo11 iirg: (a) Default (nuTrber 4 in the heailrg of the Worksheet);
(b) consent aqreenent (nun er 5 in the headir of the Worksheet) after
a settle tent conference;
(18) Enter the “total final civil penalty imposed” as a result of
the Final Order of the Regional Administrator.
-------
icenflr Si
clvii . PUIMTI MS 5&lDfr Iiwcsnt r
!&iir 01
kUrrsi ol iLsp nh1ent
1. Carplalnt 1.D. to._________
3. I aLa caiiplalnt lus’ I______
3. tote Ans .ie I c’d_________
4. toto tolauLi (xdsr Sent_
5. tote Coiucnt D Jrecri ,it.
bl ne I___________________
5. l )t.e WI,ial I .Iuc Sent
3. tote mttt ..n h.cd
I i i
O.ac Je
ti,M
sv . r
avity tore I’enaity
(2) 4I
KIi ary alP
tharqe(r) I Iavxi t in
matria i*Ll)
.
(I)
Iiletoq
Perrenta e
increar.
&ijuetiuonte
I’)
Qilpablilty
Percentage
tocrearu
Ill
Inability to
Pay Percentage
tocteare
j nsLd Ie,k.L%v
TuF
ltiSItl.J (JIl•
(S reflect i,,j
lccea e, oc
d. crea o it
aiiiil tel )
flI)
Ircjxueil
Penalty
Jiltueted Penalty
( 3)
Peccenta a (I(
nacreaee
(toLat Lo bl.tmy.
ailpability.
Inability to pay,
other setters as
justice say
require
Final
( ii) (I
t iegotlatoi Fir
Penalty a L Ch
45 re il.ctliq S Per
decrease it
applied)
•
(I I
tos ec lnclukd Oiat (a)
11)
tal
Final CIv$I Penalty Ass.s..d$
Kep rsL by____________________________
U)
taI
lr o.ed Penalty $__________________________
IS)
1i)tM
Final Civil Penalty iir rtoi L
Owoarrence by____________________________
-,—- . •I—
- .— —
—-—- —-. -,‘. — —
-------
(9) Mo i 1Cat Cn the Penalty aase P qure (ur J r Line(s)
Date a M ifi ti fl
f or !‘ difi ti ____________________________________________________________________
Pd1ust r the P o eed C vU Penalty
.
Date of C feren ___________________________
(12) ?dditI a1
Mistecy
.
Su tantiatiOn
lp a t1ity
!
Subst.antiatio
Inability te Pay/ Coi%tirue If Thjiinass
FinancIal Data Of fer by Pasç nt (S irce Nd Sueslmry)
.
Other matters as justice may r airs
!
Subtantiaticn
.
(16) Day Gravity Date ninat
( Is v Facrs
I
Su tantiation
Prenar by
-------
APPENDE I
FE RAL R YflSTER PULICATI S
Marth 9, 1977 Original Prcposal of Inventory Reporting
Regulations (42 FR 12120)
April 12, 1977 Supplemental notice of prcposed ru1tht aking,
including ditiona1 information pertaining
to pr osed regulations , and instructions
for use of the Candidate List of Chemical
Substances (42 FR 19298)
April 28, 1977 Notice of availability of the Candidate List
of Chemical Substances for use in reporting
Chemicals for inclusion in the inventory.
(42 FR 21639)
July 8, 1977 Notice to amend procedures for securing a
ccpy of the Candidate List on cat puter-readab1e
tape (42 FR 35183)
August 2, 1977 Re-proposal of Inventory Reporting
Regulations (42 FR 39182)
October 3, 1977 Supplemental notice (42 FR 53804)
Dece!rber 23, 1977 Final Inventory Reporting Regulations
(42 FR 64572)
March 6, 1978 Supplemental Clarification and Notice of
Meetings (43 FR 9254)
April 17, 1978 Supplemental Clarification and Availability
(43 FR 16178)
October 24, 1978 Policy for Revised Inventory Reporting
and Draft Report Form (43 FR 49688)
-------
APPENDD( J—1
Statutory Authority for the Inventory Reportir Regulations and
Enforceu nt Pr ram
—Section 8(a)(l)(A) authorizes the Administrator to reguire, by rule, the
maintenance of records and subnission of reports regarding production by-
products, pcpulation exposure, etc of a chemical substance.
—Section 8(b) directs the Administrator to “.. .canpile, keep current,
and publish a list of each chemical substance .kiith is man.ifactured or
processed in the United States... Such list may not include any chemical
substance which was not menifactured or processed in the United States
within three years before the effective date of the rules pranulgated
pursuant to (the inventoryt
.The Administrator shall not include in such list any chemical sub-
stance which is manifactured or processed only in small quantities (as
defined by the Administrator by rule) solely for purposes of scientific
ex erinentation or analysis or chemical research on, or analysis of, such
substance or another substance, includirq such research or analysis for
the devel ment of a product.”
—Section 11(a) authorizes any duly designated representative of the
Administrator to “...insçect any establishment, facility or other premises
in which chemical substances or mixtures are marufactured, processed,
stored, or held before or after their distribution in c iui rce.. .Such
an insrect ion may only be made upon the presentation of aopr riate cre-
dentials and of a written notice to the ner, operator, or agent in tha e
of the premises.. .to be inspected. A separate notice shall be given for
each such inspection, but a notice shall not be r uired for each entry
u ade durir the period covered by the inspection. Each such inspection
shall be caimenced and canpieted with reasonable pranptness and shall be
conducted at reasonable times, within reasonable limits, and in a reason-
able manner.
—Section 11(b) authorizes inspections extending “...to all things with-
in the premises or conveyance inspected (including records, files, papers,
processes, controls, and facilities) bearing on whether the r uire!ents
of this Act applicable to the chemical substances or mixtures within such
premises or conveyance have been canplied with.
—Inspections are prchibited, under Section ll(b)(2), which extend to:
“(PL) financial data, (B) sales data (other than shipment data), (C) pricing
data, CD) personnel data, or (E) research data (other than data reguired
by this Act or under a rule pranulgated thereinder), unless the nature
and extent of such data are described with reasonable specificity in the
written notice r uired by (Section 11(a)].
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PIPPENDD 3—2
—Section 11(c) authorizes the Administrator tO require by subpoena
“...the attendance and testinony of witnesses and the production of
reports, papers, doo.inents, answers to questions, and other information
that the Administrator deems necessary” for carzyi ait this Act.
—Section 15(1) makes it “...unlawful for any person to fail or refuse
to cauply with.. .any requi en nt under Section 5 . . .or any rule praTlul—
gated or order issued under Section 5.”
—Section 15(2) makes it “...unlawful for any person to use for cami r-
cial purpcees a chemical substance or mixture .t ith such person knew
or ha3 reason to kno i was marnifactured, processed, or distributed in
caiu rce in violation of Section 5... a rule or order under Section 5...
or an order issued in action bra.ight under Sect ion 5....”
—Section 15(3) makes it “...unlawful for any person to fail or refuse
to (A) establish and maintain records, (B) su nit reports, notices, or
other information, or (C) permit access to or ccpyirig of records, as
required by this Act or a rule therainder.”
—Section 15(4) makes it “.. • unlawful for any person to fail or refuse
to permit entry or inspection as required by Section 11.”
—Section 16(a)(l) provides for the assessnent of civil na1ties not
to exceed $25,000 for each violation of Section 15.
—Section 16(b) provides for criminal penalties of fines of not nore than
$25,000 for each day of violation, or iinprisormerit for not more than one
year, or both, for knowing or willful violations of Section 15.
—Section 17(a) gives jurisdiction to the district cairts of the United
States to provide s cific enforcenent regarding the provisions of
section 15, or to caupell the taking of any action required by or under
this Act.
—Section 17(b) provides for seizure and condemnation of any substance,
mixture, or article marufactured, processed, or distributed in calmarce
in violation of this Act or any rule pranulgated or order issued under
this Act.
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. ‘—
.iif
I.
MEMORANDUM
SUBJECT:
TO:
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
JUN23 1980.
OFFICE OF ENFORCEMENT
1 ’ ’
Inventory Penalty Policy
Enforcement Division Directors
Air & Hazardous Materials Division Directors
Surveillance & Analysis Division Directors
Pesticide Branch Chiefs
Attached is the specific penalty policy which applies
the principles of the TSCA Penalty Policy to the Inventory
reporting requirements. This policy should be used by regional
personnel in recommending appropriate enforcement actions
for Inventory reporting violations.
D. Wilson
Deputy Assistant Administrator
for General Enforcement
Attachment
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Inventory Penalty Policy
Introduction
This section of the TSCA Penalty Policy describes the application
of the policy to violations of the Inventory reporting regulations,
a.
It addresses specifically:
1) The determination that a violation exists.
2) The circumstances under which assessment of a civil penalty
is appropriate.
3) The independently assessable charge.
4) The concept of multi—day violatidns.
5) Application of—the Gravity Based Penalty.
—6) The use of adjustment factors.
7) Relationship to 5 penalties.
II. Violation Deternunation
Each failure by a person to comply with a specific Inventory
reporting requirement for a single chemical substance shall constitute
separate violation. Inventory violations are listed in Appendix A,
‘Citation Charges and Action Levels for Violations of the Inventory
Reporting Regulations .
III. Appropriate Enforcement Action
• For violations of the Inventory reporting regulations EPA will,
in most cases, issue a notice of non—compliance or assess a civil
penalty. Criminal sanctions will generally be inappropriate for
Inventory reporting violations. They should be considered only for
extremely egregious violations which reflect a conscious attempt at
undermining of the Inventory reporting regulations.
-------
—.2 —
A notice of non—compliance will be the most appropriate action
if the following circumstances cist:
1) It cannot be held that the alleged violator “knew or shoul
have known” about the Inventory reporting regulations.
Circumst’ahces to be considered in determining the reasonable-
ness of a violation using this standard include: firm size,
subscription to the Federal Register and trade publications,
membership in trade associations, inclusion on Office of
Industry Assistance mailing lists and prior correspondence
with EPA regarding the Inventory requirements, or
2) The alleged-violator acted in “good faith” in attempting
to comply with the regulations. Generally, “good faith”
should be found if a firm made reasonable efforts’ to familiar-
ize itself with the Inventory reporting requirements, made a
systematic effort to identify its eligible substances, and
reported concerning them immediately upon identi ication, and
3) The violation could not have been expected to have a major
impact on the Agency’s ability to implement or enforce the
premanufacture notification requirement, or
4) The violation could not have been expected to have a major
impact on the accuracy of the chemical profile established
under the Inventory reporting requirements.
A notice of non—compliance would, for example, be appropriate
in the following circumstances:
1) A firm reported most of its substances by the reporting deadli
but reported a few “overlooked” substances after the deadline.
(One way of determining “good faith”. is by comparing the
number of late substances with an OTS printout of all substanC
-------
—3-
reported on time.J
2) A firm learnedof the reporting requirements late. Although
it began compliance efforts immediately, it was not able to
submit its substances on time.
[ Note: The “good faith” criterion does not apply to firms who
should reasonably have been aware of the Inventory reporting
requirement. I
A civil penalty will be the most appropriate action in cases where
circumstances indicate that a firm “knew or should have known” of the
procedural or substantive requirements of the r ulations or has not
made a “good faith” effort to comply. Whether a firm “knew or should
have known” is determined by balancing the complexity of the requirement
and the firm’s sophistication, size, resources, etc.
For example, a firm which subscribes to the Federal Register or
belongs to a trade association and yet fails to report a substantial.
number of its substances on time should be assessed a civil penalty for
late reporting. A civil penalty would be appropriate in this case
because the firm could reasonably be expected.to have familiarized
itself with TSCA requirements which are printed in the Federal Register
and made available through appropriate trade ass ciations,
In some cases, a person may be charged with several violations,
some of which merit a civil penalty while others merit only a notice of
non—compliance. In such cases, no separate notice of non—compliance
need be issued. Violations meriting a notice should be listed in
the complaint as separate counts without penalties.
-------
—4-
iv. Independently Assessable Charge
If a civil penalty is the appropriate type of enfcrcement
action for identified violations, the enforcement attorney/case
preparation off icer.rnust still determine whether a civil penalty
should be assessed for each identified violation. A separate
civil penalty shall be assessed only for each violation of the
Inventory reporting regulations which results from an independent
act (or failure to act) of the respondent and which is substantially
distinguishable from any other charge in the complaint. A given
charge is independent and substantially distinguishable from any
charge for the purpose of assessing separate penalties if each charge
requires an element of proof not required by the other. Thus, not
every charge, which may appear in the complaint will be separately
assessed. For example, a manufacturer may fail to report at all
concerning a chemical substance for which reporting is required.
He could be charged separately for failing to report each item of
information required by the regulations. However, since the charge
for failure to report at all contains the same elements required to
prove a failure to report individual items of information, a civil
penalty should be aisessed only for the failure to report at all.
V. Multi—day Violations
TSCA S16 authorizes the assessment of civil penalties not only
for each violation but for each day the violation continues. Since
the Inventory reporting regulations establish specific deadlines for
compliance, the duration of any violation discovered could be computei
from the appropriate deadline for compliance. Such an approach, howe
would result in excessive penalties. Therefore, for purposes of
-------
computing the civil penalty for an Inventory reporting violation, there
. j11 be only one day of violation, the day on which the violation is
iscovered by EPA. No Inventory violatidn will be considered a
continuing violation.
VI. Calculation of the Gravity Based Penalty
The Inventory’freporting regulations are classified as “hazard
assessment” data gathering regulations under the TSCA Penalty Policy.
The appropriate Gravity Based Penalty (GBP) for violations of these
regulations is determined by the extent of potential damage caused by
each violation as well as the circumstances surrounding the violation.
[ Note: The “damage” which determines the appropriate GBP for “hazard
—
assessment” violations--is different from the “damage” which determines
the GBP for “chemical control” and “control associated data gathering”
violations. The damage in the former case is to the abilityof the
agency to carry out its regulatory functions, while in the latter two
cases, the damage is to health or the envirornent. As a result, the
GBP for “hazard assessment” violations is based on consideration of
qualitative factors rather than of quantitative factors such as unds
of the chemical involved as is the case with the GB? for “chemical
control” and “control—associated data gatherir ” violations.]
The GB? matrix for the Inventory reporting regulations has been
modified to eliminate penalties in Level B (significant) on the “extent”
axis as well as penalties in a number of levels on the “circumstances”
axis. These modifications have been made because Inventory violations
are expected to be either quite serious or relatively insignificart.
There are no violations which would merit assessment of penalties at the
omitted levels. Therefore, only the penalties listed on the modified
matrix should be applied to Inventory violations. The modified GB?
matrix follows.
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-6—
Level C (Minor)—
cT r cF POT L M1 E
I
I
I OR
Level A
U NCES I D R
IFIC?NT
Level B
I
I
I I
I HIG
I
RANT I 1
12
25,000 I
f tENORI
Level C I
3 I
].5,000 I I
41
I I 1.0001
I L I 5 I
161
5,000 I 500
I I 200
A. Extent
The “extent” of damage caused by an Inventory reporting violation
is measnred—by I otential impact of the violation on the Ace cy’s
ability to implement and enforce TSCA. The GBP matrix for the
Inventory reporting regulations provides two levels for measuring
‘-‘tent:
“ ... rel A (Major) — Potential impairment of the Agency’s ability to
properly implement and enforce S5 P requirements
for a given substance.
Potential impairment of the Agency’s ability to
rely on the Inventor’s’ data base as a guide in
the hazard assessment process for chemicals in
commerce or for general enforcement of TSCA,
Potential impairment of the Agency’s ability to
complete timely processing of Inventory reporting
forms.
B. Circumstances 1
The vertical axis describes the “circumstances” affecting the
impact of the violation on the Agency’s ability to implement or
enforce TSCA.
The three ranges on the “circumstances” axis are described as follows:
High Range — The violation could result in the improper
Level 1 introduction of a chemical substance into
commerce without the required premanufacture
review, or
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— 7. —
Level 1 The violation causes the unnecessary submission of a
P? 1 by a third party, and the Agency has unnecessaril
spent the resources required for a complete premanu—
facture review.
Mid Range — The violation causes the i. necessary submission of a
Level 3 PMN by a third party, and the Agency has unnecessaril
spent resources in beginning premanufacture review.
Level 4 The violation results in impairment of the Agency’s
Inventory data base with respect to all items of
information required to be reported concerning a
chemical substance.
Low Range The violation has unnecessarily caused the Agency to
Level 5 receive premanufacture notification forms for a given
chemical.
Level 5 The violation could have resulted in subversion of
the. PMN requirement if the substance had been
included on the Inventory.
Level 5 The violation results in impairment of the Agency’s
Inventory data base with respect to less than the
total number of information items required to be
reported Concerning a chemical substance.
Level 6 The violation could have resulted in impairment of
the Agency’s Inventory data base with respect to
some information items required to be reported
concerning a chemical substance if the information
bad been included in the data base.
Level 6 The violation has caused the Agency to expend unantic-
ipated resources related to the processing of
Inventory forms.
C. Application of the GBP System to Inventory Reporting Violations
All Inventory reporting violations not associated with a- “good fait
effort to comply or committed by persons who knew or should have known”
about the Inventory reporting regulations can be assessed penalties
under this application of the penalty policy as follows:
o Reporting an Excluded Substance
Major
$25,000 High Violation impairs EPA’S ability to properly
Level 1 implement S5 in that it could result in
avoidance of timely premanufacture notificatior
because the substance was included on the
Inventory .
-------
$5,000 Major
Low The substance reported is ineligible for
Level 5 inclusion on the Inventory. Although thc
substance was not included on the Invent
the Agency had to expend substantial resL
to prevent subversion of the 55 PMN require-.
men t.
Citation Charge Codes A13—21 (See Appendix A)
o Reporting False Information
Minor
$500 Low Substantial inaccuracies in a single report
Level 5 form are expected to impair the EPA hazard
assessment and compliance monitoring
processes.
Minor
$200 Low Substantial inaccuracies in a single report
Level 6 form could have impaired the EPA hazard
assessment and compliance monitoring
processes had the information been
included in the data base. (later report).
[ Note: A violation will be found and will be
assessed for each inaccurately reported item.
Citation Charge Codes A8—].2
o Failure to Maintain Records
Major
$25,000 High The lack of production and commercial use
Level 1 records cannot be compensated by other
information to substantiate reporting
of a non—excluded substance.
Citation Charge Code A22
o Failure to Report
Major
$25,000 High The violation impairs EPA’s ability to proper
Level 1 implement S5 in that it may result in need-
less P 4 by a third party.
Minor
$1,000 Mid If the substance was reported by someone
Level 4 else, the violation affects the Agency t s
ability to use the Inventory data as a
basis for hazard assessment and compliance
monitoring.
Citation Charge Codes Al—6
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—9—
0 Failure to Report on Time
Major
$25,000 High Persons whose late reporting has resulted in
Level 1 the commencement of PMN activity will be
15,000 Mid assessed a penalty ‘nder the Major extent
Level 3 category. The penalty level assessed will
5,000 Lo t’ depend on the stage of the PMN review process
Level 5 at the time the late report is received.
persons whose late submissions have not inter-
fered directly with the PMN process but will
result in unanticipated expenditure of Agency
resources in updating the Inventory will be
assessed a Minor/Low penalty of $200/chemical.
Citation Charge Codes A7
VII. Adjustment Factors
The adjust nent factors discussed in the TSCA Penalty Policy pages
9—17 can be applied to Inventory violations without further modification.
II. Relationship to Penalties under S5 TSCA
It should be noted that certain Inventory reporting violations may
result in violation of the S5 premanufacture notification requirements
as well. For example, a person who fails to report for the Inventory as
required and does not submit a PMN may be assessed a one—time civil
penalty for the Inventory violation and a daily civil penalty for
manufacturing contrary to S5 requirements.
-------
Appendix A
Sample Citation Charges and Action Levels for Violations of the
Inventory Reporting Regulations Promulgated Under Section 8(a)
the Toxic Substances Control Act
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE INVENTORY REPORTING
REQqIREMENTS PROMULGATED UNDER SECTION 8(a) OF THE TOXIC SUBSTANCES
CONTROL ACT IN THAT TUE PERSON:
Al. Failed to report concerning a chemical substance manufactured in
the U.S. for a commercial purpose during 1977 as required because
30% or more by weight of the products manufactured are described
by Standard Industrial Classification (SIC) Group 28 or 2911.
(40 CFR S710.3(a)(l) (i) (A))
Action Level: Complaint and/or
Premanufacture Notification Requirement*
A2. Failed to reoort concerning a chemical substance manufactured in
the U.S. for a commercial purpose during 1977 as required because
the total pounds of reportable chemical substances manufactured at
that site equals one million pounds or more.
(40 CFR S710.3 a)(l) (i)(B)
Action Level: Complaint and/or
Premanufacture Notification Requirement
3. Failed to report concerning a chemical substance manufactured in
the U.S. for a commercial purpose during 1977 as required because
manufactured at a site in quantities equal to or greater than
100,000 pounds. (40 CFR S7l0.3(a) (l)(ii))
Action Level: Complaint and/or
Preznanufacture Notification Requirement*
A4. Failed to re rt concerning a chemical sub tance imported into the
U.S. for a commercial purpose because 30% or more of the products
imported are described by Standard Industrial Classification (SIC)
Group 28 or 2911. (40 CFR S71.0.3(a)(2) (l)(i)(A))
Action Level: Complaint and/or
Premanufacture Notification Requir nent*
A5. Failed to report concerning a chemical substance imported into the
U.S. for a commercial purpose during 1977 as required because the
total pounds of reportable chemical substances imported equals one
million pounds or more. (40 CFR S710.3(a) (2)(i)(B))
Action Level: Complaint and/or
Premanufacture Notification Requirement*
k complaint alone will be appropriate in cases where another person h
sported concerning the chemical substance. PMN should be required
j.n addition to issuing a complaint in cases where the substance
has not already been reported for the Inventory.
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A-2
A6. Failed to report Concerning a chemical substance imported into
the U.S. ’ for a commercial purpose during 1977 a.s required
because imported in quantities equal to or greater than
100,000 pounds. (40 CFR S710.3 (a)(2)(i)(B))
Action Level: Complaint and/or
Premanufacture Notification Requirexnent*
A7. Failed to report a chemical substance by the u1y 1, 1979 dead-
line. (40 CFR S710.6(b))
Action Level: Notice of Non—compliance or
Complaint and/or
Premanufacture Notification Requirement*
A8. Falsely reported the site at which he manufactured the chemical
substance as required for all but small manufacturers.
(40 CFR §710.5(d) (2))
Action Level: Notice of Non—compliance or
Complaint
A9. Falsely reported the business address at which he imported the
chemical substance as required for all but small importers.
(40 CFR S710.5(d) (2))
Action Level: Notice of Non—compliance or
Complaint
AlO. Falsely reported the amount of the chemical substance which
- he manufactured at each site for which reporting was
required in 1977. (40 CFR S710.5(d)(4))
Action Level: Notice of Non—compliance or
Complaint
All. Falsely reported the amount of the chemical substance which he
imported during 1977. (40 CFR §710.5(d) (4))•
Action Level: Notice of Non—compliance or
Complaint
A12. Falsely reported that manufacture of the chemical substance is
site limited. (40 CFR S710.5(d) (3))
Action Level: Notice of Non—compliance or
Complaint
* See Appendix A—i
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A13. Reported a chemical substance excluded from the Inventory
because regulated under the Federal Insecticide, Fungicide
and Rodenticide Act. (40 CFR S710.4(c)(l))
Action Level: Notice of Non—compliance
Complaint and/or
preinanufacture Notification Requirement**
A14. Reported a cb mica1 substance excluded from the inventory
because regulated under the Federal Food, Drug and
Cosmetic Act. (40 CFR S710.4(c)(l))
Action Level: Notice of Non—compliance
Complaint and/or
preinanufacture Notification Requirement**
A15. Reported a chemical substance excluded from the inventory
because manufactured solely in small quantities for
research and development. (40 CFR S710.4(c)(3))
Action Level: Notice of Non—compliance or
Complaint and/or
Premanufacture Notification RequireTnent**
A16. Reported a chemical substance excluded from the inventory
because imported solely in small quantities for the
research and development. (40 CFR 5710.4(c) (3))
Action Level: Notice of Non—compliance or
;Coinplaint and/or
Premanufacture Notification Requirement**
A17.. Reported a chemical substance excluded from the inventory
because processed solely in small quantities for research
and development. (40 CFR S710.4(c)3))
Action Level: Notice of Non—compliance or
Complaint
A18. Reported a chemical substance excluded from the inventory
because not manufactured processed or imported for a
commercial purpose after January 1, 1975. (40 CFR
5710.4(c) (4))
Action Level: Notice of Non—compliance or
Complaint and/or
Premanufacture Notification Requirelnent**
A complaint alone will be appropriate in cases where the excluded
substance has not been introduced into commerce since its improper
reporting. A PMN should be required in addition to a civil
penalty in cases where the excluded substance has been in-
troduced into commerce since its improper reporting.
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A19 1 Reported a chemical substance excluded from the Inventory
because it is an impurity. (40 CFR S7.l0.4(d) (1))
ion Level: Notice of Non—compliance or
Complaint and/cr
Premanufacture Notification Requirement**
A20. Reported a chem’i al substance excluded from the Inventory
because it is a byproduct with no commercial purpose. (40 CFR
5710.4(d) (2))
Action Level: Notice of Non—compliance or
Complaint and/or
Premanufacture Notification Requirement**
A21. Reported a chemical substance excluded from the Inventory
because it is a non—isolated intermediate. (40 CFR §710.4(d) (8))
Action Level: Notice of Non—compliance or
Complaint and/or
Premanufacture Notification Requirement**
A22. Failed to maintain records that document information reported
under the regulations. (40 CFR §710.1 (c))
tion Level: Notice of Non—compliance or
Complaint
**See A—3
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. .,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C 20460
July 22, 1982
orruct or
.11 YSCIOCS AND TOXIC $USStANCE$
MEMORANDUM
SUBJECT: Compliance Strategy for the Prehminary Assessment
Information Reporting Rule (Level A kulej
TO: Air and Hazardous Materials Division Directors
Environmental Services Division Directors
Toxic Substances Branch Chiefs
The final version of the Level A Rule was published in
tne Federal Register on June 22, 1982 (47 Federal Register
2599 ). Attacnea is the Compliance Strategy for tn s
rule. A prd posed strategy was circulated in July, 1980, for
coent. This document reflects coninents on the proposed
strategy and changes to. the proposed rule.
i you have any questions please contact Pa.r.ela Harris
(FTS 755—940 .) of my staff.
A. E. Conroy 11, i ector
Pesticides and To I Substances
£ntjrcement Dlvi on
Attachment
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COMPLIANCE STRATEGY
FOR
PRELIMINARY ASSESSMENT INFORMATION REPORTING RULE
(LEVEL A)
Pesticides and Toxic Substances Enforcement Division
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COMPLIANCE STRATEGY FOR THE PRELIMINARY ASSESSMENTS
IUFORMATION REPORTING RULE (Level A Rule)
Overview . . . . . . . . . . . . . . . . . . . . . . . . 1
Requirements of the Regulation . . . . . . 1
Who Must Report
Listed Chemicals
Exemptions
What to Report
Reporting Period
When to Report
Where to Report
Compliance Assistance . . . . . . . . • • • • • • •
Regulated Industries . . . . . . . . . . . . . . . . . 5
Compliance Background . . . . . . . . . . . . . . . . ..6
Obj ectives
Types of Violation
Compliance Monitoring . . . . . . . . . . . . . . . . . 7
phase I: Reports Processing
Phase 11: Neutral Administrative Inspections Scheme
Phase III: Response to Tips and Complaints
Inspection Scheme
Administrative Considerations . . . . . . . .10
Program Management
Allocation of Responsibility
Program Integration
APPENDiX: Definitions of Terms
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• ii • tra t v t ’c ‘re i ni ‘ ry s ses slien t Ii torr ti ti Report i
Rule : nder CA ¶ S(a) - (Level A Reporting u1e)
(ve V iew —
The Environmental Protection Agency (EPA) published the Preliminary
Assessment Information Reporting Rule on June 22, 1982, under the
authority of Section 8’ l of the Toxic substances Control Act
(47 Federal Register Manufacturers Including importers must
submit a report for each listed chemical manufacturered at each site.
The information collected under this rule will Include current Infor-
mation on production, uses and potential exposures for about 250
chemicals listed in the final rule. These chemicals come from the ITC
lists and the list of chemicals for which Information was submitted
under section 8(e). A proposed amendment adds about 50 chemicals to
the list and makes reporting automatic for chemicals listed by the
Interagency Testing Committee (ITC) as possibly hazardous chemicals,
The Agency will use the data gathered under this rule to decide whether
to initiate rulemaking on these chemicals, to set priorities for
testing chemicals and to assess risks associated with chemicals.
Possible future rules under TSCA regulating these chemicals include §6
Regulatory Rules, §4 Test Rules or S8 Reporting Rules.
The Preliminary Assessment Information Reporting Rule anticipates tw3
rounds of reporting. The first round applies to manufacturers of the
chemicals listed in §712.30 of the rule. Processors will report in
the second round of reporting, the procedures for which have been
reproposed in 47 Fed. Reg . 27009, dated June 22,1982. Processors
il1 be asked to report only if the Agency does not obtain sufficient
1nfor ation about the chemicals from the ianufacturers.
The Pesticides and Toxic Substances Enforcement Division (PTSED) wil’
concentrate its major compliance monitoring efforts on the detection
of the following violations: (1) failure to report, (2) incomplete
or inconsistent reports, and (3) the reporting of false information.
These violations undermine the risk assessment process and potentially
prevent regulation of a dangerous chemical. The enforcement activities
will also assist OTS in assessing overall validity of the Information
submi tted.
Requirements of the Regulation
Who Must Report
Manufacturers who have to report are those who produce or import any
of the listed chemical substances or who apply any method of extractions
refinement or purification to a mined substance to make ft marketable
as alisted chemical substance. (An undefined or variable concentra-
tion mixture not intended for marketing as a listed chemical is not
subject to this rule.)
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!mporters should report chemical substances imported in bulk in any
grade of purity, In aqueous solution or containing additives (such
as stabilizers or other chemicals) to maintain the Integrity or
physical form of the substance. This does not lnclude..formulated
mixtures of two or more chemicals that are not additives.
Listed Chemicals
The final rule applies to the approximately 250 chemical substances
and three categories listed by Chemical Abstract Service (CAS) number
in 40 CFR S712.30. (The three categories of chemicals need to be
considered only by persons who reported confidential chemical
identities for the Inventory.)
Those subject to this rule should report an Isomer under the specific
Isomer CAS number if they were producing an isomer alone. They
should report a chemical under the more general CAS number if they
are producing a mixture of isomers. This Is the same policy used
for inventory reporting.
Exemptions
A small business exemption applies If a site satisfies both of the
following two criteria:
o It manufactures less than 45,400 kilograms (100,000 pounds)
of the chemical and
o The parent company sales are less than S30,000,000.
A small cuantity exemption applies If a site manufactures less than
500 kilograms (1,100 pounds) of the chemical.
Other exemptions are for Importers of mixtures and articles, manufac-
turers of research and developme t chemicals (1) and manufacturers
who solely produce the chemical as an Impurity or a byproduct or a
nonisolated intermediate. There are no exemptions for test marketing
(2). —
(1) Research ‘and development chemicals: This term Includes use of
the chemical for scientific experimentation, analysis (for example,
use as reagents or Indicators for quality control), and research,
including research or analysis for product development. This exemp-
tion applies only If there are no commercial uses of the chemical.
If there are commercial uses, then both the commercial and the
research and development uses must be reported.
(2) Test marketing: This term means distribution In commerce of a
limited amount of a chemical substance or mixture or article con—
taming such substance or mixture to a defined number of potential
customers during a predetermined testing period to explore market
capability prior to broader distribution in commerce.
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What to Report
The information required by this rule must be reported on the
Preliminary Assessment Information Reporting forn. (A copy of
the form begins on page 27005 of the attached Federal Register
Notice.)
Persons subject to this rule must submit an individual form for
each site manufacturing or Importing a chemical substance listed
in the rule.
The submitter reports information about the reporting year, the
name and CAS number of the chemical, the reporting establishment,
its location and technical contact on page one of the form. On
page two the submitter answers questions about production, processing,
use and exposure of the chemical. The Agency will use this information
as part of Its regulatory priority setting process.
Submitters should report ureadily ascertainable” Information. This
is the most accurate Information easily available to the submitter.
The data reporting section of the form (Section IV on page 2) has
two parts: Part A: Plant Site Activities and Part B: Chemlca
Substance Processing. Production, processing and use at each single
domestic manufacturing site must be reported on Part A. Part A
information also includes the number of workers, and quantities of
the chemical that are or are not recovered. Part B of the form applies
to the processing of the chemical by others. Part B will account for
the quantity of chemical that Is distributed from the manufacturing
site. The answers to the questions on this part of the form will
allow the Agency to determine the extent of exposure to workers, the
environment and the aeneral population from the chemical.
rart A
° items 1 and 2 — Total quantities of chemical imported
and domestically produced.
o Item 3 — Quantities of chemical lost
• Item 3(a) Indicates quant1ties of chemical lost during
manufacture. (3(a)— 3(b) + 3(c) + 3(d)).
— Item 3(b) Indicates quantities lost to the environment
— Item 3(c) indicates quantities in wastes treated to destroy
the chemical
- Item 3(d) indIcates quantities In wastes not treated to
destroy the chemical
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-,
Items 4. , 6, and 7 - Quantities of chemical, worker
hours an ni.rnber of wor €rs associated with enclosed,
controlled release and open process categories.
— Item 4 covers manufacture of the chemical.
• Item 5 covers on site use as a reactant.
- Item 6 covers on site nonreactant.
- Item 7 covers on site preparation of products.
Item B — Quantity of chemical the manufacturer makes Into
products to be used by industry or In consumer products,
includes:
— The chemical itself and mixtures containing the chemical.
- Articles with some release of the chemical possible.
- Articles with no release.
Part B
Item 9 - Quantity of chemical the customer makes into
products to be used by industry or consumers.
0 Item 10 - Trade names under which the manufacturer markets
the chemical to his customers. (To be answered only if
customers’ uses are unknown for more than 20 percent of
the total quantity manufacttzred and imported.)
0 Item 11 — Manufacturer’s estimate of the quantity of chemical
that is processed in enclosed, controlled or open processes
by their customers.
Reporting Period
A company should report a chemical’s production during the last
complete corporate fiscal year as of the date the chemical is listed
In 712.3O. (The company reports the period covered by Its report
on page 1 In the upper right corner.) If the ompany d d not
manufacture a chemical during that year 1 it does not report or that
chemical
When to Report
Companies should report to EPA within four months of the effective
date of the rule, July 22, 1982. Companies may obtain extensions or
deadlines for resubmisslon from OTS for good cause. (The Assessment
Division wlfl provide procedures for granting extensions). -
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‘ here to Report
Reports should be returned to EPA at the following address:
Document Control Officer
Office of Pesticides and 13 j Substances
Environmental Protection Agency
p. 0. Box 2080
Rockville, Maryland 20852
Compliance Ass I stance
Information about the rule has been published in various trade
journals, such as those published by the Chemical Manufacturers
Association, Chemical and Engineering News and others, so that
the chemical industries subject to the rule wifl be well informed
about its content. The Industry Assistance Office (LAO) will send
copies of the Federal Register notice and the form to all known
manufacturers of the substances (from Information submitted for
the inventory). Members of CMA will not receive packages in the
initial mailing. Under an agreement between CMA and LAO, CMA
members will call LAO and specify the number of forms needed and
the contact to whot LAO should mail the forms. LAO will then mail
the forms to these people. (This procedure has been adopted because
the mailing list is set up to mail forms to plant sites whereas most
MA members will want the forms mailed to corporate headquarters.) LAO
will keep a list of all companies to which it mailed forms. Persons
who do not receive forms as a result of the initial mailings may
obtain them by calling the lAO (800-454—9065) which Is the source of
all forms. Persons who need assistance In filling Out the forms, may
also call LAO which will direct their question to someone in the Agency
who can assist them. This person will return the call. In addition,
persons who submit forms that reflect misunderstandings of the
instruction will receive a chance to correct them. OTS will return the
original, incorrect form to the submitter with a letter explaining the
form’s deficencles and a deadline for resubmission. Submitters who
desire further advice on resubmlssions may call LAO.
Regulated Industries
Manufacturers of the 250 chemicals named will be required to report
the Information requested on the appropriate forms. - It is anticipated
that 330 companIes will report on activities at 450 plants for a total
of 1300 reports. Processors may be asked to report at a later date.
LAO will supply PTSED with a list of companies which may be subject to
the rule based on the Inventory and the updated IOA mailing list of the
reporting forms.
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CoióllTnce ckg’ound - — - ________ _____________________
Objectives
The objective of the compi lance strategy Is to ensure that all
required information is reported In a ti iely and accurate fashion.
Types of Violation
There are four types of violations under TSCA S15C3’i(B):
o FalsIfication of reports;
o Failure to report;
o Incomplete or Inconsistent reporting;
o Late reports.
Falsification of Reports : Falsification of any of the items required
by the rule would lead the EPA to draw Incorrect conclusions about
the threat to health and the environment posed by the continued
manufacture or import of the chemical.
Submission of a falslfieø form does not satisfy the requirenents of
this rule under TSCA S8(a), and Is a violation of TSCA Sl5(3)(Sl of
TSCA. In addition, knowing falsification of Information submitted
to the government is a criminal offense.
Failure to Report : Failure to submit a completed report as required
by the rule would greatly impair the Agency’s ability to make
decisions concerning a chemical’s effects on health and environ-
ment. Failure to subn it the reports required by this rule Is a
violation of TSCA S15(3)(B).
Failure to Report Comoletely or Consistently : Incomplete or
inconsistent reports also impair the Agency s ability to make
informed regulatory decisions. Incomplete or Inaccurate forms
do not satisfy the requirements of this rule. In many cases, OTS
will give the submitter a chance to correct an incomplete or
Inconsistent form. Reports submitted within the time granted by 015
for resubmission of corrected or completed forms will not be treated
as violations. Continued resubmission (after two correction cycles)
of Incomplete or inconsistent forms will be treated as a violation.
Failure to Report on Time : Late reports Impair the Agency’s ability
to compile data on individual chemicals. The data requested Is
necessary to determine if further action is necessary under ISCA
and If so, what form It should take. Late reports unnecessarily
delay the regulatory process. Reports which arrive later than 30
days after the deadl me for submi ttal , resubmi ttal or extension will
be referred to PTSED for enforcement response. COTS will process
reports which are less than 30 days late in the normal manner.)
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t 1 c ciorinj
:3mpHaflCe monitoring for this rule wlfl be performed in three
phases. These phases are keports Processing and Verification,
Neutral Administrative Inspections, and kesponse to Tipsand Com-
plaints. At all times, during all three phases afl Information
reported or ccjUectea fr m companies will be treated as Confidential
Business Information (C61 following TSCA CR! procedures unless
otherwise specifically cleared through proper channels. Each phase
depends to some extent upon cooperation between PTSED and OTS. Since
OTS is familiar with the regulated community, it will play a significant
role in violation detection.
Phase 1: Reports Processing and Verification
Phase I of the compliance monitoring scheme is intended to detect
incomplete or Inconsistent reports and late reports. These viola-
tions will be detected In the course of routine processing of reports
by the Informatics General Corporation, the contractor for OTS.
Review of forms will Indicate incomplete reports. Reports which
contain certain types of inconsistent information wifl also be
detected as part of the routine processing. Late reports are those
received significantly later (30 days) than the required deadline.
Many inconsistent and incomplete forms will be the result of
misunderstanding of the reporting requ1re nents and procedures.
OTS will return an incomplete or Inconsistent form to the site
which subr itted It for correction. (See uCompliance Assistance”
or an explanation of the procedure for this activity.) If the
completed or corrected form is sent to OTS within the designated
time, no enforcement action will be necessary. If no satisfactory
response is forthcominc, OTS will refer Incomplete or Inconsistent
reporting, as well as late reporting and apparent nonreporting
violations to PTSED for appropriate enforcement response. Documen-
tation of OTS contacts with the company In violation will accompany
the referral. OTS will also certify, as appropriate, that the Agency
did not receive the reports within 30 days of the allowed reporting
deadline or that the reports do not satisfy the requirements of the
rule.
Since these violations are usually self—evident, and will generally
be confirmed In the course of OTS correspondence with the Company,
no inspections will be necessary for this phase of the program.
Violation detection activities by OTS In this phase are a conse-
quence of the routine processing of the forms by Informatics. Details
of the OTS processing procedures are available from the Information
Control Branch (ICR) of OTS.
Phase II: Neutral Administrative Inspection Scheme (NAIS )
Phase II will detect falsification of Information from sites which
filed completed forms and some failures to report. This will be
accomplished by performing verlficatlon’fnspections.
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Vt r fication iispections will be targeted froi’i among all the sites
WhiCh suDmlttei for’r . As the EPA receives the reporting forms,
e data along with the document control number for each form will
put into the Computer. The computer data base will then contain
,roduction and geographical information on all reporting sites. A
computer program will select the sites to be inspected using two
Cr1 teria:
o Size - one fourth of the sites selected for inspection
will be in the top fourth of those submitting forms by
production volume, one fourth will be in the second fourth
and so forth.
o Geographical distribution — the percent of sites chosen
in any state should equal the percent of the total forms
received which came from that State.
Within these two parameters selection will be random. The computer
program will consider an initial universe that consists of all sites
which reported.
A few, about 5-10%, of the verification Inspections will investigate
companies which did not report but are listed on the Inventory as
manufacturers of a listed chemical. These inspections will be targeted
by the Compliance Monitoring Branch CCMB) from Headquaters. The •CMB
will obtain from lAO a list of sites which received forms or are on the
inventory as manufacturers of Level A chemicals. Together with OTS,
M8 will determine which sites on the list did not return forms.
panies which are clearly no longer in business or have already been
entified as violators of the rule will be deleted from the list of
non-reporters. These inspections will be targeted so that the percent
of the inspections performed in each Region is equal to the percent of
companies on the list which are in that Region. Otherwise the, selection
will be random.
Inspection reports will be forwarded to PTSED’s Compliance Monitoring
Branch (Ct B). These reports will be compared with Information received
by OTS. OTS and PTSED personnel will decide If the information obtained
during the Inspection Is consistent with the information reported to the
Agency. If It Is not, then PTS D will refer the case to the Region for
appropriate action.
Significant, unexplained differences between data reported and the
data in the file represent a violation. The Agency will take enforce-
ment action.
Phase III: Response to Tips and Complaints
Some violations may be reported to EPA by complaints from competitors,
former employes or other sources. Referrals from the various divisions
of 01$ are another source of Information about possible violations.
These complaints will be forwarded to PISED for investigation. The
nature of the investigation will depend on the nature of •the alleged
olatlon. The first step of an investigation is to determine If
e manufacturer Is subject to the rule and If a report has been
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-9-
received by OTS. The case will then be referred back to the Regions
for an on site Inspection, If appropriate. The Agency will investigatP
all complaints and Initiate an enforcement response, If indicated.
Inspection Scheme
There are two reasons for an Inspection of a company.
1. Suspicion of violation based on a complaint or tip
or referral from OTS.
2. VerIfication of data submitted by companies. (Neutral
Administrative inspection Scheme — See Phase II ).
Both types of inspections will be targeted from Headquarters (CMB)
on a quarterly basis. The Agency will investigate all allegations
of violations. Allegations which are received In the regions should
be forwarded to headquarters. At least 50% of resources available
for Level A inspections will be used to perform NAIS Inspections.
CMB will begin targeting Inspections 90 days after the compliance
deadline. ThIs 90 days allows time for the processing of a large
number of reports so that the selection of sites will be more truly
random within the parameters. This time will also allow for the
resolution of some reporting problems.
Each quarter CMB will know how many inspections each Region will
have to perform to investigate allegations of violations.
CMB will target Inspections of companies which did not return forms.
This number will not exceed 10% of the inspections performed during
that quarter. (This number may be increased If the Agency discovers
that a large number of violations are occurring in this group.)
CMB will then ask the reports processing group to target the
remaining inspections using the selection program described In
the discussion of Phase II. At least S alternates should also
be selected (CMB may vary this number based on experience). If
a company selected by the program has already been Inspected
or targeted, CMB will replace It with one of the alternates.
This procedure will target manufacturing sites. CMB should call
the technical contact reported on the form and determine whether
the pertinent records are available at the plant site or at
corporate headquarters. The location of the records will be the
location of the inspection. By consulting the Inventory and the
computer where information from all the forms is stored, CMB can
develop a list of all Level A chemicals potentially manufactured
by the targeted site or company. CMB will select a maximum of
ten chemicals for the Inspector to investigate. If the records on
these chemicals agree with the data reported, no further Inspections
will be performed. If there are discrepancies between the records
and the forms, then the Inspector will return to the company and
investigate all the pertinent records on all the chemicals.
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hH the rule has no recordkeeping requirements, relevant records
ire likely to be kept for ta* or business purposes, or to comply
with other Federal regulations. Section 11 of TSCA provides that
EPA has access to these records.
All companies inspected for compliance with Level A will also be
inspected for compliance with all other appropriate TSCA rules
dnd regulations. Also companies subject to Level A reporting
requirements will be inspected for compliance with this rule If EPA
inspectors visit the company for any other TSCA inspection.
IJMIIST kTIYE CO IDERATIO JS
Program Management
P.TSED and OTS have developed report processing procedures that will
detect suspected violations of failure to report, failure to report
completely and consistently, and late reporting. PISED and OTS will
also target inspections under the NAIS described In this document.
The Regions will conduct the Inspections.
Coordination with OTS is important. The results of inspections will
incidentally give OTS an estimate of the overall reliability of the
data reported under this rule.
Assistance from OTS is necessary to violation detection. A key piece
of evidence to false reporting is the report that OTS received. Per.
sonnel from OTS will also help enforcement personnel determine the
significance of discrepancies between data reported and data found
in the files. Since the rule only requires that “readily available
information” be used to complete the form, there are plausible
explanations for some minor Inconsistencies between data already on
file with EPA and data discovered In the course of an Inspection.
Consult t1on with OTS will be necessary in most cases, so that only
significant inconsistencies are the subject of enforcement actions.
Any tips that indicate a possible violation will be Investigated first
at Headquarters. If further Investigation Is indicated, the case will
be referred to the Region. A result of all inspections will be sent
to the Compliance Monitoring Branch (CMB). CMB wlfl collaborate with
jOTS to determine If a violation has occurred. Any violations detected
by Headquarters or the Regions will be referred to the appropriate
Region for enforcement response, with concurrence from Headquarters.
Allocation of Responsibility
PTSED
o PolIcy and Stategy Guidance
o LIaison between Regions and 015
o VIolation determination (with 015)
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OTS
o Processing of reports (detection and cert1 cat1on of reporting
viol ations)
o Targeting AIS inspections using computer program
o Assisting PTSED in determining when a violation has occurred
Regions
o Perform inspections
o Relay inspection reports to PTSED for determination
of violation
o Develop cases and litigation with Headquarters concurrence.
Program Integration
Information received under this Rule may be useful to working
groups which are developing regulations under TSCA for specific
chemicals. Release of data to these groups will be in conformance
with TSCA procedures for handling Confidential Business Information.
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L tlt,Iti3flS of Turr is
Byproduct : Any cherncal substance or 1xture produced
withOut a separate commercial intent di.rlng the manufa.cture,
processing, use, or disposal of another chemical SubStance
or mixture.
Chenicals from natural sources : Chemical substances which
are extractea tro.i:, an ore, from oil, or from any otner
ndtural Source.
Impurity : A chemical substance unintentionally present with
anotner chemical suostance or mixture.
Intermediate : Any chemical substance that is consumed, in
wnole or in part, In chemical redctions used for the Intentional
manufacture of other chemical substances or mixtures, or
that is intentionally present for the purpose of altering
t e rates of such cnemical reactions.
Non-isolated intermediates : Any intermediate that is not inten-
tional ly removec from tne equipment in which it Is manufactured,
ncluding the reaction vessel in whIch it is manufactured, equip-
ment which is ancillary to the reaction vessel, and any equipment
through whicn the substance passes during a continuous flow process,
but not including tanks or otner vessels In wnich the substance
is stored after its manufacture.
Reactant : A substance which enters into and is altered by
a cnemical reaction.
Process categories:
Enclosed Process - The process is designed and operated so that
there is not intentional release of the chemical. In this
pro:ess category, only fugitive or inadvertent releases occur
special measures are taken to prevent worker exposure and
environmental contamination. “Special medsures” refer to pro-
cedures and equipment that are monitored and used to prevent
worker exposure, and scrubbers and other recovery equipment
employed to prevent environmental release. equipment with
emergency pressure relief tenting would be allowed in this
category; routine venting would not. With regdrd to handling
the manufactured chemical, persons who handle closed pac ages
cont ininy the material would be counted under “enclosed process.u
Persons who package or transfer the unpackaged chemical would be
counted In one of the follo iing categories.
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— —
Controfled Nelease Process - The process Is operated in a
:ontrofled manner to mini aize reledse of the cnemical Into
the workplace. Release should generally be within prescribed
limits. These limits may be dictatedby government regulations
or by company guidelines. U the chemical Is vented outside
the plant, the process is a Ncontrofled release’ process. 130
not count general space ventilation fans.
Open Process — The chemical is routinely in direct contact with
the atmosphere (workplece or outside tne plant) and no measures
are taken to prevent release. For example, reaction vessels
are open vats, the chemical is transported or stored In open
containers, or the cnemical is freely vented into the workplace
atmosphere.
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‘a.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D C. 20460
DEC 1 2 1983
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
TO: Air and Waste Management Division Directors
Environmental Services Division Directors
SUBJECT: Compliance Strategy TSCA Section 8(d)
Attached is the Compliance Strategy for the recently
promulgated Toxic Substances Control Act (TSCA) Section 8(d)
Health and Safety Data Reporting Rule for the submission of
lists and copies of health and safety studies undertaken by•
manufacturers and’processors on specifically listed chemicals.
This rule requires manufacturers, processors, those who
propose to do so, or those who have manufactured or processed
a listed substance in the past (within ten years of the date
it was listed) to submit copies and lists of health and
safety studies known to or undertaken by them.
Enforcement of this rule will be largely responsive rather
than affirmative and will normally be initiated by Headquarters,
with Regional assistance.
If you have any questions concerning this Strategy please
contact Pamela Harris of my staff at FTS—382—5567.
A. E. Conroy
Compliance Mon
Office of Pesticides a
i rector
ng Staff
xic Substances
Atta chment
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21 flV 1983
COMPLIANCE STRATEGY FOR
TSCA SECTION 8(d)
COMPLIANCE MONITORING STAFF
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE U.S. ENVIRONMENTAL PROTECTION AGENCY
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COMPLIANCE STRATEGY FOR
TSCA SECTION 8(d)
CONTENTS
Overview . . . . 1
Regulated Industry . . . . . . . . . . . 1
Requirements of the Rule 1
Enforcement Objectives . . . . . . . . . . . . . 5
Voluntary Compliance . . . . . . . . . . . . . . . . . . . . 6
Types of Violation . . . . . . . • • • • • • • • • , 6
Violation Detection . . . . . . . . . . . . . • • • • • • • • 6
Application of Detection Methods . . . . . .. . . . . . . . , 8
Priorities . . . . . . . . . . . . . . . . . . . . . . . . . 10
Administrative Considerations . . . . . . . . . . . . . . 10
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COMPLIANCE STRATEGY TSCA Section 8(d)
Overview -
Section 8(d) of the Toxic Substances Control Act (TSCA) provides
that EPA shall require by rule that manufacturers, processors and
persons proposing to manufacture or process specified chemical sub-
stances or mixtures submit lists and copies of health and safety
studies which have been conducted on these selected chemicals. The
Agency published a final rule at 47 FR 38780, September 2, 1982, to
implement the §8(d) requirement for a specified list of chemicals.
The chemicals have been recommended by the Interagency Testing Com-
mittee (ITC) and independently selected by EPA for evaluation. The
acquisition of studies on the specified chemicals is intended to
aid EPA in evaluating their health and environmental effects. The
reported information will also be used to determine whether the
chemicals should be included in testing rules issued under §4 of
TSCA. The Agency intends to use the same rulemaking authority to
collect information on additional chemicals in the future.
This document contains the Agency’s strategy for monitornig
compliance with the §8(d) rule. It discusses the regulatory require-
ments, compliance monitoring priorities, and allocation of responsi-
bility between Headquarters and the Regions.
Regulated Industry
The §8(d) reporting requirement is expected to affect approxi-
mately 650 manufacturers and processors of the chemicals listed in
§716.17 of the rule as well as those persons who propose to manu-
facture or process a chemical listed. This number will fluctuate
with additions and deletions to the list.
Requirements of the Rule
Section 8(d) of TSCA (15 U.S.C. 2607(d) authorizes the
Administrator to promulgate rules which require the submission
of lists and copies of health and safety studies on chemical sub-
stances or mixtures.
Who must report
Those subject to this reporting requirement include persons
who currently manufacture or process any listed chemical substance
or mixture for commercial purposes, those who propose to do so,
and those who are not currently involved with a listed chemical but
who manufactured or processed it or proposed to do so any time
during the ten year period prior to the time it became listed. It
should be noted that while the reporting requirement extends only
to those persons who are engaged in these activities for “commercial
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purposes,” EPA interprets this term broadly. “Commercial purposes”
refers to activities conducted by an entity which have as their
purpose, in whole or in part, the obtaining of a commercial advan-
tage. Lhis definition is intended to exclude only those activities
which are of a strictly charitable or purely academic nature. The
term is not meant to exclude those manufacturers and processors
who create a chemical substance as a co—product or by—product in
their manufacturing process.
What chemicals/mixtures are subject to the rule
The rule (40 CFR §716) applies to all chemical substances
selected by the ITC as well as other chemicals separately selected
by EPA. The ITC, established under §4(e) of TSCA (15. U.S.C.
2603(e)), has recommended the chemical substances and mixtures
subject to this rule for priority consideration by EPA in the
issuance of testing rules under §4(a) of ISCA. Under §4(e), the
ITC is directed to revise the list every six months as it deems
n e c e S S a ry.
What must be reported
Under the rule, manufacturers and processors are required to
submit copies of all completed health and safety studies within
their possession, as well as a list describing any ongoing studies
and studies known to the respondent. Persons who are not involved
with a chemical when it is listed but manufactured or processed it
or proposed to do so any time during the ten years prior to the
time it is listed, are required to submit copies of studies for
that chemical, but are not requtred to list studies.
Any person in possession of a study may be required to submit
it. The rule, however, limits the initial submission of studies
to manufacturers or processors of chemicals or those persons who
propose to manufacture or process a listed chemical. The rule
further limits the file search to studies in currently active
files. For purposes of this rule, persons do not have to search
files retired prior to December 31, 1979. Other persons in posses-
sion of studies would submit them only upon request by EPA after
the studies had been listed by the initial group of submitters.
Copies of studies
Persons subject to the rule must submit all non—exempt health
and safety studies in their possession within 60 days after the
effective date of the placement of a chemical on the list. For
chemicals appearing in the FR Notice of September 2, 1982 the
reporting date is December 3, 1982. Included in this requirement
are all those studies which were conducted or initiated by or for
any manufacturer or processor and are in that person’s possession.
Similarly all those studies which were conducted or initiated by
a person who is not subject to the requirements of this section
must be submitted if the study is in the possesssion of a manuf-
acturer or processor subject to the rule
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-3—
Lists of studies
The rule requires respondents to submit a descriptive list of
all ongoing health and safety studies conducted by or for them within
60 days of the placement of a chemical on the list. For chemicals
appearing in the FR Notice of September 2, 1982 the reporting date
is December 3, 19S2. The purpose of the study, the type of data
collected, and the anticipated date of completion for each study
must be included. The EPA may ask persons who list studies to submit
all or part of any report including preliminary reports or underlying
data. In such cases, the Agency will notify the respondent by
certified mail. After the initial 60—day reporting period, persons
are only required to list chronic tests; long- and short—term tests
of mutagenicity, carcinogenicity or teratogen-icity, and the biological
and environmental fate tests listed in §716.10(h) through Ci).
Excluded Reporting
To avoid duplication, the rule provides for the exclusion
of information which has been previously reported. The following
information is specifically exempt from the reporting requirements
of §716.6 and §716.7:
0 studies or data which have been published in scientiftc
literature
o studies which have been submitted to EPA or studies
submitted to any other Federal agency without claims of
confidentiality
o studies conducted or initiated by or for another person
who is subject to the requirements of the rule
o studies of chemical substances which are not on the
TSCA Chemical Substance Inventory
° studies of substances or mixtures in which a substance
or designated mixture listed in §716.17 appears only
as an Impurity. When reporting is to be required on
a substance or designated mixture that appears as an
impurity, that reporting will be separately proposed
in the Federal Register .
° copies or lists of the following types of studies
when the subject of the study is a mixture containing
one or more chemical substances or designated mixtures
listed in §716.17.
— Acute oral toxicity studies
— Acute dermal toxicity studies
— Acute inhalation toxicity studies
— Primary eye irritation studies
— Primary dermal irritation studies
— Dermal sensitization studies
- Physical and chemical properties except
those listed in §716.10
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-4-
° copies or lists of analyzed aggregations of monitoring
data which was acquired up to 5 years preceding the
placement of the chemical substance or designated
r 1jxtIJre on the list in §716.17 or when such monitoring
data was not analyzed to determine the exposure or
concentration level of the listed chemical substance
or designated mixture.
o analyzed aggregations of monitoring data on mixtures
known to contain one or more substances or designated
mixtures listed in §716.17, when the monitoring data
are not analyzed to determine the exposure or concen-
tration levels of the substance or designated mixture
listed in §716.17.
Additionally, §716.6 states that the underlying data need not
be submitted unless requested. The rule specifies certain proce-
dures to he followed when submitting information.
Ho to Report
Submission of Copies of Studies
Each study submitted under §716.6 must be accompanied by a
cover letter containing the following information:
name, address, job title, and phone number of the
submitting official
O the name and address of the company on whose behalf the
study was made
o the—identity of any impurity or additive known to have
been present in the substance as studied unless its
presence is specifically noted in the study.
Submissions under this section must be indexed by chemical
name, Including the Chemical Abstracts Services (GAS) Registry
tlurnber, if known.
Submission of Lists of Studies
Lists submitted under §716.7 must include:
° Ongoing health and safety studies conducted by or for the
manufacturer Including the purpose of the study, type of
data collected, and progress and anticipated date of corn—
p1 eti on.
° Study title, and the name and address of any person whom
the respondent knows is in possession of any unpublished
studies which are not in the respondent’s possession.
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—5—
The lists submitted under 7l6.7 must he grouped by
chemical, including CAS number, if known, and must be accompanied
cover letter. The cover letter must contain the, name, job
title, address and telephone number of the subnii tti ng official
and the name and address of the manufacturer or processor with
which the official is associated and on whose behalf submission
is made.
Reporting Timetable
All submissions under 55716.6 and 716.7 of the rule must be
postmarked on or before 60 days after the effective date of the
listing of each chemical in §716.17 or within 60 days of proposing
to manufacture or process a substance or designated mixture if
first done after the effective date of the substance’s or design-
ated mixture’s listing in §716.17. However, a request for an
extension may be granted in the event the file search is expected
to be lengthy. Because the duty to report is a continuing one,
all those persons who are required to submit lists of studies
under §71 6.7 must inform EPA of any study initiated during the
three year time frame commencing on the date on which the chemical
substance or mixture was added to the list in §716.17. Copies of
final reports of studies listed as ongoing under §716.7(a)(i.) or
studies initiated within the three year reporting period must be
submitted to EPA within thirty days of the date they are obtained
by persons required to report.
The rule also contains a sunset provision which provides
that within three years after a chemical substance or mixture is
added to the list in §716.17, the reporting requirement on that
substance will terminate. If EPA determines that reporting on a
specific chemical should be continued, a notice to that effect
will be published for comment.
Confidentiality Claims
Anyone submitting §8(d) information may claim all or part
of the material as confidential. Claims must be made at the
time of submission and two copies of the material must be
submitted; one a complete copy and one copy with confidential
material deleted. Claims of confidentiality must be in
accordance with §716.16 of the rule.
Enforcement Objectives
The major objective of this strategy for monitoring compliance
TSCA requirements to submit health and safety studies, is (1) to
use limited resources most effectively to detect violators and (2)
to provide further incentive for compliance with this rule.
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Voluntary Compi lance
The rule precludes the effective use of an affirmative compli-
ance program as an enforcement tool because generally it is only
after EPA is informed of the existence of studies that measures can
be taken to insure disclosure. Therefore, for effective enforcement
of the rule, It is essential that industry be well informed of its
requirements. Not only should enforcement efforts be directed
towards informing industry of its obligation to report all non—exempt
studies within its possession, but also of the requirement to submit
lists of any studies of which it is aware. The current outreach
program developed by OTS includes:
1. Notification to industry that the rule was been
promulgated and that compliance must occur with-
in 60 days. A summary of the rule’s requirements
was included in the notice.
2. Notification to industry if and when additional
chemicals are added to the list in §716.17 of
the rules.
Types of Violations
Five potential violations of the §8(d) requirements in order of
priority are:
o Falsification of data
o Failure to submit copies
o Failure to submit lists
o Failure to report on time
o Failure to follow prescribed reporting procedures
Violati on Detection
Falsification of Data
Data falsification seriously threatens the Agency’s efforts to
evaluate a substance’s environmental and health effects. Violations
of this sort are detected by analyzing data submitted to OTS. While
the likelihood of detecting data falsification is smaller than detec-
ting other types of violations, any case of suspected data falsifica-
tion will be given highest priority.
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Failure to Submit Copies of Studies
The submission of copies of studies conducted on chemicals
which appear on the list is essential to EPA in §4(a) rulemaking.
The submission of health and safety studies will aid PA in its
determination of whether sufficient data exists upon which to base
an evaluation of the substance’s environmental and health effects.
If sufficient data exists, there will be no need for the promulga-
tion of a rule requiring further testing under §4(a). Therefore,
industry, through timely submission of existing studies, could
partially or in some instances totally obviate the need for further
testi fly.
Failure to Submit Lists of Studies
The rule sets forth essential reporting requirements as
described below. The degree of violation associated with each
requirement reflects the detriment to §4(a) rulemaking created by
the failure to report.
° The submission of lists to EPA of all health and safety
studies which are currently in progress will assist EPA
in formulating a complete and accurate analysis of the
need for further testing on a particular substance.
Failure to submit such information may lead to a duplica-
tion of testing as well as an increased administrative
burden in uncovering these studies upon their completion.
0 Respondents must submit the names of persons who they know
possess unpublished health and safety studies. Such lists
are essential to the discovery and location of these .docu—
ments. Additionally, these lists may serve s a means of
identifying those persons who have failed to submit copies
of the listed studies to the Agency as required by the rule.
The lists may also be used to solicit copies of these studies
from those persons who are not required to submit unless so
requested by EPA.
Failure to Report on Time
The timely submission of health and safety studies is essential
to efficient rulemaking under TSCA. Industry may fall to submit
adverse health and safety studies in a timely fashion in an effort
to delay eventual regulation of a chemical substance. The f 1 ilure
to inform EPA as to the existence of relevant studies within 60 days
after the effective date of the listing of a chemical could result
in the initiation of unnecessary rulemaking procedures.
Failure to Follow Prescribed Reporting Procedures
Generally, the EPA will not impose a civil penalty for minor
failures to follow the prescribed reporting procedures. If, however,
such a failure impairs the Agency’s ability to adequately evaluate
the sufficiency of health and safety data which is available on a
particular chemical, it will be considered a failure to report or a
failure to report on time, as appropriate.
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Application of Detection Methods
The purpose of TSCA §8 is to help’ the Agency gather information
about chemicals that may pose hazards to either human health or the
environment. The §8(d) rule requires manufacturers and processors
of specified chemical substances to provide the Agency with copies
of health and safety studies in their possession and lists of
studies conducted for them. The objective of §8(d) is to allow
the Administrator to make informed decisions regarding the need
for §4 ISCA testing.
Although compliance with the §8(d) rule is important to the
Agency, EPA aoes not intend to conduct an extensive affirmative
compliance monitoring program. The Compliance Monitoring Staff
(CrIS) feels that industry will voluntarily comply with the §8(d)
requirements for two reasons. First, §8(d) does not require anyone
to initiate health or safety studies. Persons subject to the
regulation must only submit copies or lists of existing studies.
Thus, the cost to industry of complying with §8(d) is low.
Second, an economic incentive exists for industry to comply
with §8(d). Most of the chemicals subject to §8(d) have been
selected by the Interagency Testing Committee (ITC) or referred
by EPA for priority testing under TSCA §4(a). Section 4 grants
authority to the Agency to require industry to conduct and pay
for health and safety studies. In essence, §8(d) allows industry
to avoid §4 testing if it can supply existing health and safety
studies for ITC chemicals. Therefore, the Agency expects
compliance from industry to avoid costly duplicative §4 testing.
The CMS will, of course, conduct inspections to detect
violations of §8(d) if allegations are received from third parties.
In addition to inspections conducted in response to allegations
received, §4 Good Laboratory Practices (GLP) inspections could be
used to review specifically targetted §8(d) studies or studies which
may contain §8(d) data.
For effective, responsive enforcement, EPA must obtain infor-
mation as to the existence of health and safety studies held by
industry. Potential sources which OTS and CMS can use to discover
§8(d) violations include the following:
o reports from employees of manufacturers, processors
and distributors of chemical substances involved In
the generation of such reports,
o reports from contractors/consultants who conducted
health and safety studies for manufacturers, pro-
cessors and distributors,
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o competitors who are subject to the requirement of §8(d) ,
o §4 GLP inspections , and
O compliance investigations
Reports from employees
Employees of a firm subject to the reporting requirement may
become aware that health and safety studies are being withheld from
government scrutiny. Generally, this would involve those employees
who either participated in or conducted the study itself. Industrial
hygienists should be apprised of the requirements of the rule to
improve communications in this area.
Reports from employees may come into Headquarters or the Regions.
EPA will conduct follow up inspections since such reports alone will
not be sufficient to substantiate a violation without further investi—
gati on.
Reports from contractors
Health and safety studies often are performed by persons who
are contractors rather than employees of firms subject to the
§8(d) requirement. Although these contractors are not subject to
the §8(d) requIrement, they may notify EPA if they become aware
that the results of their studies have not been reported to the
Agency. Similarly, purely academic and charitable institutions
who are not subject to the reporting requirement of the rule may
provide EPA with lists of studies which they have performed for
industry. EPA will notify labs appearing on the §4 list of testing
labs of the requirements of §8(d).
Reports from competitors
Under the rule, each person who manufactures or processes the
selected chemical substances or designated mixtures listed in
§716.17 must report all health and safety studies known to him or
reasonably ascertainable by him. While this rule specifically
excludes the submission of copies or lists of studies conducted
or initiated by another person subject to the rule, it is reasonable
to assume that there will be some overlap in the listing of studies
by persons subject to the rule. Through this reporting overlap,
EPA may learn of the existence of studies which have not been dis-
closed to the Agency. The OTS can either request or have CMS
subpoena a copy of the health and safety study from those persons
I denti fi ed.
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§4 GLP Inspections
Data reviewed in the course of a §4 GLP inspection may
be data which is required to be submitted under §8(d). Inspectors
should compare the list of studies the lab is currently performing
with the chemical list in §716.17 to determine whetherthe lab is
testing a chemical on the list. If an inspector encounters any data
which would be required to be submitted under §8(d), the inspector
should list the study title, chemical involved, who the study was
conducted for, and the name of the person within the company who
coordinated the study. This information should be transmitted to
CMS Headquarters who will turn it over to 015.
Compliance Investigations
The most effective use of investigation as an enforcement tool
under §8(d) is as a responsive measure to the reports enumerated
above. Reports should in all cases trigger further investigation
rather than form the sole basis of enforcement action. These respon-
sive inspections are preferable to neutral administrative inspections
because responsive inspections focus resources on studies which are
most needed by the Agency. The precise nature of each investigation
may vary with the alleged violation.
Priorities
The major function of §8(d) is to insure that the Agency obtains
all the existing health and safety studies on the listed chemicals.
This is essential to insure that EPA is apprised of all data prior
to its assessment of the need for further testing. To maximize
enforcement efforts, those compliance monitoring activities aimed
at detecting failure to report violations should be given first
priority under this rule. The CMS should conduct compliance moni-
toring activities in the following order of priority to insure
maximum discovery of violations:
o Response to Evidence of Failure to Submit or Falsification
of Copies of Studies
o Response to Evidence of Failure to Submit Lists of Studies
Other violations will be pursued as the need arises, primarily
as the result of referrals from OTS.
Administrative Considerations
Allocation of Responsibilities
Office of Toxic Substances
The Office of Toxic Substances COTS) will
o Be responsible for determinations of the lateness of
a report or of the failure to submit a report and for
transmitting their determination to CMS.
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Be responsible for analyzing data received for possible
falsi fication.
o Be responsible for determinations of whether prescribed
reporting procedures had been followed.
° Assist in the preparation of a subpoena when necessary.
O Provide CMS with current lists of chemical substances
or mixtures subject to §8(d) reporting.
Compliance Monitoring Staff
The CMS will:
o Act as liaison with OTS, OLEC and Regions.
o Schedule any necessary inspections upon consultation
with the Regions.
o Assist in preparation of a subpoena when necessary.
o Provide Regional Offices with current lists of chemical
substances or mixtures subject to §8(d) reporting.
Office of Legal and Enforcement Counsel
The Office of Legal and Enforcement Counsel (OLEC) will:
o In conjunction with CMS and Regional Counsel, deter-
mine whether the evidence in a case is sufficient to
issue a complaint.
o Assist in the preparation of a subpoena when necessary.
Regional Offices
Regional Offices will:
o Transmit any allegations received to CMS for action.
o Participate in field inspections, when necessary.
o In conjunction with Headquarters, prepare and serve any
subpoena.
o Issue complaints and carry out any resulting adminis-
trative litigation or settlement.
Responsibility for responsive compliance monitoring activities
under the §8(d) rule will be shared by Headquarters and the Regions.
Section 8(d) investigations will be initiated by a team with repre-
sentation from Headquarters OTS, CMS and OLEC and the appropriate
Region(s). The team will recommend inspections if necessary, which
will be performed by Regional inspectors.
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In instances where the OTS refers a potential §8(d) case to
CMS for action, CMS will in cooperation with the Region and OTS,
investigate the allegation. The CMS will then consult with OLEC
and Regional counsel to determine whether the evidence is sufficient
to issue a complaint.
Any report of a violation received by a Region should be trans-
mitted along with any available documentation to the CMS before
further action is taken. The CMS will contact OTS for analysis of
any documentation and to arrange for 015 participation in any further
investigation. CMS will schedule any necessary inspections. The
CMS will consult the OLEC and Regional Counsel to determine whether
the evidence is sufficient to issue a complaint. If a subpoena is
necessary to obtain data, Regional Counsel will prepare it in con-
junction with the OTS, OLEC and CMS. The OTS will be responsible
for analyzing the data received in response to the subpoena.
In all cases the Regions will issue complaints and be respon-
sible for resulting administrative litigation or settlement.
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COMPLIANCE STRATEGY FOR THE TSCA §5 (h)(4) PREMANUFACTURE
NOTICE EXEMPTION FOR CHEMICALS USED IN OR FOR INSTANT
PHOTOGRAPHIC OR PEEL-APART FILM ARTICLES
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COMPLIANCE STRATEGY FOR THE TSCA S5(h)(4) PREMAIIUFACTURE
NOTICE EXEMPTION FOR CHEMICALS USED IN OR FOR INSTANT
PHOTOGRAPHIC OR PEEL-APART FILM ARTICLES
OVERVIEW
Under section 5(h)(4) of the Toxic Substances Control Act
(TSCA). EPA may, upon application and by rule, exempt a new chemical
substance from some or all of the section 5 premanufacture notice
requirements if the Administrator determines that the substance
will not present an unreasonable risk of injury to health or the
environment. On June 4, 1982, the Agency published a final rule
at 47 Federal Register 24308 (40 CFR Part 723). This rule is an
exemption under TSCA section 5(h)(4) from the premanufacture notice
requirements of section 5(a)(1)(A) for the manufacture and process—
fng of new chemical substances used In or for the manufacture or
processing of Instant photographic and peel—apart film articles
under certain conditions. These conditions include: (1) submission
of an exemption notice when manufacture begIns, (2) compliance with
certain requirements to limit exposure, and (3) compliance with
recordkeeping requirements found in the rule. The exemption is
limited to the manufacturers of Instant photographic or peel—apart
articles who manufacture and process new chemical substances used
in or for the manufacture or processing of these articles. A
peel-apart film article containing a new chemical substance may
not be distributed in commerce or used until a premanufacture
otice under section 5(a)(1)(A) is submitted and the review period
nas ended. The effective date of the rule is July 6, 1982.
A new chemical substance manufactured under the terms of the
exemp.tion will not be added to the TSCA Chemical Substance Inventory..
However, a firm may elect to submit a premanufacture notice (PMIJ)
for a chemical covered by the exemption, and the chemical will be
placed on the inventory after the notice review period ends and
manufacturing begins unless EPA takes action, such as Issuance of
a section 5(e) or section 5(f) order.
Only two firms are believed to be eligible at present for this
exemption. Inspections to insure compliance with this rule will
be incorporated into the section 5 inspection program.
Failure to comply with the terms of the exemption constitutes
a violation of section 15(1)(B) which provides that noncompliance
with a section 5 requirement or rule is unlawful.
REQUIREMENTS OF THE RULE
Aopl i cabil I ty
This rule establishes the conditions for an exemption from
MN requirements. In order to manufacture or process a new
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chemical substance used In or for instant photographic film
articles, a manufacturer has the option of complying with the
exemption or submitting a premanufacture notice for the specific
c ical to EPA 90 days prior to manufacturing or processing the
n chemical substance.
This exemption applies only to manufacturers of instant
photographic or peel—apart film articles who:
1) manufacture the new chemical substances used in or
for the manufacture or processing of the Instant photo-
graphic or peel-apart film articles;
2) submit an exemption notice when manufacture begins;
3) limit manufacture and processing of a new chemical
substance to the site(s) listed in the exemption notice;
4) comply with conditions of the exemption in paragraphs
(e), (f), (g), (h) and Ci) of section 723.175; and
5) do not distribute in commerce or use a peel—apart film
article containing a new chemical substance until sub-
mission of a premanufacture notice under section 5(a)(1)(A)
of the Act and until the review period for the notice has
ended without EPA action to prevent distribution or use.
o -e Requirement
A notice must be submitted to EPA when manufacture of the new
chemical substance under the exemption begins. Table I lists the
information which must be included in the notice. The notice must
be addressed to the Document Control Officer (TS—793), Office of
Pesticides and Toxic Substances, EPA. 401 M St. S.W., Washington,
D.C. 20460.
P eauirecnents to Limit ExDosure
All manufacturing, processing, and use operations involving
the new chemical substance must be performed in a demarcated,
soecial production area under the conditions found in Table II
until the substance has been incorporated into a wet mixture,
hotographic article, or instant photographic or peel—apart film
article.
The following activities are allowed outside the special pro—
1uction area provided the conditions given in Table II for these
activities are met:
1) Removal of the new chemical substance from the special
production area for storage between operational steps or
for transportation to another special production area.
723.175(e) (8)
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—3—
2) Incorporation of a wet mixture containing the new chemical
substance into a photographic article or instant photo-
graphic or peel-apart film article. 723.175(f)
3) Incorporation of a photographic article into the, instant
photographic or peel—apart film article. S723.175(g)
Although labeling is required for removal or transportation of the
new chemical substance from the special production area, no label-
ing is required If the substance has been incorporated into a
photographic article, or if It is contained in a sealed reaction
vessel or pipeline, or if it has been Incorporated Into an instant
photographic or peel—apart film article. While the rule does not
specifically exclude wet mixtures from labeling, the intent was
that labeling not be required for wet mixtures.
Other Requirements
Other conditions of the exemption relate to environmental
release, waste treatment, and recordkeeping. These requirements
are given in Tables III and IV. In addition to maintaining the
records listed, the manufacturer must make the records available to
EPA upon written request by the Director of the Office of Toxic
Substances (OTS). These records must be provided within 15 working
days of receipt of the request. This in no way relieves the manu-
facturer from having to make these records available during inspec-
tions conducted in accordance with TSCA section 11.
P EIIDMEUT MID REPEAL
The regulation provides for amending or repealing any term of
the exemption by formal rulemaking i F’ EPA determines that activities
under the exemption may present an unreasonable risk. EPA may also
amend the exemption to enlarge the category or reduce the restric-
tions. Furthermore, the Director of the Office of Toxic Substances
may prohibit the use of the exemption if he or she determines that
the manufacture, processing, distribution in commerce, use or
disposal of the substance may present an unreasonable risk. This
prohibition can be accomolished without formal rulemaking.
723 .175( in)
REGULATED INDUSTRY
The regulated industry consists of those companies who 1) inanu-
facture or process a new chemical substance used in or for instant
photographic or peel—apart film articles and 2) manufacture the
article and 3) submit an exemption notice. EPA is aware of only
two companies which meet the first two requirements — Polaroid and
Eastman Kodak. Therefore, they are the only two companies expected
to be eligible for the exemption. Each of these firms has several
ites where chemicals may be manufactured under the exemption.
ie designation of the location of manufacturing sites is required
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-4-
in the exemption notice.
— N F 0 R C E ME N T
NF0RCEMENT GOALS
The goal is to assure compliance with the terms of the exemption.
VIOLATIONS
NOTICE VIOLATIONS
Withholding material information or submitting false or
misleading information.
Failure to file an exemption notice when other exemption condi-
tions are met.*
Late notice.
(*Fajlure to file a notice when other exemption conditions are
not met is a PMPJ violation rather than an exemption violation.)
0 EXPOSURE LIMITS
Exceeds exposure limits, as determined by EPA’s monitoring.
Exceeds exposure limits, as reflected by company’s records.
Failure to take steps to limit exposure.
o MONITORING
Failure to monitor.
Failure to monitor properly, e.g., unsuitable sample methods,
incorrect intervals, improper location.
0 E JGINEERING CONTROLS & EXPOSURE SAFEGUARDS
? o engineering controls and exposure safeguards used where
requ i red.
Inadequate engineering controls and exposure safeguards used
where required.
4o labeling where required.
Improper or incomplete labeling where required.
0 RESPIRATORY PROTECTION
Proper respirators not provided for individuals in Special
-------
—5—
Production Area (SPA).
Respirators not worn by Individuals in SPA.
‘Quantitative fit test not performed.
0 TRAINING
Plo training program.
Not all required individuals attend.
Inadequate/incomplete training program.
o HYGIENE
Appropriate facilities for changing and washup not provided.
Food, beverages, tobacco products, or cosmetics allowed in
SPA.
Inappropriate standards of hygiene which do not limit exposure.
WORK PRACTICES
Improper spill/release control.
Written procedures for responding to emergency situations not
fmrnediately accessible to employees •in SPA.
•laterials for emergency situations not immediately accessible
to employees in SPA.
Practices do not limit exposure to appropriate level.
Spills or unanticipated releases of a wet mixture not controlled
by trained personnel wearing appropriate protective clothing and
equl pment.
0 PERSONAL PROTECTION DEVICES
Improper clothing or equipment.
0 CAUTION SIGNS
No signs.
Improper signs.
0 ENVIRONMENTAL RELEASE AND WASTE TREATMENT
Waste not handled as hazardous waste.
Iastewater or discharge not pretreated.
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—6—
Wastewater or discharge not properly pretreated.
Process emissions not vented through appropriate control
devices.
RECORDKEEPING
Records not kept.
Records incomplete.
o RECORDS SUBMISSION
Records not submitted.
Records not submitted on time.
o PROHIBITION
Prohibition violated.
o AMENDMENTS
Violation of an amendment.
There have been no amendments at this time.
INSPECTIONS
1eutral Administrative Inspection Scheme
All sites where chemicals are being manufactured/processed
or records are kept under this exemption will be inspected on a
periodic basis. The Region should inspect each site after an
initial exemption notice is submitted for that site, preferably
within 120 days after the notice is submitted. If no violations
are found, the Region should inspect again approximately one year
from the date of the first inspection. If no violations are
found during the second inspection, then the Region should re-
inspect each site approximately every two years.
If violations are found, the Region should reinspect the site
within 120 days. This should continue until two consecutive inspec-
tions are conducted and no violations are found. After that, the
Region should inspect the site approximately every two years.
Inspections may also be conducted at other companies/sites
based on tips or referrals.
Scheduling Inspections
Prior to scheduling inspections, the Region should contact
the company to discuss when the exempt chemicals will be manu—
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—7—
factured, where the records are kept, and a time frame as to
when EPA could inspect. A specific inspection date need not
be arranged with the company. Unannounced Inspections are
considered desirable to assure compliance with this exemption.
ADMINISTRATIVE CONSiDERATIONS
Allocation of Responsibilities
Office of Toxic Substances
The Office of Toxic Substances will:
1. Review the exemption notices.
2. Have the Management Support Division make two copies of
the exemption notice and other relevant Information,
Including the name and phone number of the Notice Review
Manager and a statement of any 01$ questions or concerns,
and notify the Document Control Officer In the Pesti-
cides and Toxic Substances Enforcement Division (PISED)
within 15 working days after receipt of an exemption
notice that the documents are available.
3. Have the Notice Review Branch provide the Management
Support Divisio.n with the information referenced in #2.
4. Provide technical support to PISED and to the Regions
when needed via PTSED.
S. Designate a contact person(s) to participate at PTSED’s
request in the review of inspection reports or case
files involving possible violations of the exemption.
6. Provide expert witnesses as needed.
Pesticides and Toxic Substances Enforcement Division (PTSED )
The Pesticides and Toxic Substances Enforcement Division will:
1. Forward copies of the exemption notices to the Regions
including technical information relevant to the individual
notices and any 01$ concerns.
2. Provide technical support to the Regions, including guidance
for conducting inspections and coordinating with OTS and
the Office of Legal and Enforcement Counsel (OLEC) to
resolve technical or legal questions.
3. Review inspection reports and keep OTS informed regarding
compliance with the exemption regulation.
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-8-
4. Rev concur on c lvii cases prepared by the Regions.
Thisudes forwarding the cases for concurrence to OLEC
as red.
5. Coor other TSCA inspectional activities with
this ram.
6. Arra, r expert witnesses.
7. Make itmendations to OTS regarding amendments, repeal,
or pritlon of use of the exemption.
Regions
The Regio,j :
1. Contac e company after receiving a copy of the exemp—
tior, n:e from PTSED to determine when the exempt
chemic 4 jli be manufactured, where the records are
kept, •a time frame for inspection.
2. Scheduinspections based on the neutral administrative
Inspect scheme in this strategy.
3. Perfor e inspections and.gather evidence.
4. Send a irtesy of the inspection report to the
Complja Monitoring B.ranch of PTSED.
5. Prepare,sultant civil cases and litigate such cases.
(CrImfn cases are to be handled according to guidance
issued bOLEC concerning TSCA criminal cases.)
Program Integratl 1
During an In ctjon to determine compliance with the exemption,
the Inspector shoud also inspect for compliance with other TSCA S5
requ1rem 5 Prir to conducting an inspection to verify compliance
with the exemption the Region should contact PTSED regarding other
TSCA 5 SUbmissfan actjvjtjes of the company.
- Through the Co pl jance monitoring activities related to the
enforcement of TSCASS, the inspector may obtain compliance monitor-
ing information fnv)lving other EPA enforcement programs. For
example, an fnspectar may turn up violations relating to other
parts of TSCA or of the water, air, or solid waste pollution control
regu1a 0 5 Thus, it is important for all those involved in
Section 5 enforcement to Communicate non—Section 5 compliance
monitoring informatj 0 to the appropriate office in EPA.
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TABLE I
INFORMATION REQUIRED IN THE EXEMPTION NOTICE
1. NAME OF MANUFACTURER — S723.175(l)(1)(i)
2. SITES AND LOCATIONS WHERE THE SUBSTANCE WILL BE MANUFACTURED
AND PROCESSED — S723.175(fl(1)(1)
3. CHEHICALIDENTITY—S723.175(i)(1)(ii)
4. IDENTITY OF IMPURITIES REASONABLY ANTICIPATED
§723 .175(1) (1) (iii)
5. DESCRIPTION OF PHYSICAL AND CHEMICAL PROPERTIES
§723.175(1) (1) (iv)
6. IDENTITY OF BY—PRODUCTS AND VOLUME OF EACH — §723.175(i)(1)(v)
7. ESTIMATE OF ANTICIPATED MAXIMUM ANNUAL PRODUCTION VOLUME
723.175(1) (1) (vi)
8. ALL INFORMATION AND TEST DATA ON THE NEW CHEMICAL SUBSTANCE’S
HEALTH AND ENVIRONMENTAL EFFECTS THAT ARE KNOWN TO OR REASON-
ABL.Y ASCERTAINABLE BY THE MANUFACTURER — S723.L75(i)(1)(vil)
IDENTITY AND DESCRIPTION OF THE ARTICLE THAT WILL CONTAIN THE
THE NEW SUBSTANCE — §723.175( i)(1)(viii)
10. DESCRIPTION OF METHODS USED TO CONTROL AND TREAT. WASTEWATER
OR DISCHARGE RELEASED TO A P01W OR OTHER RECEIVING BODY OF
WATER. IDENTITY OF P01W OR OTHER RECEIVING BODY OF WATER.
§723.175(1) (1)( ix)
11. CERTIFICATION THAT THE MANUFACTURER IS FAMILIAR WITH AND
WILL COMPLY WITH THE TERMS OF THE EXEMPTION — §723.175(i)(1)(x)
A ROHYMS USED IN TABLES
P01W - Publicly Owned Treatment Works
TWA - Time Weighted Average
SPA — Special Production Area
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tkist monitor using suitable
sample method.
Monitor first 3 eIght-hour
work shifts involving the
manufacture or processinng of
each new chemical substance;
then. 1 eIght-hour shift per
month during production run
during period of maximum em-
ployee exposure. If in com-
pliance for 3 months, monitor
only every 6 months unless
there is a change In process,
process design, or equipment
(then begin monitoring again).
Samples must represent worker’s
breathing zone.
S723.175(e) (3)(A)
(See this section for details
of monitoring.)
F: II
REQU1R [ M [ t 1TS to LIMIT EXPOSURE
Periodic
monitoring same
as for SPA In
areas where it
is reasonable
to expect a
risk of Inhala—
tion exposure.
§723. 175(e) (10)
I
SPECIAL PRODUCTION AREA
(SPA)
I
AREA ADJACENT
TO SPA
I
REMOVAL FOR
STORAGE OR
I
I PROCESSING WET MIXTURES
OUTSIDE SPA
INCORPORATION
INTO ARTICLES
.
..
1.
POSURE
Air Concentration — TWA
Must not cx—
Must linilt
Must take mea—
MITS 10 ppm for gases and vapors
50 ug/m for particulates
Allowable TWA excursion of 50%
above for 30 mInutes or less.
I S723.175(e)(1)
ceed limit for I
waiver of res— I
pirator prot c I
tion in SPA. I
S723.175(e)(10)I
I
I
I
I
I
I
I
exposure.
S723.175(e)(8)
I
I
I
I
sures to limit
exposure dur—
ing operation
using engi—
neering con—
trols, train—
ing. hygiene.
work practice
and personal
protective
devices.
S723.175(g )
j
I
I
MITORING t
When suit-
able samp—
ling and
analytical
methods
exist.
‘crflr)flC nrnutncri rn nr ‘IaT’. -’..r-r
-------
Respirator required for each
Individual. Quantitative fit
test before first use.
Waiver If monitoring shows 8-
hr TWA of the new chemical
substance Is less than 1 ppm
for gases and vapors and 5
ug/m for particulates with
allowable TWA excursion above
for 30 minutes or less.
I 7?3.l1cre)i2I
TAL I
REQUIREMENTS TO LIMIT EXPOSURE
1 I
SPECIAL PRODUCTION AREA AREA ADJACENT
(SPA) TO SPA
REMOVAL FOR
STORAGE OR
TRANSPORTATION
PROCESSING WET MIXTURES
OUTSIDE SPA
I INCORPORATIOtI
INTO ARTICLES
ITORING*
hen suit—
ble samp-
ing and
nalytical
ethods
0 not
•xist.
A surrogate chemical substancel Same as for
possessing comparable physicall SPA.
chemical properties under I 5723.175(e)
similar manufacturing and pro-I (3)(B)
cessing must be used to assure$
compliance with exposure I
limits. I
5723.175(e)(3)(B) I
I
I
.
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
INEERING Controls and safeguards must I
‘TROIS & be used to ensure compliance I
OSURE with exxposure limits. I
EGUARDS 5723.175(e)(4) I
I
I
I
I
I
I
I
I I
I
I
________________ I
I
I labeling
I required. Must
I.include identi—
I ty or code,
I statement of
I any known haz-
ards, handling
instructions,
I firstaid I
information, I
spill control I
I directions, andi
I DOT notations. I
I 5723.175(e)(9) I
I
I
Must limit exposure, to I Controls and
the new chemical sub— safeguards
stance. must be used
5723.175(f)(1) to limit
exposure to
the new chem—
ical substance.
S723.175(g)
I
I
I
PIRATORY
‘TECT ION*
I
I I
I I
I I
I I
I I
I I
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TABLE II
REQUIREMENTS TO LIMIT EXPOSURE
SPECIAL PRODUCTION AREA
(SPA)
AREA ADJACENT
TO SPA
REMOVAL FOR PROCESSING WET MIXTURES
STORAGE OR I OUTSIDE SPA
TRAIl SPORTAT ION
INCORPORATION
INTO ARTICLES
INING Required before employee can
)GRAM* enter. Must cover known phy-
sical-chemical and toxicolo- I
I gical properties of chemicals I
I handled In the SPA, proceduresi
I for using personal safegaurds,I
hygiene, handling procedures,
emergencies, and spills.
S723.175(e)(5)(1) I
I
•
Required for employees
handling wet mixtures.
Must cover procedures for
using personal exposure
safeguards, hygiene,
handling procedures,
emergencies and spills.
S723.175(f)(2)(i)
.
‘
IENE Facilities for changing and
I washup must be provided. No
food, beverages, tobacco pro-
ducts, or cosmetics allowed
In the Special Production
I Area.
I S723.175(e)(5)(ii) I
Appropriate standards that
limit exposure must be
used by employees handling
the wet mixtures.
S723.175(f)(2)(iI)
I
Hygiene must
limit expo—
sure.
S723.175(g)
I 1• I
1 K I Must be designed to ensure
CTICES I compliance with exposure lim-
I Its. Spills or unanticipated I
I emissions must be controlled I I
by trained personnel wearing I
I suitable protective clothing I
I or equipment, such as chemi— -
cal—resistant coveralls, pro-
tective eyewear,and gloves.
Written procudures and all
materials necessary for emer— I
gency situations must be imme-I I
I diately accessible. I
I S723.175(e)(5)(i1t) I —
Must be designed to limit
exposure to the new chemi—
Ical substance. Spills
or unanticipated releases
must be controlled by
trained personnel wearing
protective clothing and,
where necessary, respira—
tors or chemically imper—
vious clothing.
S723.175(f)(2)(IiI)
Work practices
must limit
exposure.
S723.175(g)
ECORDS tJIRED TO BE MAINTAINED
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TABLE II
REQUIREMENTS TO LIMIT EXPOSURE
.
SPECIAL PRODUCTION AREA
(SPA)
I —
AREA ADJACEUT -REMOVAL FOR I PROCESSING WET MIXTURES
TO SPA STORAGE OR I OUTSIDE SPA
I TRAUSPORTATION I__________________________
I. I
INCORPORATIOII
INTO ARTICLES
ONAL
ECTION
CES
Workers In the SPA must wear
suitable protective clothing
or equipment, such as chemi-
cal-resistant coveralls, pro-
tective eyewear, and gloves,
§723.175(e)(6)
Workers engaged in the
processing of wet mixtures
must wear suitable protec—
tive clothing or equipment
such as coveralls, protec—
tive eyewear, respIrators,
and gloves.
S723.115(f)(3)
Personal pro-
tective de—
vices must be
used to limit
exposure.
§723.175(g)
10 1.1 Area must be clearly posted.
S Sign must restrict entry to
I trained personnel equiped with
appropriate personal exposure
safeguards.
§723.175(e)(7)
CORDS REQUIRED TO BE MAINTAINED
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TABLE III
ENVIRONMENTAL RELEASE AND WASTE TREATMENT
RELEASE TO LAND — S723.175(h)(1)
Process waste from manufacturing and processing operations In
the special production areas are considered hazardous waste
and must be handled In accordance with 40 CFR Parts 262
through 267 and Part 122 and Part 124.
o RELEASE TO WATER — S723.175(h)(2)
Wastewater or discharge must be pretreated before release to
a POTW or other receiving body of water. To release to a P01W,
pretreatment must prevent structural damage to, obstruction of,
or Interference with the operation of the P01W. For direct
release, treatment must be appropriate for the substance’s pro-
perties.
o RELEASE TO AIR — S723.175(h)(3)
All process emissions must be vented through appropriate control
devices.
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TABLE IV
RECORDKEEPING*
PRODUCTION RECORDS — 5723.175(j)(1)(i)
Annual Production yolume**
Date manufacture began
0 EXPOSURE MONITORING — 723.175(j)(1)(ti)
Record of all monitoring including:
Chemical Identity
Date of monitoring
Actual monitoring data for each monitoring location and
sampling
Reference to or description of collection and analytic
techniques
If cianufacturer does not monitor, records of reasons for not
monitoring and the methods used to determine compliance with
exposure limits must be kept.
0 TRAINING AND EXPOSURE RECORDS — §723.175(j)(1)(iii)
Records of worker’s participation in required training.
Records to demonstrate regular use of personal exposure safe-
guards, including results of personal exposure monitoring.
Results of quantitative fit test for respirator.
Any additional infornation related to worker’s exposure.
0 TREATMENT RECORDS — 723.175(j)(1)(iv)
Method of treatment If manufacturer releases treated wastewater
or discharge cbntaining a new c1 emical substance to P01W or
receiving body of water.
*Records must be kept for 30 years following the final date of
manufaacture.
**Although not required to-be kept by -the-regulatton,-lnforma—
tion as to the estimated annual sales volume should also be
requested by the inspector.
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0
-------
6EPA Enforcement Facts
and Strategy
d i
Polych tOri nated
B I phenyls
(PCBs)
-------
Enforcement Facts and Strate
Polych’orinated Biphenyls
Contents
Page
Swirary of Enforcement Strategy............................. 1
Background of the PCB Regulatlon............................
Regulated Industries....... ................................ a
Siminary of Regulatory Requlrements.......................... 4.
Violation Categories......................................... 5
Enforcement Objectives.... ... .... , ...... .. ......,.......... 6
Inspections...... .......................................... 7
Inspect ion Scheduling. . . ... .... . . . ............. . . .. . .. 8
Inspection Procedures. . ....... .... ... ....... ... ..... . .... . 9
Surtunary of PCB Penalty Pollcy............................... 10
Voluntary Compliance/Awareness Effort...............,....... 12
Sped al Programs.. . . .. ... . . . .. . .. .... . ... .. . . ... . . ... .. .. . 13
Allocation of Responsibi ities.............................. 14
-------
unvnary or ntorcement trateqy
The Pesticides and Toxic Substances Enforcement Division (PTSED) of
the Office of Enforcement, U.S. Environmental Protection Agency,
has developed a strategy to enforce the rule governing manufacture,
processing; distribution in commerce, and use of polychiorinated
blphenyl,s (PCBs) contained at 40 CFR 761. The rule includes
marking, storage, and disposal requirements.
The objective of the encforcement strategy is to ensure, through
an effective enforcement presence, that PCSs are properly disposed
of and that the risk of spills is reduced so that release of PCBs
to the environment will be limited to the greatest extent possible.
There are two main components of the strategy——inspections and
awareness.
The greatest enforcement effort will be spent in inspections. While
some effort will be devoted to Inspections in response to complaints,
crises, or special situations, major efforts will be devoted to
inspections of facilities in target groups which have been identified
as having significant numbers of PCB equipment. Scheduling of
1nspe tfons will be based on a neutral selection strategy which places
Inspectors in the faculties in those target groups where the greatest
response to inspection efforts can be expected.
During the inspec ions, facility records on PCB equipment, especially
transformers and large. capacitors, will be examined and verified. tn
addition, compliance with storage and marking requirements will be
monitored. Because of the potential release of PCBs from uncontrolled
discharges, special attention will be given during the Inspections to
examination of PCB equipment and the areas where they are located
for evidence of leaks or. spills.
Facility records will be used both to establish a working inventory
of PC3 equipment and to provide a check on any discrepancies in
storage and disposal accounts of such equipment. Evidence of dis-
crepancies In the year—to—year inventories, between the user 1 s and
disposer 1 s records, or between a physical inventory and the records
will be gathered through examination of records combined with a
physical verification of randomly—selected equipment.
The enforcement strategy also Includes an awareness component designed
to encourage good stewardship practices by the regulated community and
voluntary compliance with the PCB rule. The awareness effort will consist
of ensuring that menters of all industries with high numbers àf PCB
equipment are aware of the regulations and compliance requirements.
The serious view which EPA places on PCB violations, giving particular
emphasis to the Agency’s vigilance and sanctions against violators,
will be publicized. EPA’s willingness to help companies solve their
disposal problems will also be communicated.
-------
Background of the PC8 Wégu1ation -
Polychlorinated biphenyls (PCBs) have been used In the United States
since 1929. One of the most stable organic compounds known, their
properties make them useful as dielectric and heat transfer fluids.
They are widely used in transformers, capacitors, hydraulic systems,
and heat transfer systems.
Although PC3s have long been known to be extremely toxic, only In
recent years have they been acknowledged to be a general threat to
the environment. They have been found in significant concentrations
In waterways and sediments throughout the world. They are widely
spread contaminants of fish and wildlife resources. Recently, they
have been identified in the milk of nursing mothers throughout the
United States.
Extensive research has shown a link between PCBs and various health
effects including the formation of malignant and benign tumors, fetal
deaths, reproductive abnormalities, and mutations. In addition,
experiments have shown that PCBs attack the immunological system
and cause unwanted effect m the body’s production of enzymes.
I t t recognition of the risks associated with PCBs and their spread
throughout the environment, Congress mandated in the Toxic Substances
Control Act that the processing, distribution in commerce, user and
disposal of PCBs be regulated and that PCBs be marked with clear
and adequate warnings.
A rule governing the disposal and marking of PCBs became effective
April 17, 1978. A second rule, which incorporates the first,
imposes a ban on PC3 manufacturing, processing, distribution in
commerce, and use; it beca c effective July 23, 197.9. The
regulation can be found at 40 CFR 761.
Regulated Industries
At the present time, there are aver 500 million pounds of PCSs in
regulated uses throughout the economy. Almost all of these PCBs
are In use itt equipment which contains the chemical in an enclosed
manner, with the vast majority of PC3s contained in transformers and
large capacitors installed in the years between 1945 and 1975.
The primary manufacturer of PCBs ceased production of the chemical
In 1975.
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-3—
Over the next several decades, virtually all of this equipment will
be removed from service as ft wears out or fails. At this pofnt,
the PCBs and PCB—contaminated equipment will require disposal in
a way that prevents contamination of the environment.
Although improper final disposal of PCB transformers and capacitors
poses the greatest threat of extensive environmental exposure, PCBs
from In—service equipment and drums and tanks of PCB liquid now in
storage for disposal may present an iimnediate risk since the PCBs
could be released to the environment through leaks and spills.
SUch uncontrolled dischrages constitute Improper disposal also and
require containment and proper cleanup.
As stated earlier, the vast majority of PC3s are contained in
transformers and capacitors. Four major’economic sectors control
approxImately 90 percent of the 140,000 PCB transformers and 2.9
million capacitors now in service. Estimates for each kind of
PCB equipment by economic sector follow
Industrial : 51,000 transformers
.8 millIon large capacitors
(P B equipment is divided among industry
categories in the-following order of estimated
numbers: metals; chemical; paper and lumber;
mining; automobile; food; textile; and stone,
clay, and glass.)
Utilities : 38,000 transformers
1.3 million large capacitors
Camnercial Buildings : 34,000 transformers
1.3 million large capacitors
Railroads : 1,000 transformers
no capacitors
Since PC3 transformers and large capacitors, which contain the vast
majority of PCBs now In service, are so concentrated among these
sectors, they are the logical focus for enforcement activities
designed to encourage proper disposal of PCBs.
-------
Suimiary of Re uiatory Requirements
Following 4 s a suim ary of the major requirements of the PCB regulation.
The full text of the regulation is found at 40 CFR 761.
PC3 Ban Provisions (Reference: Section 761.30)
The following activities are prohibited:
a Distribution in coimnerce of PCBs and PCS items above 50 ppm
without an authorization or exemption.
o ProcessIng of PCBs or PCB items without an authorization or
-• exemption.
o Manufacture of PCBs without an exemption.
o Use of PCBs or PCB items without an authorization.
o Servicing of PCB transformers which requires removal of
the transformer coil.
Recordkeeping Requirements (Reference: Section 761.45)
Use of PCBs . Facilities that keep PC3 transformers or capacitors
must maintain annual records which show the following Items:
o Weights of PCBS in containers and transformers.
o Number of transformers and capacitors.
o Dates PC3s transferred.
o Quantities of certain PCBs and PCS items r aining in service.
Disposal of PCBs . PCB disposal and storage facilities must keep
annual records of:
o PCBs and PCB Items (number and type) received, including
address received from.
° PCBs and PC8 items (by type) stored, transferred, or disposed of,.
showing dates and weights.
o Operations of the disposal facility.
Marking Reauirements (Reference: Section 751.20)
The following items must be marked as containing PCBs:
o PCBs and PCB items containing greater than 50 ppm PC3s, except
PCB—contami nated transformers.
o Transport vehicles carrying more than 45 kg. of PCB liqui is over
50 ppm or with one or more PCB transformer.
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. 15 .I
Storage Requirements (Reference: Section 761.20)
Stored for Disoosal . PCB articles and PCB containers stored for
disposal must e stored in accordance with Annex III of 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 specifications
and time periods for temporary storage.
Disposal Requirements (Reference: Section 761.10)
- Above 500 ppm PCBs . PCB liquids and .PCB Items containing liquids
above 500 ppm PCBs must be disposed in:
o An EPA approved incinerator, or by
o Other disposal methods approved by the EPA Regional Administrator 1
Between 50 and 500 ppm PCBs . PCB liquids and PCB items containing between
50 and 500 ppm PCBs must be disposed In:
o An EPA approved landfill,
o An EPA approved high—efficiency boiler,
o An EPA approved incinerator, or by
o Other methods approved by the EPA Regional Administrator.
Uncontrolled Discharges . Any spill, leak, or other uncontrolled dis;harge
of PC3s constitutes improper disposal.
Violation Categories —.
Ban Provisions . This violation category Includes any manufacturing,
processing, or use of PCBs of PCB items without an appropriate
exemption or authorization. Also included are manufacturing, processing,
distribution, or use of PC s not complying witt the terms of an
authorization or exemption.
Recordkeeping . Violations of recordkeeping requirements Include
failure to keep required records at all, keeping records on only some
of the PCB Items subject to the requirements, keeping records that
contain Incomplete information, keeping inaccurate records, failure
to Initiate and maintain records in the required timeframes, and
falsification of records.
Marking . Violations of marking requirements include failure to mark
all or some of the PCB items subject to the requirement and marking
PCB items with a mark not meeting the required specifications.
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.6-
Storage . Violations in this category include storing the subject PCB
items in areas meeting none or only some of the specifications for
storage areas, storing items in containers not meeting specifications,
failure to date items placed in storage, and maintaining items’ in
temporary storage beyond the allowed time period.
Disposal . This category includes any disposal of PCBs not done In
accordance with the disposal requirements. Also included -in this
category is improper disposal caused by uncontrolled discharges
from PCB Items, such as from leaks or spills from in—service or
stored PCB Items.
Enforcement Ubjectives
Priorities in the PCB enforcement strategy are the logical outgrowth
of the overall objective, which is to minimize the release of PCBs
Into the environment, and thus the risk to human health and the
environment. In the strategy, inspections are scheduled among the
Industry categories which control the vast majority of PCBs and in
response to crisis or emergency ituations. The penalties assessed
against.facillties found in vl lation will be in direct relation
to the degree of environmentall hazard posed by the conditIon.
Together, the inspection strategy and enforcement policy will establish
the “enforcement presence” necessary to foster compliance throughout
the regulated comnunity.
PCBs can be released to the environment in two ways: (1) by improper
disposal of PCS items and liquids when they are no longer In use;
and (2) by uncontrolled discharge caused by leaks andspills from
In—service, stored, or transported Items. Both kinds of improper
disposal have the highest priority in the enforcement strategy.
Related, but of lesser priority, are those violations which increase
the likelihood of improper disposal, such as recordkeeping, marking,
and storage violations.
The potential for release of the largest quantities of PC i occurs when
a PCi transformer or large capacitor falls or Is otherwise taken out
of service. When this happens, the plant or facility operator must
decide whether to repair (transformers only) or- to dispose of the
equipment. In either case, the PCi materials must be disposed of.
When this disposal decision arises, one possible solution Is illegal
disposal, which would allow a significant quantity of PCSs to enter
the environment. It is at this point, then, that the most critical
violation may occur. An “enforcement presence” must exist at this
point to prevent such a violation from occurring.,
It Is difficult, however, to schedule enforcement activities so that
such disposal violations can be caught at the moment of occurránce.
To solve this difficulty, the enforcement strategy emphasizes records
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of PC8 use, storage, and disposal as an Indicator of compliance.
The requirement to establish and maintain records, and the possibility
of their inspection and verification, will establish the enforcement
presence necessary to achieve proper ultimate disposal 0 f the PCBs.
PCBs may also be released to the environment as a result of leaks and
spills from in—service, stored, or transported PCB items. Such
uncontrolled discharges constitute improper disposal and can pose a
significant risk to the environment if not contained and properly
cleaned up. Consequently, during the Inspections, the condition of
PCB items and the areas where they are located will be examined for
evidence of uncontrolled discharge. If violations are found, the
company may be subject to civil penalty assessment, and will be
required to undertake cleanup measures which could be very costly,
particularly if water or large surface areas have been contaminated
with PCSs.
Since civil penalties and cleanup costs are directly related to
the potential for environmental damage, the Inspection strategy
and enforcement policy should encourage companies to contain and
properly clean up spills at the time they occur and to take
preventive steps to minimize their liability In the event of an
uncontrolled discharge. Such preventive measures could Include
instituting regular equipment condition inspections; training
personnel In careful handling PCBs to reduce the risk of
accidents; and installing dikes or barriers around PCB items,
where appropriate, to contain possible PCB spills.
PC3 storage areas will receive an additional check to ensure
that they meet the specifications in Annex LII of the
regulations which were designed to minimize the potential for
environmental hazard from such areas. Also during the inspection,
compliance with PCB marking requirements will be monitored.
Unmarked PC3 items pose a risk to the environment because the
potential for improper ultimate disposal is significantly
Increased in the absence of a PCB warning label. Further, a
spill from an unmarked PCB item Is more likely to be cleaned
up In a manner which actually spreads the contamination or
exposes workers unnecessarily to the hazards of PCBs.
Inspections
The principal goal of the PCB enforcement strategy Is to influence
the regulated con T1unity Into making proper decisions regarding the
disposal of PC8 items and liquids no longer In use and to take steps
to minimize the potential for uncontrolled discharge from in—service,
stored, or transported PCB items and to contain and properly clean
up spills if they occur. The chief means for accomplishing this
goal is the scheduling of compliance inspections among the industry
categories which control the vast majority of PCBs so that an
enforcement presence is established.
-------
During the Inspections, compliance with requirements for marking,
storage, and use of PCBs will be examined while ensuring the
accuracy of PC3 records by verifying the existence of and proper
disposal of PCE equipment and liquids. Inspectors will also examine
the condition of PC8 items and the areas where they are located for
evidence of uncontrolled discharge.
The inspection scheduling technique described in the next section
Is the neutral administrative inspection scheme for PC3 enforcement.
A sunm ary of PCB lnspectlon.proceciures follows.
Inspection Scheduling
The general scheduling technique, which selects facilities that should
be inspected, relies on both the forecasted occurrence of upcoming
disposal decisions and measures of enforcement effectiveness. These
two elements determine where Inspections will be scheduled.
The steps in the scheduling technique are described below:
o Population
T) e base population of PCS equipment currently in service, by
industry, is defined. Such equipment includes transformers
and large capacitors.
o Dlsoosal Decisions
•The timing and location, by Industry, of rebuild/retrofit and
disposal decisions concerning the PCB equipment are forecasted.
This step is based on projections of the equipment installation
over time, equipment age, and the average length of service. The
result identifies possible target groups, and where and when an
enforcement presence is needed.
o Resource Allocation
Inspection resources are allocated among target groups in various
Industries. The allocation assigns inspection resources to target
groups where they ll1 be most effective in ensuring compliance
with the PCS regulations. Relative effectiveness measures are
based on a number of considerations including industry structure
characteristics, such as concentration and compliance likelihood;
costs of compliance; and level of awareness of the PCB requirements
by each sector.
The final product of the scheduling technique is a distribution of
Inspections throughout target groups within the economic sectors and
Industries which use the vast majority of PCB equipment. The technique
ensures that inspections are allocated In the most efficient possible
manner; that is, it maximizes the pounds of PCSs properly disposed of.
Within each target group, individual inspections will be performed at
plants and facilities that have been randomly selected.
-------
The Industries or sectors identified through the application oQthls technique,
and the percentage of Inspection resources allocated to each, are as follows:
o Ra11roads........... ......2O% a Paper and Lumber..............1O%
o Complaints, Crises, and a Commercial Buildings. ........ 8%
Special Situat1ons*..... l6% a Stone, Clay and Glass......... 5%
a Metals. , ... . . ..... . . .. .... .14% a Texti 1 es. .... . . . ... .. ......... 5%
a Chemicals..................l3% o Mlnirig........................ 3%
a Utilities..... ...... .......12% a Automobile.................... 1%
o Food and Feed..............lO%
* Approximately 16 percent of available Inspections are reserved for re ponse
to complaints, crises, or special situations which may tnvolve.conducting
Inspections or spot checks outside of the target groups. The determination
that a special Inspection effort is needed will be based on the potential
for human health or environmental hazard posed by the situation. If
required, appropriate downward or upward adjustments will be made to the
overall allocations to cover unanticipated greater or lesser numbers of
special situations.
Insoection Procedures
Inspections are Intended to detectmarking, storage, and use violations
while ensurlng.the accuracy of PCS records by verifying the existence
of and proper disposal of PCB equipment and liquids.
o General Inspection Activities
Inspectors will be alert for violations such as improper marking
and storage and for evidence of uncontrolled discharges from
leaks or spills. Possible violations will be documented by
taking physical samples, photographs, and/or other means as
necessary.
Inspectors will also collect data on the PCB equipment population 1 ,
including total number and type of equipment at the facility, the
stated quantities of PCBS in each, and other data as needed.
o Record Audits
In all Inspections, the Inspector will examine the facility’s PCB
records. Records of total PC8 quantities on site and their
disposition will be of primary interest. The inspector will
evaluate the records for compliance, for accuracy, and for
completeness. Any suspicious entries, or any missing entries,
will be explored further.
The Inspector will also make a comparative evaluation. When
historical records are available, they will be used in conjunction
with the present records to determine that a complete audit trail
exists for all PCB equipment.
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In addition, the Inspector will compare the facility record state—
ments on number and size of equipment against estimates that state
what is expected. These estimates are based on analysis which,
given any specific industry and plant configuration, can indicate
the number of PCB transformers and capacitors that can be expected
to be present. The inspector will match the recorded equipment
Inventory to the estimate; any significant deviation will be cause
for further Inquiry.
a Physical Inventory Audits
A certain pr porticn of the records will be verified by a physical
check. Using the inventory of PCB equipment shown In the records,
the Inspector will select and then physically inspect a certain
number of transformers and large capacitors.
5urmnary of PCa Penalty Policy
TSCA Civil Penalt ’ y tem
Section 16 of the T ic Substances Control Act authorizes the assessment
of administrative civil penalties against violators of the law and its
regulations. The law requires that in the determination of the penalty
amount, the Agency take lntb account the nature, circumstances, extent,
and gravity of the violation or violations. Other factors with regard
to the violator, su .h as ability to pay, history of prior such violations,
degree of culpability, are also to be considered. To implement this
statutory requirement, the Agency has adopted a ISCA Civil Penalty
System which establishes standard-fzad definitions and applications
of these factors. Specific penalty policies are developed under the
system for each TSCA regulation.
Under the system, penalties are determined in two stages: (1) Deter-
mination of a “gravity based penalty” (GEP), and (2) adjustments
to the gravity based penalty. In determining the gravity based penalty,
the following factors affecting a violation’s gravity are considered:
o The nature of the violation.
o The extent ” of environmental harm that could result from a
given violation, and
a- The circumstances ” of the violation.
Following is a sunmiary of the penalty policy develapd for the PC3
regulation. The full text of the TSCA Civil Penalty System and
the PCB penalty policy was published in the Federal Register
on September 10, 1980.
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PCE Penalty_Policy
The gravity based penalty, based on the nature, extent, and circumstances
of the violation, Is found on the following matrix:
Signi ficant
CIrcumstances
(ProbabIlity
of damages)
High
M d
range.....
range......
1
2
3
$25,000
20,000
1 ,000
$17,000
13,000
l0,0U0
$5,000
3,000
l , 0Q
4
10,000
6,000
1,000
Low
range......
5
6
5,000
2,000
3,000
l,300
500
200_
Following Is a brief discussion of how the extent and circumstances
categories are defined; the full text of the PCB penalty policy
should be consulted for a complete explanation.
o Extent
The extent is determined by th amount and concentration of the
PC3 material Involved. Weight is determined after concentration
reductions defined In the policy.
Major.......... 5000 kg. or more
SIgnificant.... 1000 kg. or more, but less than 5000 kg.
Mlnor.......... less than 1000 kg.
tf weight Is not available, alternative measures are
defined in the policy. They are based on numbers of
nunters of items, or size of area contaminated.
Any PCB disposal which results In contamination of surface or
ground water or food or feeds Is always major in extent.
o CIrcumstances
Circumstances are determined by the category of the violation;
the ranges are based on the probability of environmental harm
occurring from the violation.
Ilign Range
Level 1 Improper disposal
Manufacturing
Level 2 Processing
Distribution
Imorooer use
Me iurn Range
Level 3 Major storage violations
Major recordkeeping violations,
disposal facilities
Major marking violations
Level 4 Major recorakeeping violations,
use and storage facilities
A
Major
I - xtent or Potential Uamaqe
c
Minor
used as
gallons,
-------
Low Range
l
5
Failure to date PCB items placed
In storage
Minor storage violations
Minor marking violations
Level
5
Minor recordkeeping violations
Failure to use “No PCSs 1 ’ label
as
recuired
To determine the gravity based penalty for a violation 1 the extent
and circumstances are defined using the criteria described above,
and the appropriate amount found on the penalty matrix. After
the gravity based penalty has been determined, the adjustment factors
(culpability, history of such violations, ability to pay, ability
to continue in business, and such other matters as justice may
require) are considered and appropriate upward or downward adjustments
made.
Voluntary Compliance/Awareness Effort
A key objective of the PCB enforcement strategy Is to maximize voluntary
compliance; that is, to encourage that comllance be undertaken at a
plant or facility In the absence of any active enforcement effort there.
To accomplish this goal, It Is necessary for the regulated community
to be bosh aware of the PCB requirements and of the possible enforcement
consequences. of noncompliance.
An awareness effort will be undertaken aimed at encouraging compliance
In two kinds of circumstances:
o When noncompliance is due to ignorance of the regulations
themselves or their requirements, or
o When noncompliance is due to a low perceived risk of violation
discovery, and. subsequent punishment.
In addition, the awareness effort will encourage the adoption of good
stewardship practices to reduce the risk of uncontrolled discharge of PCBs.
The first part of the awareness effort will consist of ensuring that the
members of all industries which have high numbers of PC3 equipment are
aware of the regulations and compliance requirements. These efforts will
Include communication with company headquarters and plants, emphasizing
the following points:
o The health hazards of exposure to PCBs.
o The disposal, marking, and recordkeeping regulations.
o An Interpretation of the actions required by the regulations.
o A discussion of the sanctions available to the Agency’.
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The second part of the awareness effort directly supports the Inspection
pr’3gram and is aimed toward the target groups for which inspections have
been. randomly scheduled. The serious view which EPA places on PCB
violations will be publicized, with special emphasis on the Agency’s
vigilance and sanctions. Through this effort, members of a priority
target group will be given increased incentive to comply voluntarily
as they become aware that the risk of inspection is significant.
In addition to the two primary awareness activities, facilities will be
instructed in how to contact EPA when questions arise about the PCB
program, and they will be informed of EPA ’s *i1lingness to help
companies solve their disposal problems. PCE users will also be kept
informed of their legal disposal options. Some options, such as the
opening of new approved incinerators or storage facilities, may lower
the costs of compliance and thus. further voluntary compliance..
Particular attention in the awareness efforts will be given to those
industries whose private industry communication channels are not
extensive enough to spread Information to all Industry members and
to those whose current knowledge of PCBs as a hazardous substances
and of the PCB regulations is poor. The priority industries for
the first part of the continuing awareness effort include: textiles;
stone, clay, and glass; railroads; non—ferrous metals; food; and
conunercial buildings.
Special Programs
In addition to regularly scheduled inspections, specialized programs
will be required for two sectors——railroads and conm erciaI buildings.
o Railroads
PCB equipment used by railroads is coming out of service far
more quickly than in the other industries. As a result of
the innnediacy of the problem, all railroads with PCB equipmet t
will be Inspected to ensure that the equipment is being
disposed of properly.
o Can uercial Buildings
A significant proportion of PCB transformers are located in
conunerci.al buildings. However, the transformer population is
so dispersed through a multitude of buildings that building
Inspections are not an effective tool. A public awareness
program will be directed at building owners and maintenance
services, as well as to associations of such enterprises as
hospitals and schools, to inform them about the PCB requirements.
Other inspections will be scheduled In response to complaints, crises,
and special situations. The determination that a special inspection
effort Is needed will be based on the potential for environmental
harm posed by the situation. Special inspection efforts may involve
performing inspections outside the target groups identified in the
strategy.
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Allocation oi Responsibilities
Following Ic a sunmiary of the allocation of responsibilities between
the Pesticides and Toxic Substances Enforcement Division (PTSED) and
EPA Regional Offices.
PTSED
Regions
1. Inspection Scheduling
1. Inspection Scheduling
o The enforcement strategy Identi—
fies the economic sectors and.
Industries to be inspected and
allocates the percentage of
Inspection resources to be spent
on each on a national basis.
This will be further refined
to allocate the percentage of
inspections in each category by
Region, based on how the
number of Industry facilities are
distributed geographically.
2. Insoectlons
o Regions will develop a neutral
administrative Inspection scheme
for random selection of facilities
Ineach category in accordance
with the percentages assigned by
PT SED.
2. Inspections
o PTSED will lsáue a final PCB
Inspection Manual detailing
procedures for conducting PCS
inspections.
3. Case Develooment
o Regional personnel wll.i conduct
PCB Inspections in accordance with
the manual and the neutral admir 4 ctr
tive Inspection scheme.
a Regions will respond to complaints,
emergencies, and special situations
as needed.
3. Case Development
o PTSED will have lead responsibility
only in PCB cases of national
significance.”
o PTSED has issued a PCB penalty
policy and concurrence procedures
to be followed by Regions in
PCB cases.
o PTSED will provide policy
guidance and rule Interpretations
as needed.
4. Evaluation
a Regions will have lead responsibilit3
for all PCB cases except those “of
national significance.”
o Regions will seek concurrence for
PCB actions In accordance with
concurrence procedures.
4. Evaluation
o PTSED will review compliance rates
and other information to determine
the appropriateness of inspection
allocations and make adjustments
as needed.
o Regions will provide information n
violations found in each of th€
target groups.
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6EPA Enforcement Facts
and Strategy
Pblych IOn nated
B.i phenyls
(FOBs)
c o.
P
,t 41 v’
(/
Supporting Documents
-------
Enforcement Strategy
Polychiorinated Biphenyls
Supporting Documents
Contents
Page
Mote on Supporting Documents. .... . .......... .......• ... •. . ........ 1.
Allocation of Inspection Resources............................ 2
Table 1: Allocated Inspections by Sector or Industry........ a
Table 2: EstImated Number of Facilities by Company SIze..... 3
Inspection Scheduling...... .......... ...................... 4
‘TSCA/PCB Enforcement 5trategy ——Putnam, Hayes, & Bartlett.... 5
II Development of Target Groups.................................. 6
Exhibit 1: Target Groups for PCB Enforcement Strategy....... 12
ExhIbit. 2: Transformers In Service by Target Group.......... 13
ExhibIt 3: Capacitors In Service by Target Group............ 14
Exhibit 4: Average Number of Transforiners/Plant............. 15
Exhibit 5: Average Number of Capacitors/Plant............... 16
Exhibit 6: PCB Equipment Removed from Service by Sector....; 17
III The AwareneSs Component.... •1••• ..• .••,••. .. ..... . .. . ........ 18
Table 1: Industry Awareness of PC3s......................... 20
Table 2,: Industry Communication Channels.................... 22
IV The Inspection Component...................................... 24
ExhibIt 1: Theoretical vs. Real World Behavior............. 40
Exhibit 2: Adjusted Required Probabilities of Inspection.... 42.
ExhibIt 3: Inspection Efficiencies, Chemical Industry....... 43
Exhibit 4: Adjusted Required Inspections, Proper Disposal... 44
Exhibit 5: Recommended Inspection Schedule.................. 46
V Updati rig Procedures. . . ....... . .. ... ..... . . . . . . . . . .. .. . . . .. . .. . 49
Exhibit 1: InformatIon for Updating Enforcement Strategy.... 63
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Note on Supporting Docunents
The materials tn Sections 11-V are extracted from a report prepared
by Putnam, Hayes, and Bartlett under a contract with the Pesticides
and Toxic Substances Enforcement Division. They discuss the
methodology used in developing the statistical and analytical
foundation for directing the inspection and awareness efforts in
the PC3 enforcement strategy..
The final strategy reflects the findings of the contractor study,
with adjustiients made to reflect the practical experience already
gained by the Agency In implementing a PCZ enforcement program.
The materials are offered here only to demonstrate the theoretical
foundation of the strategy. Some of the report’s conclusions
have been rejected tn the fina’ strategy, and some matters
addressed In the strategy were outside the scope of the contractor
study.
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I. Allocation or Lnspection esources
Inspections of target groups have been scheduled based on both the
estimated quantities of PCBs coming up for a disposal decision and
the effectiveness of inspection activities in .that target group.
Inspections were allocated to target groups in such a way as to
maximize the total pounds of PCBs that receive proper disposal.
The method for determining the optimal Inspection allocation Is complex
and Is explained in detail in the supporting documents. The inspection
allocation is shown below In percentage of total Inspections for a
given year on a national basis. The number of actual Inspections will
be determined through the annual budgeting process. Because the
geographic distribution of facilities in the industry categories
varies, a further refinement of the percentages may be needed on a
Region—by-Region basis. This refinement will also take place during
the budget process..
Table lI—i
Allocated Inspections
(prr year, shown in percentage
by
of
Sector or Industry
uLdl number of inspections)
Percentage of
Sector/Industry Inspections
Rail roads... . . ..... . . ... . .. . . ............ 20 %
Complaints, Crises, Special Situations...... 16 S
Metals...... ....... ... . .. .......... ......... 14 S
Chemicals.. . ... ....... ...... ... . .... .. ...... 13 5
Utilities..... ..... ...... .. . ................ 12 S
Food and Feed............................... 10%
.11 1. 1t
raperafli.i .um.er............................
Connnercial Buildings........................ 8%
Stone, Clay, and Glass...................... 5%
Textiles.. ..... . .. .. . . .. . . .. . .... ... ... .. . ... 5 5
Minirig...................................... 3 5
Aut bi le....... . ..•... . ..... . . ...... ..... 1 5
Approximately 16 percent of the inspection resources has been reserved
for response to complaints, crises, and special situations. If there
is an unexpected higher or lower number of such sttuations, the
percentages may be adjusted evenly across categories. -
In addition, the inspections in each category should be performed
at facilities owned by companies of varying sizes. When possible,
approximately 50 percent of the inspections should be performed at
facilities owned by companies in the top 20 in size; 25 percent in
the next 30 in size; and 25 percent in the rema.ining companies. The
following table shows estimates of the numbers of facilities nationally,
arranged by size of company.
-2-
-------
Estimated Nunter of Facilities
Arranged by Size of Company
Sector/Industry
UTILITIES
Top 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
TOTAL
AUTOMOBILE
Top 4 Companies
Next 4 Companies
Remaining Companies
TOTAL
C IICALS
Top 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
TOTAL
FOOD
Top 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
TOTAL
METALS
Top 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
TOTAL
Facilities
360
216
446
571
943
2,536
58
11
163
495
258
3] .].
466
1,401
2,459
787
393
548
759
11 ,562
14,049
398
137
277
327
2,201
3,340
Sector/Industry
PAPER AND LUMBER
Top 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Compani es
TOTAL
STONE, CLAY, AND GLASS
Top 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
TOTAL
TEXTILES
Top 4 CompanIes
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
TOTAL
Facilities
452
316
509
588
9,436
11,301
366
169
237
316
1,404
236
149
249
419
2,054
3,107
MINING
Top 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
TOTAL
1,620
660
720
3,000
a e
6,000
-3—
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tnspection Scheduling
The neutral administrative Inspection scheme identifies the individual
sectors to be inspected, and targets a proportion of Inspections in
each sector to companies of varying sizes. Although facilities selected
for routine inspection should be part of a targeted segment, the Regions
may apply other neutral criteria, such as geographic considerations,
before making the random selections.
From time to time, a special, more Intensive inspection effort may
needed in a target or non—target group, such as in response to
new Information regarding potentially widespread contamination front
a particular source. In such cases, PTSED wil provide sufficient
Information to the Regions about the target group and any special
Instructions required so that the special Inspection program can be
Implemented.
The Agency also receives numerous tips and complaints regarding
possible PCB violations. The priority given to responding to
these situations is to be based on the severity of the environmental
hazard posed by the condition, to the extent that it can be determined
without on—site investigation. In some cases, an immediate inspection
will be indicated. The response to less severe problems range
from contacting the facility by telephone or correspondence to scheduling
of a compliance monitoring inspection as part of the Region’s routine
inspection plan.
When required, the percentages of resources allocated may be adjusted
evenly across the target groups to meet unanticipated Incre?ses or
decreases in the number of inspections needed for special situations.
—4 ...
-------
The materials on the following pages are extracted from:
ISCA/PCB ENFORCEMENT STRATEGY
Prepared by
Putnam, Hayes and Bartlett, tnc.
Bostcn, Massachusetts
December, 1979
Under a contract with
Pesticides and Toxic Substances Enforcement Division
Office of Enforcement
U.S. Environmental Protection Agency
-5—
-------
U Develo ent of Target CrouDs
The majority of the PCE’s currently in service arL
contained in transformers and large capacitors installed between
the years 1945 and 1975.1 while small quantities of PCB’s re in
service in other uses, the disposal of these PCB’s is not regu
lated due to their small quantities and/or low concentrations.
The enforcement strategy must, thérefore, concentrate on the
proper disosal of PCB’s intransformers and large capacitors. 2
In order to develop an enforcemen strategy that insures
the proper disposal of PCE’s contained in transformers and capaci-
tors, EPA must know where the transformers and capacitors are
located and when PCB’ a contained in the equipment will require a
disposal decision. Since EPA does not have detailed information
in these areas, .t was necessary to estimate where this equipment
is likely to be located and when it will be removed from service.
PEE has developed such projections for 47 target groups.
For the purposes of this analysis, a targe .group is
defined as a subsegment of industrial firms, utilities, railroads
or commercial buildings. Exhibit Il—i. iflustrates the target
groups used by Pan. As shown. th Exhibit 11—1, each industry in
the industrial sector and the utility sector is divided into five
target groups based on size of firm. The commercial and railroad
sectors are each treated as a single target group.
“After 1975, Monsanto, the primari’ manufacturer of PC3’s, ceased
production of these compounds.
2 Small capacitors may be disposed of as municipal solid waste and
hence, are not considered in the enforcement strategy. AL].
further reference to capacitors in this report refers to large
high and low voltage capacitors.
-------
The remainder of this chapter presents;
• PHB estimates of the number of PCB trams —
formers and capacitors by target group in
serv .ce in 1979,
• PEE estimates of the pounds of PCE’s re-
quiring disposal decisions each year by
sector, and
• the methodology used by PEE to derive these
estimates.
TRANSFORMERS AND CAPACITORS
BT TARGET GROUP
For each target group, -the number of PCB transformers
and, capacitors in service in 1979 is presented in Exhibits 11—2
and 11—3, respectively. As can be seen in these exhibits, 31
percent of all PCE transformers and 45 percent of all capacitors
in service in 1979 are owned by utilities. Other major users of
PCB equipment include the entire industrial sector and commercial
buildings. Within the industrial sector,. the majority of PCE
equipment is owned by the metals, chemicals, and paper and lumber
industries.
For some industries, the ownership of PCB equipment is
highly concentrated. For example, it is estimated .that 93 percent
of all of the PCB transformers and capacitors in the automobile
industry are owned by the four largest firms in the industry.
However, for some industries, such as food, a much. smaller portion
of the industry’s PC3 equi nent is conceiitrated in the four
largest firms..
Since EPA’s enforcement strategy must impact decisions
made at the plant level, it is also useful to project the number
of transformers and capacitors per plant in each target group.
4—
-------
These estimates are presented in Exhibits 11—4 and 11—5. As
illustrated in these frgures, the number of transformers per plant
ranges from 0.1 to 39.9 for the different target groups.l The
number of capacitors per plant ranges from 1.6 to 673.5.
REQUIRED DISPOSAL
DECISIONS BI .ZEAR
Exhibit 11—6 presents estimates of the number of poun.ds
of PCB’s requiring disposal decisions each year for each sector.
These projections were developed to determine if significant
differences in timing existed among sectors which might allow
enforcement activities to be concentrated in certain areas at
speific times. ,With the exception of railroads, however, signifi-
cant quantities of PCB’s are coining up for disposal decisions each
year for the next two decades. Thus, enforcement activities must.
begin immediately and must continue over the long term.
The PCB regulations essentially prohibit the use of
PCB’s in railroads after 1 January 1982. As illustrated in.
Exhibit 11—6, 3.6 million pc unds of PCB’s will be removed frozn
service over the 1979 to 1981 period. It is, therefore, necessary
to quickly implement enforcement activities in the railroad
sector. Resources so allocated, however, will be available for
other uses after 1981.
The pounds of PCB’ s requiring disposal decisions in
utilities and commercial buildings rises steadily from 1979 to a
peak of8 million pounds in 199 1 and 6.5 million pounds in 1990,
respectively. This suggests that, the EPA should plan a long term
enforcement program for the utility and commercial sectors.
1 As discussed below, the railroad and commercial building sectors
present unique enforcement problems. For this reason, thes&
sectors are excluded from this plant—specific analysis.
-------
However, there are still significant amounts of PCB’s being
released prior to the peak, and hence, the start of- the enforce—
inent program- should not be delayed. -
The industrial sector poses the most immediate threat of
improper disposal of PCB’s. It is, therefore, crucial to promptly
Implement the enforcement strategy for the industrial target
groups.
!4ETHODOLOGT FOR DERIVING
ESTIMATES B TARGET GROUPS
There cur rently exist no. records of PCB transformer and
capacitor in tallatioris by target group. It was therefore neces-
sary to estimate for each target roup the number of transformers
and capacitors installed each year, the number of transformers and
capacitor ’s which were still in service at the end of 1979 and,
finally, when each of these- transformers and capacitors would be
removed fre. service. The methodology for doing this s described
briefly below. 1 -
Transformers are used to step up or step down the
voltage level of a current of electricity. Capacitors are used to
regulate the flow of electric current. Since both transformers
and capacitors are used to conduct or regt.alate the flow of
electricity, it was assumed that the installation of transformers
and capacitors within each sector and industry would be propo —
tiorial to that sector or industry’s use of electricity. hus,
estimates of total existing PCB transformers and capacitors from
previous work by -Versar, Inc., were allocated to sectors and
industries based on electricity use.
more detailed discussion is presented in Appendix A.
-------
Once the total existing PCB capacitor and transforme
installations were determined for each industry, the number ot
installations each year over the period from 1945 to 1975 was
determined. These years were selected since they represent the
period in which PCB—containing equipnent was manufactured and
sold. The number of installations in each year of this period was
estimated, using. the pattern of the sector or industry s capital
expenditures.. A computer simulation program then was used to
project the year in which the equipment would be removed from
service given the initial installatiofl date,.an average failure
rate and an average lifetime. 1 Mote that no specific adjus ent
was made for possible early removal motivated by EPA regulations
or other factors.
Due to the large number of firms within each industry
and the diversity of firm sizes, P33 next allocated the number of
PCB transformers and capaèitors existing in 1979 t target grcupr
within each industry. To define the target groups of interes
within each industry, two steps were taken: 2
1. Subsegments of the industry which represent
the ten 1ar est users 3 of electricity within
each industry were selected.
1 1n the case of transformers, the lifetime may be extended by
several years by rebuilding the transformer at the end of its
initial service life. If the transformer was rebuilt prior to
1975, it was assumed that the PCB fluid was replaced in kind.
After 1975, it was assumed that the replacement fluid did not
contain PCB’s. If the transformer is rebuilt, the PCB’s initially
in the transformer are removed from service at that tiin .
2 See Appendix A for a more detailed explanation of this procedure.
3 Users are defined here by four—digit Standard Industrial Classi-
fication code (SIC).
-------
2. The plants within these ten largest elec—
trinity users were divided into the five
target groups defined in Exhibit 11—1.
It was assumed that the subsegments selected within the industry
would have all of the PCB transformers and capacitors within that
industry. Further, across the five target groups the number of
PCB transformers and capacitors was assumed to be proportional to
output.l For example, if the four largest firms (the first target
group) accounted for twenty percent of the output of all five
target groups, twenty percent of the FCB transformers and capaci—
tors are assumed to be in. plants owned by these four firms.
The. utility sector was also divided into five target
groups in the manner described above, while the commercial and
railroad sectors were each defined as a single target group. The
time. pattern of PCB disposal decisions was assumed to be the same
for each targetgroup within an industry or sector.
1 Dollar value of shipments is a widely accepted measure of output
and was used for each target group.
— 1 1
-------
TARGET GROUPS FOR TSCA/I?C13 ENFORCEMENT STR4TEGY
SECTOR INDUSTRY TARGET GROUP
Food 2. Next four companies within an industry.
I INDUSTRIAL J > Mining 3, Next twelve companie within an industry.
Stone 1 Clay and Glass 1, Four largest companies within an industry,
____________ Textiles 4, Next thirty companies within an industry.
Paper and Lumber 5, RemainIng companies within an industry.
Me tale
Chain Ic ale
Automobiles
1. Four largest utilities within an industry.
2, Next four util$ti within an industry,
LITI
3, Next twelve utilities within an industry.
4. Next thirty utilities within an industry.
5, Remaining utjlitIes within an Industry.
COMMERCIAL 1 I COMMERCIAL
BUILDINGS I >1 BUILDINGS
RAILROADS 1 - RAILROADS
-------
11 5E YI Z 1 — 3.979.
8.1.90 TOp 4 Fi
2.144 Next 4 Fi
2.487 Next 12 Ft
1,537 Next 30 FL s
1. 3 JILL - iniri3 Fi
5.755 Top 4 Fi
2,335 Next 4 lix
3,199 Next 12 fi
2.308 Next 30 I’t
949 ALl. p.. f ii i
2.1.54 Top 4 Pi
1,043 Next 4 !ie
Next 12 Ft
1.325 Next 30 FL
1.740 ALL aini ti
743 Top 4 Fi
305 Next 4 FLs
333 Next 12 fL
1.335 flext 3U F1
0 A.L3. ti
2,312 TOp4 t1
124 Next 4 Fi
12 Next 12 fi
12 Next 30 Ft
25 ALl. ii iri 5 ‘j
777 Top 4•i j
435 Next 4 Eic e
502 Next 12 Fi
499 Next 30 L
1.3.34 ALl. iru. T1
624 Top 4 !i
259 Next 4 E ix
43.8 text 12 Fi
398 Next 30 F1
342 ALl. frit
1.260 TOp 4 3i3
36 Next 4 Fi
417 Next 12 Fi s
220 Next 30 Fi
147 ALl. 1x
5,513 Top 4 F1
3,200 Next 4 fL
6,334 Next 12 Ft
— 8,736 Next 30 L
— .4,444 ALl. ? .“ “ r Ls
34,015 ALL 3uildi o
[
eAlE&
7,840
2,771
2. 48S
3.247
I
$25 All. Pailco. ds wLt!
Equ .i ent
-------
&_ _&Ia . £. .—J
D l f — 1979
(th aza s aL utu.tz)
225 I’0p4?te
36 Next 4 F
38 Next 12 Ft
23 Next 30 F1s
19 ALl. P 4 ” 4 ’q Fi
9L 1 p4 Fi
38 tlext4 Fi
51 Next Ft3
37 Next 30 Ei
15 ALL pi ain(r Fis
34 ttp4?i
16 Next 4 Ft
25 Next12Fi
21. Next 30 Fi
28 ALl. Fi
15 4 Fi
6 Next4F1
7 $extlZFis
29 Next 30 £i us
0 ALl. 3 kiir Fi
39 L’bp4Ti e
2 Next4Fir s
0 2 Next 12 F1s
0.2 Next 30 Fi.
0.4 ALl. Pm ur.g Ft
13 1 p4tie
7 Next 4 Fthxx
8 Next 12 E1
S Next 30 tic s
19 ALl. P a.in. Fi
10 p4Fi
4 Next 4 ii
7 Next L I Fi
6 Next 30 Fi
6 ALl. .inia ?j
21. t 4 Yi
6 Next 4 Ft
7 Next. 12 Ft
4 Next 30 fj
3 ALl. aixti g FLs
190 L p4FLx
114 Next 4 Firrns
236 Next 12 E1
301 Next 30 F1r
495 ALL exa iw Fi e
779 A.U 3uildth s
a
124
c7
5 !
r I
I
F
0 11.1. ai1oad vith
-------
AVEPGZ NL1’ IS C?
— 1979
20.6 ‘Ltp 4 Fi
1.7.1. Next 4 E’
9.0 Next 12 F1
4.7 Next 30 Fi
0.6 AU. m* n g ‘i
11.6 p 4 ?t
9.3 Next 4 E’i
10.3 &ext .2 ?1.
5.0 Next 30 11.
0.7 AU.
4.8 L 4 Fi
3.3 Next 4 E 1 i
3.1. Next 1.2 Fis
L I Next 30 Zis
0.2 ALl. Pe ein.ir g ta
0.5 bp 4 fte
0.5 Next 4 Fis
0.5 Next 12 Fi
0.5 Next 30 Fi
0 ALl a.ithtg ?ie
39.9 !tp 4 Fi
11.3 Next 4 Fi.e
0.7 Next 12F Le
_____________ 0.4 Next 30 FLe
0.2 ALL aia Fis
_________ 1.3 t 4 ie
1.1. Next 4 Fi.e
0.9 Next 12 Ft
______________ 0.7 Next 30 Fi
0.1. ALl. ai.ni.ig Fiz
2.5 ‘Lb 4 i
j . .g Next 4 Ftr s
1.7 Next 12. F1e
1.0 Next 30 £i
0.1 . AU. *ti .th g Ei
Itp 4 F1
Next 4 F1
Next 12 Yts
Next 30 ?1e
All. eai.ning Fis
1 4 FL=e
Next 4 Fiz
Next 12 F1s
Next 30 Fis
All
Note: zfoero pee site for ercial buildi. s
and raj..Leoeds flave s t seen est aeed.
1 Tran foers er plant y tagget group i3 c putad by
dividing the data in ithit 1.2-2 by the m.oer o
plantz i.x e t 5et group. See , çeedix A for a
detailed dis asicn. -
1=
3.4
2.2
1.8
0.7
0 1.
15.3
13.3
1.5.3
15.1
15.3
—1
-------
?IVERPGE NU 3 CF CPA VRS/PLL r 1
3! JP - 1979
1 Caac1t rz LaAt ty target gcip ia c utad y
divi i the data ii Exhibit 11—3 y the o
plants in e target gr ip. $ e er dix A for a
detaiLed di s- on. -
314.1
252.8
127.2
70.3
8.5
147.3
1 .54.0
79.4
10.8
75.2
50.6
49.1 .
35.7
2.9
9.5
9.5
9.5
9.5
U
191.9
12.4
7.0
3.’
15.2
13.2
19.1.
10.3
1.5
42.5
29.0
27.0
1 .5.3
2.7
53.5
37.3.
29.9
11.3
L3
528.2
523.2
523.2
523 • 2
523.2
1 p 4 E’is
Next 4 F
Next 12 F1s
Nest 30 E1
ALL 3e aining Eis
ltp 4 Ets
Next 4 Fi
Next 1.2 Fi=
Next 30 E1s
ALL !i=3
Next 4 F1
Next 12 Fis
Next 30 Fis
ALL aini Fi
T p 4 Fis
Next 4 E’i
Next 12
Next 30 FL
ALL nin .ing Ei
L 4 F1s
axt 4 Fi
Next 12 F1=.x
Next 30 F1=s
ALl. 3 ain .thq iis
p 4 F1s
Next 4 Ficee
Next 12 F1s
Next 30 FL=3
ALI . aiAing Fie
cp 4 Fis
Next 4 F1=e
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iaxt 30 Fis
ALL . ain.u g F1
p 4 F1
Next 4 FLx.
Next 1.2 Ft
Next 20 Fie
ALL “ i g F1=s
4 Fi
Next 4 Firms
ext 12 fIrms
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ALl. ai .rurq Firms
iU . iW .i
—
C
F
Note; ansfn 5eU FSt Site for cn rciaL i1di. s
azx cail a z have ot been esti ated.
— 1 6.
-------
15c.00000 +
PCB’S REMOVEP FROM SERVICE
1979 2005
TRANS FORMEBS AND CAPACITORS BY SECTOR
-+-+—+--±+—+-.+.-+ +-.
.13 00O00 +
12000000 +
10500000 4
00Q90
‘sooqoo
.4000000
4500000
3 000C)0()
! 500000
0
+
p
+
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A Rai7 road 1 ,
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111 1.111 11111.1111 11111222222
99999999990099 99 9 99000C)00
7 8 9 B fl S 9 9 c 9 . 9 9 9 0 0 0 C) () 0
0 2 3 4 5 7 9 0 1 2 4 7 8 9 0 1. 2 $ 5
FCU P TTH’4t Y fR0LS
— rPir! TR’p ,
‘U’ —- IJTJL1TY P ’S
—— rr f i F’r fl’ 3
•‘r -.. r?r’ fl VF
—.1
S.
p
p
p
C , ,nercial
S
S
-------
III The Awareness Comoonent -
The objective of the awareness component of the PCB
enforcement strategy is to maximize voluntary compliance; that is,
to encourage compliance at a plant or facility in the absence of
any direct enforcement effort there.
Awareness efforts aimed at individuals who will make PCB
disposal decisions are one of the major enforcement tools avail-
able to EPA. Althou h such efforts can b very inexpensive on a
per plant or per firm basis, their ef fectiveness is likely to be
limited unless the suspected cause of noncompliance is lack of
knowledge about the TSCA/PCB regulations, the sanctions available
to EPA, or the Agency’s enforcement efforts. Thus, to maximize
the dverall ef e’tiveness of EPA’s PCB enforcement efforts, re-
sources should : spent on awareness efforts which arq aimed at
target groups, industries or sectors where these problems arise.
There are two parts to the reco drnended awareness corn
ponent — the distribution of PC3 information and inspection
support. Each of these parts is described below. These awareness
activities should be considered as continuing efforts by the
Agency.
DISTRIBUTION OF PCB INFORMATION
The first part of the awareness component attempts to
increase knowledge of the PCB regulations, disposal options, and
enforcement efforts among those industries that have a large
amount of PCB equipment. There are two levels to this effort.
The initial leve1 of the effort will be directed toward
industries where current levels of awareness are low. These
industries must be informed, through •communicatiorz with company
headquarters and/or plants, of the following issues:
—l
-------
• The health hazards of exposure to PCB’s,
• The disposal, marking and recordkeeping
regulations,
• An interpretation of what actions are
required by the regulations, and
A discussion. of the sanctions available to
the Agency in the event of noncompliance.
Facilities should also be instructed on how to contact EPPJ when
questions arise about the PC3 progra.
Selection of the industries which will be the principaL
beneficiaries of this part of th& awareness component is. based on
several measures of current knowledge. The information needed to
rank the industries was provided in most cases by inb rviews with
industry representatives.
The interview responses show •that certain industries
have far better information about PCB’s than do others, as indi-
cated in the table below. There are three ba ic levels of aware-
ness upon which industries were ranked. First is a basic
knowledge of PCB’s as a hazardous chemical substance; second is
knowledge of the PCB regulations and the compliance requirements;
and third is awareness of the possible costs of compliance on the
industry.
-19—
-------
TABLE 111—1
INDUSTRT AWARENESS OF PCB’ S
AWARENESS
PCB’S A
NO EAZARDO S PCB COST OF
IND JSTRY AWARENESS CEEMICAL REGULATIONS COMPLIANCE
ti1ities
Textiles
Paper
Stone, Clay & Glass
Steel -
Non—Ferrous- Metals
Railroads
Food
Automobiles
Commercial Buildings .
Chemicals
Mining
Those industries that already know about the nature of
PCB’s and about the regulations are as aware as the first level of
the PCB awareness program could niake the n. The resources dedi-
cated to this level should therefore concentrate on the industries
or sectors which appear to be relatively ignorant of their com-
pliance requir nents. These industries, based on the table above,
are:
—2;
-------
• Teztiles
• Stoner Clay and Glass
• Non—Ferrous Metals
• Railroads
• Food
• Commercial Buildings
The second. level of effort is the provision of updated
information about PCB t s and PCB issues. Such information should
b distributed,, possibly through large audience publicity tech-
niques, to all PCB user industries. PC3 users should also be kept
informed of their legal disposal options. Some. options, such as
the opening of new approved incinerators or storage facilities,
may lower the costs of compliance and thus further. encourage
voluntary compliance.
SPECTICN SDPPOB
The second part of the’ overall awareness component
directs information specifically toward the target groups re-
ceiving inspection activity. The success’ of the inspection
component relies strongly on the assumption that decision ‘makers
in target groups will make the choice for proper disposal only if
they are aware of their- likelihood of inspection, their costs of
compliance and the likely fine should a violation be detected.
Providing and updating this information is therefore an important
part of the awareness effort.
The Agency can rely on private channels of communication
to distribute important” information (such as PC3 compliance costs)
to target group members of more organized industries. aowever,
2 1—
-------
special efforts should be undertaken for the target groups within
those, industries when communication among !nembers is limited.
The information used. to determine which industries are
1ikal y to have poor communication, and where, therefore, special.
e ort is required, was taken from, interviews with industry
representatives. Industry associations were questioned about the
ex istence of regular and frequent channels of communication (f5
example, industry newsletter) and whether environmental committees
existed and distributed environmental informa ion. The results
are shown below.
TABLE 111—2
INDUSTRY COMMUNICATION CHANNELS
LITTLE ENVIRON-
COMMUNI— NEWS— OTHER MENTAL
INDUSTRY CATION LETTERS CHANNELS COMMITTEES
Utilities
Textiles
Paper o
Stone, Clay & Glass
Non—Ferrous Metals
Railroads
Food*
Automobiles
Commercial Duildings* •
Chemicals
Mining
Steel
* Est imatel.
—2 2
-------
Target groups in industries which have at least one form
of regular and/or frequent communication and in addition have a
formal committee which keeps members alert to environmental issues
are likely to learn of PCB developments on their own. However,
target groups in industries without such organization may not.
hese industries, whose target groups wifl need extra awareness
e focts, are:
• Textiles
• Stone, Clay and Glass
• Non—E 1 errous Metals
• Railroads
• Food
• Commercial Builóings
, q —
-, .1
-------
I V The Inspection Com nnenc
The objective of the inspection component of the
TSCA/PCB enforcement strategy is to provide a direct pliysica.1.
presence at a sufficient number of plants and facilities where PCB
disposal decisions are made to insure compliance with the regula-
tions. The impact of a single inspection is not Limited to the
site inspected. Bather, it combines with all other inspections to
build a perceived risk of discovery and resulting sanction that is
sufficient to encourage decision makers faced with PCB disposal
decisions to favor compliance over noncompliance.
Inspections are one of a variety of enforcement tools
available to EPA. Research by PUB indicated that inspection
activities have been found to be effective by a number of regula-
tory agencies. In particular, the TJ.S. Food and Drug Adzainistra—
tion (FDA) has carried out research concerning the relati
effectivenes.s of a variety of inspection rograms.l This research
indicated several important considerations for the development of
the TSCA/PCB inspection component:
1. Inspections based solely on complaints were
found to be a poor use of the FDA’s re-
sources.
2. Inspections which were followed up by a
letter to the company’s headquarters (not the
site inspected) summarizing the results of
the inspection, the required action, and the
possible sanctions for continued noncompli-
ance were particularly effective.
1 See Appendix B for further information on the FDA results.
— 24—
-------
3. Inspections which .concluded with the issue of
a formal citation actuaLly hindered quick
remedy of the violation.
As described in tapter I, the overall goal of the.
TSCA/PCB enforcement strategy is to minimize the amount of PCB S
released to the environment through minimizing disposal viola—
.tions.. Other technical violations of. the regulations , although-
important, are not as critical, as illegal disposal. t is diffi—
cult, however, to implement inspection activities so as to detect
disposal violations directly. To solve this diLfjCUltyr the
inspection component as well, as the en tire enforcement strategy
depends upon PCB records as an acceptable indicator and motivator
of compliance. Maintenance of a curate records by a plant or
facility provides a measure of overall compliance as well as an
indicator and’ audit trail for specific violations. The ractiaal
intent of the inspection component, therefore, is to fostec and
verify the creation and maintenance of complete and accurate PCB
records.
The inspection component will focus on three categories
of sectors and industries which require different approaches to
inspection. Each of these approaches, however, seeks to maximize
inspection effectiveness by allocating inspections to target
groups where the inspection will be most effective in causing
PCB’s to be disposed of properly. The first category includes
all. utility and industrial users of PC transformers and
capacitors. The second is made up of commercial buildings that
use PCS equipment. Railroads that use PC3 transformer-equipped
locomotives comprise the third category. In addition, some
inspection resources will be allocated to complaint response and
emergency situations. The remainder of this chapter presents the
recommended inspection activity in each of these areas.
-------
UTILIT! AND I1 DUSTRIAL USEBS
Utility and industrial users contain the largest numbers
of PCB transformers and capacitors, and inspection activity in
target groups in these two sectors is found to be relatively
effective. The material below describes the activities carried
oit an an inspection and the scheduling of inspections to specific
target groups.
•Inspection Activities
Most ins cions will be audit inspections in which
records of PC3 equi nent are sampled and verified. There are two
types of : basic audit inspection, which are distinguish d from
each other by the kind of PCB equipnent of primary interest. In
the first type, the inspector will audit all records but will
verify transformer records only. In the second, the inspectic
will verify both transformer and capacitor records. This type
termed a “joint” inspection. In both types of inspections, all
records will be examined by the inspector. The fundamental
difference in inspection types lies in which records will be
physically verified.
A distinction was made between these two types due to
their cost differential, which becomes. important when inspection
resources are distributed to achieve maximum effectiveness.
Ai.though the exact costs of the t types is not currently known,
it is clear that a joint inspection, which requires more time,
must be more expensive. Thus, it was assumed that a joint
inspection costs 50 percent more than a transformer inspection.
—26
-------
In both types of inspection, similar activities must be
performed. An audit of the records kept for each piece of PCB
equipment must be performed, and in addition, a certain proportion
of the entries will be verified by a physical check. Both of
these procedures are described in more detail below.
Record Audits
In all inspections the inspector is required to examine
the plant’ a PCB records.. The inspector shall evaluate the records
for compliance, for accuracy, and for completeness. Any suspi—
cious entries, or any missing entries, will be investigated.
The inspector will also make a comparative evaluation.
When historical records are available, they must be used in con-
junction with the present records to determine that a complete
audit trail exist for all PCB equi xaent.
In addition, the inspector should compare the plant
records of the number and size of PCB equipment owned against
standards for a representative plant. These stafldards should be
developed by EPA based on analysis which, given any specific
industry and plant configuration, can indicate the nw ber of ?C2
transformers and large capacitors that should be present. The
inspector will match the recorded equipment inventory to the
expected; significant deviations from the standards will be
investigated.
Physical Inventory Audits
A certain proportion of the records will be verified by
a physical check for PCB equipment. Using the inventory of PCB
-2 7_
-------
equipment shown in the records, the inspector shal2. physical
inspect a representative sample of transformers and/or large
capacitors. The inspector should verify the presence of the equip-
ment and, in some cases, the PCB content of the equipment (through
chemical analysis). The proportions to be so checked should be
statistically detErmined to achieve a minimum level of confidence
regarding the overall accuracy of the records.
Inspection Scheduling
The goal of the inspection scheduling method is to
alloc.ate limited inspection resources to specific target groups so•
as to cause the proper disposal of the largest possible quantity
of PCB’s. This requires ‘!t inspections be allocated .to the
target groups in which they will be most effective. Estimating
the effectiveness of an inspection requires an analysis of the
compliance decision and the factors that influence it. Tb’
compliance decision is made by PC3 equipment owners based on
variety of economic and noneconomic factors. PEB has considered
both of these types of factors in calculating an inspection
efficiency for each target group. The inspection efficiencies are
used to develop a schedule c recommended inspections per year by.
target group. The steps in the determination of the inspection
efficiencies and the scheduling of inspections, and a brief
description of each, are presented below.
Step 1: Consideration of
Economic Factors
The compliance decision based on economic factors is
considered as a choice between the cost of compliance and the
economic risk of noncompliance. The economic risk of noncom-
pliance is a function of the perceived probability of inspection,
—
-------
the duration of the inspec iori effort, arid the inagnitude of thE
likely penalty if a violation is detected. l The perceived proba-
bi.lity of inspection must be large enough, given the duration o
the effor.t and the likely fine, to induce decision makers to
select compliance based on economic factors. The probability of
inspection, given estimates of duration and penalty, required to
insure the proper disposal of a target group’s PCB’s can be
calculated. The number of inspections required to achieve this
probability is the required number of inspections to achieve full
compliance based on economic factors.
Step 2: Consideration of
Noneconomic E’actors
Noneconomic factors affect the decision maker’s likeli-
hood of compliance Irrespective of economic considerations. Such
noneconomic factors include the decision maker’s level of aware-
ness of the regulations and of the. PCB problem as a whole, the
quality of communications channels available to the decision maker
which effect the availability of information required to make
informed decisions and .the decision maker’s attitudes toward cont—
pliance as reflected in his historical behavior when confronted
with environmental regulations. These factors are assessed and
combined to determine a relative likelihood of compliance for each
sector and industry based on noneconomic factors. This relative
likelihood is then used to adjust the required numbers of Inspec-
tions for each target group to arrive at inspection requirements
that reflect.both economic and noneconomic factors.
1 For the purposes of this analysis, PEB has assumed that viola-
tions are always detected if an inspection if performed at a
noncomplying facility.
-------
Step 3: ScheduLing Inspect ions
Dividing the target group’s quantity. of PCB’s by the
adjusted number of inspections required yields an inspection
efficiencyu for that target group. The inspection efficiencies
are. used in a computer model which allocates a fixed quantity of
..in pection resources to target groups in a manner which maximizes
the quantity of PCB’s properly disposed.
iese steps in. the inspection scheduling method for
ut-ilities and other industrial users are descr.thed in more detail
below.
STEP 1: CONSIDERATION OF
ECONOMIC FACTORS
The compliance decision is made after the consideration
by the decision maker of the economic and noneconomic ramificr
tions of all options involving compliance and noncompliance.. T .
economic factors cause the decision maker to view the compliance
decision as an economic choice between the cost of compliance and
the economic risk of noncompliance. The economically rational
decision maker will comply with the law only when his cost of
compliance is less than the economic risk of noncompliance.
The cost of compliance is the sum of the various costs
associated with the proper disposal of PCB equipment. These costs
may include the cost of retrofilling a transformer to lower its
PCB content, the cost of incinerating or otherwise disposing of,
or storing PCB fluids, the implicit, cost of prematurely disposing
of PCB equipment, and other related costs. The cost of compliance
may also vary among seve.ral compliance options, al). of which are
within the law.
-------
The economic risk of noncompliance depends upon the ris
of being inspected in any given year, and the dollar value of thi
fine imposed if caught. For example, if there is a one—yeai
inspection program in which there is a 10 percent chance of beinç
inspected and the fine if caught is $50,000, the economic risk (oz
the expected cost of noncompliance) is $5,000. EPA’s inspectior
effort will continue, however, into the foreseeable future ir
order to insure the proper disposal of PC3’ s that wili be removed
from service in the next ten to twenty years. In a multi—year
inspection effort there is a risk of inspection and discovery in
each. year of inspection activity. This makes the total economic
risk of noncompliance considerably greater and allows the proba-
bility of inspection in each year of the program to be lower than
would have been reqi.iired to create the same perceived risk in a
single year.
In carrying out this step, PHD has assumed that
inspection activity aimed at enforcing the TSCA/PCB regulations
will continue for at least ten years. If inspection activity is
reduced or ended earlier than this, the required probabilities of
inspection calculated by PEB are too low to insure compliance. In
addition, PEB has assumed an average penalty of $50,000 for each
transformer or capacitor disposal violation discovered. 1
Although the calculations required to compute the proba-
bility of inspection needed to equalize compliance and noncom-
pliance costs are essentially the same for transformers and capaci—
1 Analysis of the likely disposal violations indicate that if 2000
pounds of PCB’s are disposed of illegally (equivalent to one PCB
transformer or 43 capacitors), a $25,000 disposal. fine and a
$20,000 marking violation fine are likely to be imposed. It is
further assumed that a $10,000 recordkeeping violation fine will
be imposed in half of the cases. This results in a $45,000 to
$55,000 average fine with a median value of $50,000.
:
-------
required to insure that the decision to comply with be econr
ally preferable for each target group calculated. In r z. li
however, the decision is also influenced by noneconomic factorE
which are unaffected by the economic circumstances. The derivatior
of the required probability of inspection assumes that the corn-
pliance decision is ‘made on. the basis of economic factors anc
perfect information. This means that no decision make: in
target group wiLl. comply until the probability of inspection makeE
the expected cost of noricomp].iance higher than the host of com-
pliance. As soon as the cost of noncompliance is higher, however,
all decision makers in a target gróup will” immediately choose tc
comply. This behavior is. represented graphically in Figure A oI
Exhibit IV—l.
1n reality, of course, the costs of compliance anc
noncompliance are uncertain. The quality of the information and
the ability to interpret it will, vary between individuals.
owners will be better able to judge the 4 tzu&’ ec nomic and re ,. i—’
tory situation than others. These considerations lead one to ex-’
pect a somewhat smooth shift toward compliance as the probability
of inspection increases. This behavior is represented in Figure E
of Exhibit Ill-i .. In Figure C of Exhthit V /—i, a straight-line
approximation of -this shift is diagram ned. Such an approxiutatior.
was assumed to simplify later computations.
In order to adjust the required probability of inspec-
tion to approximate t smooth Shift behavior explained above, the
probabilities were increased by a percentage proportional to the
ambiguity of the compliance decision and the likelihood of a
decision error. The adjusted probability represents the proba-
bility of inspection at which all decision makers in a target
group choose to comply given the smooth linear shift described
above. This is illustrated in Figure C of Exhibit IV— ] .. The ‘d-
-------
justed required probabilities, of inspection by target group are
presented in £xhibit IV—2.
The number of inspections required to achieve the
required probability of inspection can be calculated using thi
number of plants and pieces of PCB equipment in each target group.
T] e method of •computation differs slightly for transformers and
capacitors due to the assumption that a separate compliance
decision is made for• each transformer while capacitors are the
subject of a single, plant—wide compliance decision. An example
computation for the chemical industry appears in Exhibit IV—3.
•For a full, discussion of the methodology for calculating the
required numbers of inspections, see Appendix C.
There are, however, other noneconomic factor which
affect the compliance decision. These noneconomic factors combine
to determine a relative likelihood of compliance for each sector
and industry which is used. to adjust the required number of
inspections determined on an econQrnic basis.
These noneconomic factors- and their effect on the
likelihood of compliance are listed below:
• Quality of Information Flow. Inasmuch as
rapid and accurate information flow is
crucial to the accurate perception of the
options and risks facing the decision maker,
industries with well—developed communication
channels (such as those created by industry
associations) are more likely to understand
their choices and make economically rational
decisions..
• Degree of Industry Concentration. Concen—
trateci industries are able to communicate
information mare effectively. Decisions in
concentrated industries also effect greater
quantities of PCE’s, thus making widespread
compliance easier to achieve.
— 34.
-------
• Level of Awareness of P c ! Regulations. In—
dustries already aware of the PCB regulations
are more likely to comply inasmuch as non-
compliance due to ignorance is less likely.
• Compliance flistory. Industries with a his-
tory of noncompliance and resistance to
environmental regulations can be expected to
resist complying with PCB regulations.
Each of these factors is considered in. a comparativE
ranking technique used to quantify each sector and industry’s
resistance to compliance based on n.oneó nomic. factors. The
results of the comparative ranking are used to adjust the required
number of inspections to achieve full compliance for each target
;r’nip by as much as a twenty percent increase or decrease. If thE
likelihood of compliance is high for an industry, - the required
number of Inspections for the industry’s target group is reducec
by as mudh as twenty percent to allow for a higher ex c
ef ctjveness for an. inspection in that industry. The adjLec
number of inspections required to insure that all of a target
group’s PCB’S are properly disposed is presented in Exhibit IV—
for each target group. Appendix Dcontains a complete discussior
of the calculation of the adjusted required number of inspections.
S E ’ 3: SCDEDULI G INSPECTIONS
The adjusted number of inspections required for uU
compliance are used to calculate inspection efficiencies which car
then be used to schedule inspection resources in the most effec-
tive manner.
Inspection efficiencies are computed by dividing tht
pounds of PCB’s properly disposed (assumed to be 100 percent o
the target group’s transformer and capacitor PCB’s) by the r i
of inspections needed to raise the probability of inspccti . tc
-------
the required level for a given target group. This computation
asstmtes that the increase in PCB’s properly disposed for each
additional inspection is constant.’ Although inspection
efficiency may be expected to diminish as the amount of properly
disposed PCB’S approaches 100 percent, this approximation .is
considered to be sufficiently accurate for the purpose of
aflocating inspections comparatively among target groups. Exhibit.
17—3 provides an example of these. calculations for. target groups
in the chemicals industry.
After computing the inspection efficiencies as described
above, the efficiencies can be used to allocate inspection
resources to, target groups in the most efficient manner in order
to maximize the pounds of properly disposed PCB’S. To accomplish
this task, a cànipuj r model was prepared that allocatesa limited
nt nber of inspection resources to specific target groups. The
model finds the allocation of inspections that results in the
maximum quantity of properly dis osed PCB’s througfi use of linear
programming, an analytic technique useful, for calculating the
optimal use of limited resources. The program allocates inspec-
tions to target groups with the highest inspection efficiencies
until available inspection resources are exhausted. Some target
groups with low inspection efficiencies thus are not inspected. A
complete discussion of the model and its operation is included in
Appendix E.
The output of the model is a schedule of the number of
inspections that should be allocated to each target group each
year. As described previously, irrspections have been divided into
two types. The first concerns itself with transformer records
1 This could be described graphically by a straight line drawn from
the origin to the point on the smoothed curve above the adjusted
risk of inspection as in Figure C, Exhibit 1V1.
-------
only at a given site, and the second examines both transforme
capacitor records. The model stipulates the use of a joint ir.
tion only when the added cost of the inspection of capacitors as:
well as transformers at a given site results in a larger quantity
of properly disposed PCB’s than if the additional resources were
expended elsewhere. l
The results of the computer model are shown in Exhibit
IV—5. Four hundred of the five hundred available inspections were
aLlocated to utility and industziàl target groups. 2 One hundred
inspections were reserved for commercial building and railroad
target groups and emergencies.
COZ4NERCIAL BUILDINGS
Commercial buildings, generally offices or public
buildings, can contain PCB transformers and capacitors used
general electricity requirements. These buildings are scattL ...d
throughout the U.S. and the concentration of PCB equipment in any
target group of users is expected to be low. Further, it is also
anticipated that building owner/operators are unaware of the PCB
problem and the extent to which their equipment may contain PCB’s
These considerations suggest that the inspection efficiency for
commercial buildings wil]. be so low as to require many hundreds of
inspections to achieve a significant level of compliance.
1 Although the cost of a joint transformer and capacitor inspection
is known to be greater than the cost of a transformer inspection
alone, the exact cost is currently unknown. Thus it was assumed
that a joint inspection required 50 percent more resources than a
transformer inspection.
2 The 500 available inspections were assumed to be joint inspec—
t ions.
—3
-------
It is reasonable to assume that when disposal of CB
equipment is required, many commercial buildings will contract for.
disposal services from transformer and capacitor service com-
panies. Thus, it is recommended that fifty inspections be
directed to-the organizations 1 in the U.S. who offer such 4isposal
arid replacement services to commercial.buildings. As discussed in
C1 apter II, it is estimated that PCB equipment in commercial
buildings will be removed from service in greater quantities in
later years. Thus, this inspection level should be increased as
the peak decision period approaches. Such an increase will
strengthen the integrity of proper disposal methods in service
organizations, thus maximizing the amount of PCB. equipment present-
ly in commercial buildings that is disposed of properly. Activi—
ties on these inspections shou.14 include both examination and
verification of records concerning work completed and review of
procedures being utilized for the removal, storage and disposal of
PCB’ S.
RAILROADS
Currently there are over 800 PCB transformers contaix ing
over 3.2 million pounds of PCB’s in electric locomotives. These
locomotives are owned by only six of the railroads in the U.S.
Further, these PCB’s are mandated for removal by 1982. This
accelerated schedule will require intensive effort in the nex t
several years to insure proper disposal of these PCB fluids. This
effort must be intense enough to insure that C3’s’in these mobile
and widely distributed pieces of equi nent are riot subject to
improper disposal. Thus, twenty inspections are targeted for
railroad shop inspections to insure that all, owners of PCB
1 ’Approximately 30 t 50 such organizations are thought to exist by
Versar, Inc.
— I
-------
transformers in locomotives are inspected at least once each r
until the last of the PCB equipment is removed from service in
1982. Activities on these inspections should include both
examination and verification of locomotive transformer records and
review of procedures being utilized for removal, storage and
disposal of PCB’s.
______ A2 D caisis RESPONSE
The remaining thirty inspection available shou l& be
reserved for emergency situations that arise due to - reports of
improper PCB disposal or handling. Inspections should be orde:ed
upon an evaluation of the emergei cy sit tion by appropriate EPA
enforcement personnel.
-------
Ex1’ bit E 1—i
THEORETICAL VS. REAL WORLD COMPLIANCE BE1 AVICR
100%
0
U
Required
100%
Probabi,l ity
of Inspection
FIGURE A: THEORETICAL BEHAVIOR
PCB’ S
Properly
Disposed
100%
Probability
Of Inspection
C3’ s
roperly
isposed
100%
0
0
A
Requirea
Before
Adjustnent
FIGURE 3: ACTUAL BEHAVIOR
-------
TEEORETICAL VS. REAL WORLD COMPLIANCE BEHAVIOR
(continued)
100% — —
PCB’ S
Properly
Disposed I
0
b
Required Required 100%
• Before After Probability
djus nent Adjustment of Inspection
FIGURE C: LIN APPROXIMATION
-------
ADJUSTED REX)UIRED PROBABILITIES OF INSPECTION 1
LT ILITIEB AND INDUSTRIAL TARGET GROUPS
(Annual)
INDUSTRY
TMU3E7 GROUP
REQUIRED PROBABILITY OF
INSPECTION FOR:
! ?ANSFO1 MERS CAPACI 1ORS
INDUSTRY
TAROET GROU
REQUIRED PRCUABILITf OF
INSPECTION FOR:
ThANSFORMERS CAPAC FlORS
UTILITI ES
Lbp 4 Companies
Next 4 Companies
Next 12 Companiea
Next 30 Companies
Remaining Compante
ALJIOZ’IDBILE
1 Tbp 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
i p 4 Companies
Next 4 Companies
Next 12 CompanIes
Next 30 Companies
Remaining Companies
3.0%
METAL 3.0%
1 p 4 Companies
Next 4 Companies
Next 12 Conpanie .
Next 30 Companies
I emaining Companies
TEXTI LES
‘lbp 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
1.2%
0.8%
0 • 8%
0.4%
0.00%
S1 E, CLAY & GLASS
¶Dp 4 Companies
Next 4 Companies
Next 32 (irnpaniea
Next 30 Companies
REmaining Companies
PAPER & LUMBER
¶i’Dp 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companie
MINING
¶Ibp 4 Companies
Next 4 CompanIes
Next 12 Companies
Next 30 Companies
Remaining Companies
CHEMICALS
¶D p 4 Companies
Next 4 Companies
Next 12 Cowpanieá
Next 30 Companies
Remaining Companies
3,0%
3.0%
1.7%
1.1%
0.8%
0• 3%
0.1%
2.1%
1.5%
1.4%
1.0%
0.1%
0.3%
0.3%
0.3%
0 • 3%
0.3%
5.3%
4.2%
4.7%
2.3%
0.3%
3 • 0%
3,0%
3.0%
3.0%
7.9%
7.9%
7.9%
7.9%
7.9%
19 • 3%
5 • 5%
0.4%
0.2%
0.1%
0 • 5%
0 • 5%
0.4%
0.3%
0.05%
9.0%
7 • 5%
3.9%
2.0%
0.3%
3 • 0%
‘probabilities are those required to insure the proper disposal
of all of a t arget group’s PC&s. Probabilities have been aijusb
for behavioral factors. Probabilities are expressed as a percent
target group transformers for ICB transformers and as a percent
of target group plants for capacitora reflecting differences in
the compliance decision for each. See Appendix C for a detaIled
discussion of the derivation of these probabilities.
-------
COMPUTATION OF IIISPECTIOM RFCjJIREMENTS AND INSPECTION EFFICIF CIE8 FOa TUE CHEMICAL INDUSTRY
TARGET GROUP
¶Ltp 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
RE tJIRE1 1
PR0BABILIT ( OF
INSPECTION
5 • 3%
4,2%
4.7%
2.3%
0 • 3%
NUMBER OF?
PLANiS
495
258
311
466
14Q1
ItEQUIRED 8
NISIBER OP
PLAWF
INSPECTIONS
26
11
15
11
4
ECB’S iU
TARGET GROUP
(mm lbs.)
6.86
2.86
3,81
2.75
1.13
0.264
0.260
0.254
0.250
0.283
1 Source: Exhibit IV-1.
2 Source: Exhibit 11—2.
3 source: Exhibit 11—4.
4 nequired Number of Plant Inspections
(Required Probability of Inspection x
Ni.mther of Transformers) + Transformers per Plant.
See Appendix C for further discussion of this
calcula Lion.
5 1CB’s in Target Group Number of Transformers
x ‘ 9 Pounds per Transformer,
6 lnspection Efficiency I C R ’s in Target Group
Required Number of Inspections.
7 Source: Appendix A,
BRequired Number of Plant Inspections
Required Probability of Inspection x
Number of Plants.
9 Source; Appendix A.
TRAflSFORMERS
TARGET GROUP
! [ bp 4 Companies
Next 4 Companies
Next 12 Companies
Next 30 Companies
Remaining Companies
CAPACITORS
RQ)UIRED 1
PEC 3ABIL1 OP
INSPECTION
NUMBER OF 2
TRANSFORMERS
TRANSFORIIERS 3
PER PlANT
RI IUIRED 4
NUMBER OF
PL R1Y
INSPECTIONS
I ” - .
TARGET GROUP
(nun lbs.)
3%
5755
11.6
15
11.34
0.756
3%
2395
9.3
8
4.72
0.590
3%
3199
10.3
9
6.30
0.700
3%
2308
5,0
14
4.55
0.325
3%
949
0.7
42
- 1.89
0.045
INSPECTION EFFICID CY
( nun lbs. PCB/Inspectio
INSPECTION EFFICIEtXY 1
( nun lbs. PCB/Inspectioi
-------
AD.7US REQUIRED Nt MBER OF Th SP!XTLLON
TO I tJRE T PROPER DISPC AL
OF ALL OF CH ET CUP’ S ECB’ S
A US REQUIRED
NUMBER CF INSPECTIONS —
I DT3S Y ET CDP N kM S PACfl !CRS
UT I ‘lbp 4 Campanies Li. 29
Next 4 Companies 7 is
Next 12 Companies 3.3 36
Next 30 Companies - 18 47
P riing Companies 29 77
A TCMOBU bp 4 Companies 2 11.
Next 4 Companies 1 1
Next 12 Companies 1 1
Next 30 Companies 1 1
i aining Companies 3 1
PCCD Tbp 4 Companies 21 4
Next 4 Companies II 2
Next 12 Companies 14 2
Next 30 Companies 20 2
ain.thg Companies 299 5
LS Tbp 4 Companies 12 36
Next 4 Companies 4
Next l2Cozrpanies 3
Next 30 Compan.tes 10 7
aining Companies 66 7
CHEMICALS T p 4 Companies 14 24
Next 4 Companies 7 10
Next 12 Companies 8 14
Next 30 Companies 13 10
P naining Companies 39 4
-------
AD US R UIRED NU’I8 OF SP TION
TO INSURE T P PER DI CSAL
OF ALL OF FA ‘ ET CraP’ S C3’ S
ADXST RD UIP
NL 1 OF INSPECTICWS
INDUS ET t CDP ‘ fl ANSFOWERS PACITORS
T ILES 1 p 4 Companies 8 3
Next 4 C npanies 5 1
Next l2Coxnpanies 9 2
Next 30 Companies 14 2
R uainir g Companies 65 2
S LCNE, CL 1 Itp 4 C ani.es . 10
& CI?SS Next 4 Companies 5 2
Next 12 Companies 7 2
Next 30 Companies 9 1
nainir Companies 38 2
PA2ER & TOp 4 Companies 13 8
L 1B Next 4 Companies 8 5
Next 12 Companies 14 6
Next 30 Companies 16 5
Remaining Companies 264 8
TOp 4 Companies 51 5
Next 4 Companies 23. 2.
Next 12 Companies 23 2
Next 30 Companies 93 2
1 !nainir Companies —
-------
RECOMMENDED INSPECTION SCEEDULE
UTILITIES AND INDUSTRIAL TARGET GROUPS
NUMBER OF NUMBER OF
SEOTOR OR . OINT TRANSFORMER
INDUSTRY TARGET GROUP INSPECTIONS INSPECTIONS
UTILITIES Top 4 Companies (360)1 11
Next 4 Companies (216) 7 —‘
Next 12 Companies (446) 13 —-
Next 30 Companies (571) 18 —
Remaining Companies (943) 29
TOTAL 78
AUTOMOBILE Top 4 Companies (58) 2
Next 4 Companies (ii.) 1
Next 12 Companies (17)
Next 30 Companies (30) — —.
Remaining Companies (116) —
TOTAL 3 —
FOOD Top 4 Companies (787) 4 23
Next 4 Companies (393) 2 ii.
Next 12 Companies(548) 2 16
Next 30 Companies (759) 2 —•
Remaining Companies (11,562) 6 —.
TOTAL 16 50
METALS Top 4 Companies ( 8) 12 — .
Next 4 Companies (137) 4 —
Next 12 Companies (277) 8 —
Next 30 Companies (327) 8 2
Remaining Companies (2,201) 8 44
TOTAL 40 46
1 Numbers in parentheses indicate n nber of plants in target
group.
-------
RECOMMENDED INSPECTION SCHEDULE
UTILITIES AND INDUSTRIAL TARGET GROUPS
(continued)
NUMBER OF NUMBER OF
SECTOR OR JOINT TRANSFORMER
INDUSTRY TARGST GROUP INSPECTIONS INSPECTIONS
TEXTILES Top 4 Companies (236) 4 4
Next 4 Companies (149) 2 3
Next 12 Companies (249) 2 7
Next 30 Companies (419) 2 12
Remaining Companies (2,054) 2 —
TOTAL 12 26
STONE, CLAY
AND GLASS Top. 4 Companies (366) .6 4
Next 4 Companies (169) 2 3
Next 12 Companies (237) 2 5
Next 30 Companies (316) 2 7
Remaining Companies (1,404) 2 —
TOTAL 14 19
PAPER AND
LUMBER Top 4 Companies (452) 10 3
Next 4 Companies (316) 6 2
Next 12 Companies (509) . 8 6
Next 30 Companies (588) 6 10
Remaining Companies (9,436) 10 —
TOTAL .40 2.1
MINING Top 4 Companies (1,620) 6
Next 4 Companies (660) 2 —
Next 12 Companies (720) 2 —
Next 30 Companies (3,000) 10 —
Remaining Companies — —
TOTAL 20
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RECOMMENDED INSPECTION SCEEDULE
U ?ILITIES AND INDUSTRIAL TARGET GROUPS
(continued)
NUMBER OF NUMBER 0?
SECTOR OR JOINT TRAN5 ’ORMER
INDUSTRY RGET GROUP INSPECTIONS. INSPECTIONS
CHEMICALS Top 4 Companies (495) 14
Next 4 Companies (258) 7
Next 12 Companies (311) 8
Next 30 Companies (466) 12
Remaining Companies (1,401) 4 35
TOTAL 45 36
TOTAL NUMBER OP
JOINT INSPECTIONS 265
TOTAL NUMBER OF
TRANSFORfrIER INSPECTIONS = 202
EQUIVALENT NUMBER OF
JOINT INSPECTIONS
IN PROGRAM 398
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• V UPdatin r Procedures
This chapter outlines procedures for measuring the
overall effectiveness of the PCB enforcement strategy, for
interpreting these results in the light of the changed conditions
or . new information and, finally, for altering the enforcement
strategy in response to these new conditions or information.
These updating procedures rely on data collected by EPA inspectors
during the inpect.ion process and on new economic data which may
become available to the EPA staff in the Office of Enforcement, as
well as on changes in the PCB regulations which may arise. The
sources and types of data likely to become available are discussed
in .the last section of this chapter.
MEASURING OVERALL EFFECii v iESS
As •discussed above, the objective.of .the enforcemf
strategy is to maximize the quantity of PCB’s that are disposed o
properly. Given, this objective. and. based on a nt nber of assump-
tions, PHB has recommended an enforcement strategy. As a first
step in the updating procedure, it is important to assess whether
or not the strategy implemented by the Office of Eaforcenent has
met the objective. 1
1 The updating procedure assumes that the objective of maximizing
the amount of PCS’s disposed of properly is an appropriate objec—
t ve. After the initial implementation of the en forcement strat-
egy, EPA should assess the soundness of this objective. To assess
the soundness of the underlying objective, EPA should review the
number and type of violations detected by inspectors. This
review, together with discussions with EPA inspectors, should
enable the Office of Enforcement to judge the appropriateness of
the objective of the enforcement program. For example, if review
of this information revealed that more PCE’s entered the environ-
ment through spills rather than improper disposal, the EPA should
restate the aim of its enforcement strategy and redirect its
efforts to ensure proper maintenance, of PCB equipment while
service.
—49
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Two measures of effectiveness are recommended. ThE
first is a measure of overall effectiveness of the enforcement
strategy for each industry and sector. The second is measure of
the specific level of effectiveness observed within each target
group. The methodology for calculating each of these measures i
given below.
Measure of Overall
Effectiveness
The overall effectiveness of’ the enforcement strateg
within each industry and sector can be measured by computing e
percentage of the PCB’s removed from service which were disposec
of properly over the past year. l To measure this percentage, thE
quantity of PCB’s disposed of properly should be divided by ar
estimate of the total amount of PCB’s removed from service. ThE
following methodology .can be used to measure the overaU
effectiveness of the enforcement strategy for each industry oi
sector:
1.: Recompute the PCB’ s removed from
service in each industry and sector over the
past year using the inspection results on the
number of transformers and capacitors in
service, the age distribution of the
remaining transformers and capacitors, and
the computer model discussed in chapter II
which projects the PCB’s removed from service
each year.
STEP 2: Calculate the PCB’ s disposed of in
CWLE”s and incinerators by each industry and
sector over the past year using data from the
RCRh manifest reporting system. 2
1 For the purposes of discussing the updating procedure, it i
assumed that the enforcement strategy is updated annually
However, the strategy should actually be updated when new inforina’
tion necessitates substantial changes in the underlying assump
tions.
2 Prior to the startup of the RCBA system, record inspections wil
be the source of this information.
c i
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STEP 3: Divide the PCB’ s disposed of in
CWLP’S or incinerators by the projected
amount of PCB’s removed from service ‘for a
measure of overall effectiveness for each
industry and sector.
These three steps yield the percent of. PCB’s removed from service
whl.ch. were disposed of properly over the past year as a measure of
the overall effectiveness of the enforcement program.l
Measures of Effectiveness
by Target Group
The effectiveness of the enforcement program within each
target group can also be measured from the inspection results. To
measure this ef. c iveness the nber of transformer violations of
all types detect should be divided by the n ber of tr3nsformers
inspected. For capacitors, the number of capacitor violations of
all types detected should be divided by the number of plant
inspected. 2 SubFy cting these effectiveness measures frcin 1.0
will yieldS the portion of the transformers inspected which are in
compliance and the portion of the plants inspected which are in
compliance with the PCB capacitor regulations. 3
1 Since the amount of PCB’ s disposed of in landfills and
incinerators is an actual reported figure and the PC ’s removed
from service is a projection, the overall effectiveness measure
may indicate that more than 100. percent of the PCB’s removed from
service were disposed of properly. Should this occur, the
assumptions underlying the removal from service projections should
be reexamined. For example, a measure which exceeds 100 percent
may indicate premature disposal of PCB equipmentT that is,
equipment disposed of before it fails or reaches the end of its
service life.
2 Recal2. that the compliance decision is assumed to be made at the
individual transformer level for transformers but at the plant
level for capacitors.
3 Care must be taken to insure that multiple violations related to
one transformer or one plant in the case of capacitors are treated
as one transformer or plant not in compliance. This will prevent.
double counting of instances of noncompliance.
—51—
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The recommended number of inspections to be performed in
some target groups is very snail. The estimates of effectiveness
may, therefore, be inaccurate due to small sample size. Appendix
F explains how confidence intervals can be established for these
effectiveness measures.
Interpreting the Measures
of E fcctiveness
After calculating the measures of effectiveness for each
sector or industry and for each target group and before revising
the enforcement strategy, the difference between the actual
effectiveness and the expected effectiveness should be explained. 1
For example, if a target group was inspected up to its required
rate of inspection, the EPA. would expect to find 100 percent o
the plants in compliance. If the raeasure of effectiveness based
on the ntber o violations detected revealed only a 65 percent
compliance level, the source of this difference should be
identified.
The difference between the expected and actual effective-
ness can be divided into two variances:
1. The variance due to changing economic
conditions, and
2. The variance due to the noneconomic factors
considered in the decision to comply.
1 Either measure of actual effectiveness —— the overall or target
group —— can be used when interpreting the difference between
actual and expected effectiveness. The measure selected should be
based on the perceived quality of the data and on data
availability.
— 5- 2—
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Each of these variances between the expected and actual is dis
cussed below.
VARIANCE 1: Economics
of Compliance Decision
The economics of the compliance decision may have
changed due to revised estimates of the distribution and average
age of PC3 equipnent, new estimates of the cost of compliance and
actual amounts of the assessed penalties. changes in these three
factors will alter the economic tradeoff of compliance versus
noncompliance. This, in turn, wiLl, alter the required probability
of inspection.
The distribution and averag1 age of PCB equipment
developed for this initial strategy are based on extremely limited
data. Therefore, as additional information become ayailablr
through inspections, these data should b used to modify th
initial distribution by replacing the original estimate of the
number of transformers per plant and the number of capacitors per
plant with the average number found in the inspected plants. The
original estimate of the average age of this PCE equipment should
be replaced with the average age observed in the inspected
p lants. l.
The cost of compliance wifl. also change as incinerators
are granted permits and as CWU”s are permitted to store these
hazardous materials. In addition, EPA may have actual data on the
1 For some target groups, these new estimates may be based on only
one or two plants. Even though the sample sizes are small, these
data are still preferable to estimates based on no empirical data.
Appendix F discusses the calculation of confidence intervals for
these estimates.
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average amount of the assessed penalty per violation. This
information will alter the economic tradeoff of compliance versus
noncompliance. Therefore, the inspection effectiveness level for
a given target group may be lower or higher than anticipated due
to the altered economic cond.it ions.
To calculate the difference between predicted and actual
effectiveness due to the change in economic factors, the required
probability of inspection should be recalculated for each target.
group for both transformers and capacitor . This calculation
should use the new data on cost of compliance and penalty amounts,
as well as the new distribution of transformers and capacitors per
plant. The ratio of the actual inspection probability to the new
required probability of inspection 1 is the expected level of
compliance based on the new economic information. For example,
assume 3 percent of the plants were inspected. If using. the new
economic data, the required probability of inspection should have
been 4 percent, the level of compliance expected would be 75
percent (3 percent divided by 4 percent). The change i economic
factors, therefore, accounts for 25 percentage points of the
difference between the actual and expected levels of compliance
within a target group.
VARIANCE 2: Accounting
for Noneconomic Factors
After calculating the first variance, any residual.
variance is asst ned to be the result of estimation error in the
noneconomic factors which influence decision makers. The
difference between the expected level of compliance calculated
with revised economic data and the actual level of compliance is
the second variance —— the variance between actual and expected
1 o insure the proper disposal of all of a tatget group’s PC ’s.
— 5 4—
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levels of compliance not accounted for by economic factors. Fe”
example, if the new required risk of inspection was 4 percent,
75 percent level of compliance would be expected at an actual
inspection rate of 3 percent (3 percent divided by 4 percent). Lf
the actual compliance level was 65 percent, the remaining 10
percentage point variance (75—65 percent) is assumed to result
fr&n inappropriately accounting for the noneconomic factors which
influence the decision to comply.
This variance could arise if the target group’s
communication network or their awareness of the PCB problem was
overestimated or underestimated. Also this variance could result
from over or underestimating the importance of these noneconomic
factors.
UPDATING TEE
1PORCE 1ENT STRA TEGT
The procedures describ d below are designed to enaL
the EPA to update the enforcement strategy to account for new
information and changing economic conditions. The information
gathered by the inspec €ors and available to EPA from other sources
should be used to modify both the awareness and the inspection
component of the enforcement strategy. Again, the objective of
the enforcement strategy is to maximize the amount of BCE’ s
disposed of properly.
Updating the
Awareness Component
The awareness component has two parts. The first part
is aimed at achieving a baseline level of awareness in all
industries and sectors regarding the PCB regulations, the actions
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C3 equipment user must take to comply with the regulation and
ianctions available to the EPA in tile case of noncompliance.
e aim of the second part is to support the enforcement effort.
modify the awareness component of the enforcement progr xa, EPA
ou.Ld review the measures of effectiveness for each target group,
:dustry and sector. The variances discussed above should also be
viewed. New awareness efforts should be concentrated on those
trget groups where the noneconomic variance accounts for a large
trt of the difference in actual versus expected effectiveness. 1
In addition, the EPA should review the number and type
detected violations in each industry or sector and draw out the
ispectors’ judgement concerning the level of awareness which
istz within the different industries and sectors. Based on this
formation, EPA should redirect some.of the awareness resources
ward industries and sectors where a large number of violations
“red, particularly where it appears that these violations were
:esult of ignorance. Some resources should also be directed
ward industries or sectors where awareness is judged to be poor
zen though few violations have been detected.
Updating the
Inspection Component
The inspection component ot. tne eniorcemen scracegy is
esigned to create a perceived risk of inspection which wili.
qualize the economic cost of compliance and the economic cost of
These awareness efforts should concentrate on informing firms
out the economic factors which should impact their decision to
cmply including the cost of compliance and the possible penalties
or noncompliance.
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noncompliance. Due to EPA’ s limited inspection resources, it is
not possible to inspect each target group at the required rate of
inspection. Thus the inspection resources were allocated to
maximize the rn uber of pounds of PCB’s p’roper].y disposed. To do
this, the inspection resources were allocated to target groups
based on the average n nber of PCB transformers and capacitors per
plant, the required rate of inspection to insure compliance in the.
target group, and the cost of an inspection. 1 As new data become
available, each of these inputs should be updated to reflect the
current data. and the inspection resources should be reallocated.
To update the inspection procedure, the required risk of
inspection must be recalculated based on the new estimates of the
distribution of PCB equip ent, new estimates on the cost of
compliance and actual data on the penalty amounts asse&sed. This
required risk of inspection is then adjusted as before for
noneconomic factors. Finally, this adjusted required risk o
inspection is readjusted again to account for the second variance
(the variance between expected and actual levels of compliance due
to estimation error in the noneconomic factors). Using these
final adjusted required risks of inspection, new inspection
efficiencies are calculated and the •computer model is rerun to
reallocate inspection resources to target groups.
1 As discussed in Chapter IV, two types of inspections were con-
sidered — a transformer inspection and a joint inspection. It
was estimated that. the cost of a joint inspection would be 150
percent of the cost of a transformer inspection.
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The following proce i.ire can be used to update the inspec-
tion component of the enforcement strategy.
STEP 1: Recompute the average number of
transformers and capacitors per plant in each
target group using the data gathered in the
inspections.
STEP 2: Using the new estimates of cost of
compliance and the average amount of the
penalties actually assessed, recompute the
required risk of inspection necessary to make
the target group members economically prefer
compliance with the PCB disposal regula-
tions. 1
STEP 3: Adjust the required risk of inspec-
tion for each target group for the non-
economic factors as was done in the initial
strategy 2
STEP 4: Compute the variance between ex-
pected versus actual effectiveness due to
estimation-error in the noneconomic factors. 3
1 See Appendix C for a detailed explanation of the calculation of
this required risk of inspection.
2 See Appendix D.
3 As explained previously, to compute this variance:
• Compare this new adjusted required risk of .inspection to
the actual inspection rate. Project the expected
effectiveness of inspections for each target group by
dividing the actual rate of inspection by the adjusted
required risk calculated in Step 3.
• Subtract the actual measure of effectiveness from the
expected effectiveness of inspections. This difference
represents the variance due to improper adjustment for
noneconomic factors.
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STEP 5 f the variance due to noneconomic
factors is relatively small, adjust the
required risk of inspection by multiplying
this risk by one plus the variance. 1
STEP 6: Recompute inspection efficiencies
using the new adjusted required risks of
inspection and the revised estimates of the
number of transformers and capacitors per
plant for each target g roup. 2
a’ 7: RUn the computer model to reallocate
the availabl-e inspection resources given the
new inspection efficiencies and the relative
costs of joint and transformer inspections. 3
Steps 1 through 3, 6, and 7 invoive updating calcula tions already
performed to arrive at the recommended inspection component and
are described in the previous chapters and the Appendices. Steps
4 and 5, however, are unique to the updating proced zre and an.
example will help clarify these steps.
Assume that recomputing the adjusted required risk of
inspection given the new cost of compliance and assessed penalties
yields an adjusted required risk of inspection of 4 percent. If
the target g:oup’s actual rate of inspection was 3 percent, EPA
would expect their inspections to be 75 percent effective (3
percent divided by 4. percent); that is, 75 percent of the PCB’s
1 1f the expected effectiveness of the inspections is not rela-
tively close to the industry or sector’s measure of overall
effectiveness, the assumptions concerning the economic and/or
noneconomic factors affecting the decision to comply may be
inaccurate. Discussions with inspectors and industry representa-
tives should be held to determine the accuracy of these assump-
tions.
2 See Appendix D.
3 See Appendix E for a description of this computer model.
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removed from service in this target group were disposed of
properly. If the measure of actual effectiveness discussed above
was 65 percent for this target group, they did not perform as well
as expected. The variance due to mproper1y accounting for
noneconomic factors is, therefore, 10 percent.
To alter the adjusted required risk of inspection the
risk, is wu.Ltiplied by one plus the variance. Thus, the new
required risk of inspection is 4.4 percent (4 percent multiplied
by 1.10). This rate is then used tç recalculate inspection
efficiencies as discussed in chapter IV and. Appendix D.
While this adjustment is reasonable if the variance due
to noneconomic factors’ is small, it should not be used if the
expected and actual effectiveness measures are very different. If
the measures differ significantly, the assumptions underlying the
computation of required inspection rates should be investigated.
INFORI4ATION FOR UPDATING
THB ENFOR E14ENT STRATEGT
Dpdatir.g the enforcement strategy requries that new
information be gathered from inspections and other sources. The
new information likely to be available to EPA can be categorized
as follows: -
1. Updated econom.tc information on the cost of
compliance, the amount of. the penalties
assessed for noncompliance and the available
EPA resources. This information is gathered
by EPA and based on changes in current
conditions such as the permitting of an
incinerator, ‘. alterations in the penalty
policy, and changes in the Office of
Enforcement’s budget. for PC3 enforcement.
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2. PCB quantity data gathered in the field.
This information comes from the EPA inspec-
tion program and the RCBA manifest reporting
system which •requires all chemical waste
landfills (C cLZ’S), incinerators and waste
handlers to report on the hazardous wastes
transported, treated or disposed each year.
The first category of information wiLt enable EPA to
reassess the economic tradeoffs of compliance versus noncompli-
ance. The second category of information will allow EPA to set up
a racking system for PCB transformers and capacito:s and to
better estimate the amount of PCB equipment in each sector and
industry, as wel]. as when this equipment is likely to be retired.
Together this information can be used o measure the overall effec-
tiveness of the enforcement strategy and to modify the strategy.
The data. which should be gathered during an inspection
and the data available from the manifest repcrting system are
described below. Exhibit V—i details the data required to update
the enforcement strategy, the source of the data and the Office o
personnel who should be responsible for .collecting this data.
Inspection Data
The EPA inspector . is in the unique position of being
ab Ie to physically verify the existing equipment in the plant.
Since the allocation of inspection resources relies heavily on an
estimate of the number of transformers and capacitors in each
target group’s plants, it would be desirable to update these
estimates. The inspector also may be able to infer from the
plant’s records or from physical. inspection of asaznple of the PC8
equipment, the age of the-PCB equipment arid hence, the likely date
of the equipment’s removal from service. The inspector will also
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keep a record of the number and type of violations detected at
each plant. Therefore, at a minixaurn, the inspector should gather
the following information:
the number of Pc transformers and capacitors
in service in each plant,
the age of each transformer and capacitor in
the plant, l and
the number and type of violations detected.
As discussed above, the inspectors’ views of the plant manager’s
awareness of the PC3 regulations and other qualitative data are
also useful when updating the enforcement strategy.
Manifest Reporting System
The manifest reporting system will require all
generators, transporters and disposers of hazardous waste to
report on the amount, type. and source. of hazardous waste handled
each year. This system is designed.to track all hazardous wastes
and hence, to detect violations by checking for discrepancies in
the data. This system will allow EPA to keep a record of all
PC3’s disposed of properly in CWLP’s or incinerators by each
target group.
1 The law does not require that age be reported. .If these data are
unavailable, the inspector should estimate the age distribution of
the transformers and capacitors in the plant or, at a minimum, the
average age of all PCB transformers and the average age of all PCB
capacitors in the plant.
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INFORI•IATION FOR UPDATING
TIlE ENFORCEMENT STRATEGY
OFFICE/PERSONNEL
RESPO TSIBLE. FOR
INFCRMATION SOURCE COLLECTING INFORMATION
Average number of Inspections EP Inspectors
PCB transformers
and capacitors per
plant
Age distribution Inspections EPA Insp ct . :s
of PCB equipment
Number and type Inspections EPA Inspectors
of violations -
PCB’s disposed of. RCBA Manifest Office of Eazardous
properly Reporting System l Wastes
Cost of compliance Estimates by EPA Office of -
or EPA Contractors Enforcement
Cost of inspections Office of Office of
Enforcement Enforcement
Amount of Office of Office of
penalties assessed Enforcement Enforcement
EPA resources Office of Office of
Enfárcement Enforcement
1 lnspections will be the source of this information prior to the
startup of the RCRA system.
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Io S1 4
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASH INGTON, D.C. 20460
4(
.H 1 3
Pt$TICIDES AND TOXIC SUDSYANCES
MEMORANDUM
SUBJECT: Amendment to the Compliance Monitoring Strategy
for TSCA §6(e) - Polychiorinated Biphenyls (PCBs)
FROM: A. E. Conroy II, Director
Office of Compliance Monitoring
TO: Addressees
On July 1, 1985, the Agency amended portions o ’the existing
rules concerning the use of polychiorinated biphenyls (PCBs)
by placing additional restrictions and conditions on the use
— of PCB Transformers. This rule was published in the July 17,
1985 Federal Register and was effective on August 16, 1985.
The new rule is divided into two basic parts: 1) measures
which are intended to lower the frequency of PCB Transformer
fire incidents; and 2) measures which are intended to reduce
exposures in the event of a fire despite the implementation
of the measures to reduce the probability of failure.
This amends the May 23, 1985 Compliance Monitoring Strategy
for TSCA §6(e) - PCBs, (hereafter called the PCB Strategy) and
incorporates comments submitted on the September 12, 1985
draft amendment. The following is a summary of the comments
submitted and the Office of Compliance Monitoring’s (0CM)
response.
o Several comments indicated errors in the section
entitled “Summary of the PCB Regulation”. This has
been corrected to reflect the actual effective date
of the rule, the labeling of access areas rather than
exteriors of commercial buildings, the correct date
for registration of PCB Transformers in or near
commercial buildings and the requi rements for
installing enhanced electrical protection.
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-2-
o One comment indicated that only PCB Transformers in
commercial buildings must be registered. This is
incorrect; all PCB Transformers must be registered
with the local fire jurisdiction, and the strategy
reflects this.
o Several comments suggested that the violation categories
section be changed in the following areas:
- change the failure to contain water from a disposal
violation to a use violation;
- since there are no recordkeeping requirements,
change the failure to register PCB Transformers
with the fire jurisdiction from a recordkeeping
violation to a use violation.
0CM agrees that the failure to contain water after a
fire incident is a use rather than a disposal violation.
Also, the failure to report fire related incidents has
been moved into the use violation category as well
o One comment suggested that the types of violations in the
violation category section also be linked to a level or
extent category. The PCB penalty policy usually bases
charges on the type of violation and the amount of PCBs
involved, hence level and extent can only be identi —
fled for each specific violation and no generalization
is possible.
o Several comments suggested that the PCB Strategy expand
the industrial categories by including an additional
category for Commercial Buildings. The previous ten
industrial categories do not specifically identify
buildings/facilities covered by the Transformer Fires
Rule. 0CM agrees and has added an additional category
for Commercial Buildings.
o Several comments suggested that 0CM and/or the Office
of Toxic Substances (OTS) provide additional guidance to
the Regions regarding: What constitutes enhanced
electrical protection; What is meant by stored
combustibles; What is the difference between a Network
and a Radial Transformer. OTS is working to revise
the booklet entitled “The PCB Regulations Under TSCA:
Over 100 Questions and Answers to Help You Meet These
Requirements” in an effort to answer such Regional
questions. In the interim, 0CM has attached copies
of letters OTS has sent to Regions and regulated
industries regarding these questions and their answers.
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-3
o Several comments suggested that Attachment II outlining
compliance dates for railroad transformers and the reuse
of PCB Large High Voltage Capacitors and PCB Large Low
Voltage Capacitors which pose an exposure risk to food
or feed was unnecessary because most Regions have already
included such facilities in their neutral inspection
schemes. 0CM agrees and has deleted Attachment II.
o Several comments requested that the notification plan
that OTS developed for the PCB Transformer Fires rule
be included. 0CM agrees and has included the notification
plan.
If you have any questions regarding this amendment, please
contact David Hannemann of my staff at (FTS)382-7849.
Attachments
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ATTACHMENT 1
TRANSFORMER FIRES RULE AMENDMENT TO THE
COMPLIANCE MONITORING STRATEGY FOR TSCA §6(e)
POLYCHLORINATED BIPHENYLS
Summary of the PCB Regulation
o Polychiorinated Biphenyls in Electrical Transformers
July 17, 1985 FEDERAL REGISTER: 50 FR 29170—29201
Effective Date: August 16, 1985.
Summary: This final rule amends portions of an existing
EPA rule concerning the use of polychiorinated biphenyls
(PCBs) by placing the following additional restrictions
and conditions on the use of PCB Transformers (Electrical
transformers containing 500 parts per million or greater
PCBs).
- Prohibits the use of 480/277 or higher volt network
PCB Transformers in or near commercial buildings
after October 1, 1990;
- Requires, by October 1, 1990, the installation of
enhanced electrical protection on lower secondary
voltage network PCB Transformers (less than 480/277
volt), and 480/277 or higher volt radial PCB Trans-
formers in use in or near commercial buildings;
- Prohibits further installation of PCB Transformers in
or near commercial buildings after October 1, 1985;
- Requires the registration by December 1, 1985, of all
PCB Transformers with fire response personnel and
building owner;
— Requires the marking, by December 1, 1985, of the means
of access to all PCB transformer locations (the owner
of the PCB transformer is responsible for marking);
- Requires the removal , by December 1, 1985, of stored
combustibles located near (within 5 meters) PCB Trans-
formers; and
- Requires owners of PCB Transformers involved in fire-
related incidents to immediately notify the National
Response Center and to contain all potential releases
of water that could be contaminated following fire
related incidents.
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ATTACHMENT 1 - Page 2
Violation Categories —_______ ____—_______
Violations of requirements listed under the measures
designed to reduce the future frequency of fire-related
incidents are all considered use violations.
Violations of the requirements listed under measures to
reduce exposure in the event of a fire are all considered
use violations as well. -
Use - Owner fails to register PCB Transformers
with the local fire jurisdiction or the
building owners.
Owner fails to report all fire-related
incidents.
Owner fails to contain potential releases
of contaminated water after a fire-related
incident occurs.
Owner fails to remove stored combustibles
from the transformer area.
Owner fails to label the means of access
to the PCB Transformer location.
Each violation of this rule may be considered by the
Region as an individual violation subject to penalties under
the TSCA penalty policy published in the Federal Register of
September 10, 1980
Compliance_ObjTT ,Tf ____ ________________________ _____
No changes.
Inspections
Since the compliance monitoring strategy outlines target-
ting for PCB inspections based on a neutral administrative
inspection scheme using Regional PCB priorities, no major
changes to the PCB Strategy issued on May 23, 1985, are required.
However, since the new rule will impact many commercial
facilities, the Regional Offices are to amend their inspection
targets to include those commercial buildings that would be in
a more vulnerable situation in the event of PCB Transformer
fires. More emphasis and resources should be planned for the
inspection of these facilities because of the greater number
of people potentially at risk and the decreased degree of
expected awareness in the event of a fire-related incident.
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ATTACHMENT 1 - Page 3
Rel atively less emphasis should be placed on industrial
facilities since these are generally not public access
buildings and the individuals working in these facilities
would be expected to have a greater familiarity with the
nature of the equipment with which they work.
The amended neutral inspection scheme should contain a
large percentage of regional inspection resources for the
first two years after the effective date of the Transformer
Fires Rule - August 16, 1985. The percentage of inspections a
Region devotes to determining compliance with the “Transformer
Fires Rule” is to be between 15% and 25% depending on the
commercial category makeup within each particular Region. The
remaining inspectional resources should be allocated according
to the May 23, 1985 PCB Strategy. However, future inspection
schemes should include attention to the October 1, 1990 deadline
for enhanced electrical protection in commercial buildings and
for the removal of high secondary voltage network PCB Transform-
ers from commercial buildings.
In the short term, the Transformer Fires Rule required
three activities with December 1, 1985, deadlines. These
include registration of all PCB Transformers with fire response
personnel and building owners; the marking of PCB Transformer
access routes; and removal of stored combustibles from PCB
Transformer locations. The Regions should identify urban
areas within the Region where PCB Transformers subject to
these requirements are likely to be located to inspect for
compliance. These areas should be selected to assure that a
uniform geographic distribution is achieved for inspections.
The Regions should contact the local fire departments within
the identified urban areas to request copies of all registra-
tions filed with them for the locations and numbers of PCB
Transformers in or near commercial buildings. The Region may
be able to obtain the addresses of these local fire departments
from the State Fire Marshals. Such registration information
will provide important data on the number and locations of PCB
Transformers currently in use in or near commercial buildings
and allow the Region to determine the inspectional resources
needed to inspect commercial buildings.
In the long term, the collected registration information
will be useful in designing a strategy to inspect for the
removal of high secondary voltage network PCB Transformers in
commercial buildings and to inspect for the addition of
enhanced electrical protection by October 1, 1990.
Two years after the effective date of the Transformer
Fires Rule, the Regions may return to setting priorities as
outlined in the May 23, 1985 Compliance Monitoring Strategy
for TSCA 6(e) - PCBs. The Region should include inspectional
targets for the Transformer Fires Rule as part of their priority
setting after the second year, with emphasis on new requirements
in that rule as they become effective.
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ATTACHMENT 1 - Page 4
Neutral Administrative Inspection Scheme
In addition to the 10 industrial categories outlined in
the May 23, 1985, Compliance Monitoring Strategy for TSCA 6(e)
PCBs, this amendment adds a new category:
11. Commercial Buildings — Buildings which have public
access, e.g.: apartments, shops and malls, hospitals,
museums, airports, transportation centers, office
buildings, local, State and Federal government office
buildings, etc.
Allocation of Responsibilities
The Office of Toxic Substances developed a Notification
Plan which was included in the May 23, 1985 revision to the
PCB Compliance Monitoring Strategy. This Notification Plan
listed the names of and addresses of parties affected by the
rule who were sent information on the rule. This Plan will
provide the Regions with an initial information base from
which inspections can be targetted because it contains names
and addresses of individuals, groups or associations that
commented on the Transformer Fires Rule. (The Notification
Plan is Attachment 2)
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ATTkCHME14T2 -
PCB Tranformer Fires Final Rule: Notification Plan
Phase I : The first phase of the notification plan consists of
the distribution of certified copies of the final rule to all
litigants (past and present) in PC13 lawsuits (see attachment
#2). This includes the Environmental Defense Fund and the
Natural Resources Defense Council as well as the Edison Electric
Institute. OPTS will include a copy of the fact sheet as well as
a tentative date for the publication of the final rule in the
Federal Register.
Phase II : Phase II of the notification plan consists of railing
out published copies of the final rule to building owners and
managers, fire department associations, and state and local
government associations (see attachment #1). Published copies
will also be distributed to the litigants.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460 kY” 4’
t1 t.I O
OFFICE OF ENFORCEMENT
MEMORANDUM
SUBJECT: PCB Enforcement Policy Subsequent to App ellate Court Opinion
Remanding Portions of the PCB Regulation
TO: Regional Enforcement Directors and Branch Chiefs
On October 30, 1980, the United States Court of Appeals for the
District of Columbia Circuit issued the attached opinion in the appellate
case brought by the Environmental Defense Fund CEDE) against EPA. EDF had
challenged major portions of the PCB rule (44 FR 31514) issued on May 31,
1979 under the Toxic Substances Control Act. The Court struck down that
portion of the regulation which limited its application to 50 parts per
million or more PCB. The Court also set aside those portions of the rule
which define intact, non—leaking transformers, capacitors and electro-
magnets as totally enclosed uses of PCBs. For a discussion of the 50 ppm
cutoff, see pages 25—35 of the attached opinion. Enclosed uses are
considered at pages 35-40 of the opinion. Those portions of the regulation
relating to totally enclosed PCB uses and the 50 ppm cutoff were returned
to the Agency by the Court for “further proceedings consistent with this
opinion.”
At the same time, the Court upheld the eleven PC3 use authorizations
permitted by EPA. As the Court noted, the disposal and marking sections
of the PCB regulations were not challenged In the litigation. Therefore,
these regulations remain in effect, and enforcement activities relating to
the disposal and marking regulations should continue as before.
Representatives of the Office of Enforcement are meeting with the
Office of Pesticides and Toxic Substances and the Office of General Counsel
to develop the appropriate Agency response to the directives of the Court.
Our discussions with OPTS and OGC will focus on what Agency steps are
necessary prior to any enforcement policy involving the portions of the
regulations that were struck down. A further memorandum will be sent to
you shortly summarizing the results of those discussions.
In the meantime, you should continue all present enforcement activities
relating to PCBs in concentrations of 50 opm or greater. Nothing in the
C3urt’s opinion suggests that EPA’S present enforcement program with respect
to PCBs In concentrations of 50 ppm or greater should be halted. Civil
penalty complaints already issued are unaffected by the decision. Inspections
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should continue, and additional enforcement cases should be referred to
headquarters for concurrence. In addition, all inspection samples which
show any detectable amounts of PCBs, including amounts below 50 ppm, should
be retained until further PCB enforcement policy is issued by headauarters.
Enforcement should also continue against the use of PCBs in any detectable
amounts used as a sealant, coating, or dust control agent.
If you have any questions concerning this memorandum, please call
Jo m Lyon, Chief of t e Case Development and Legal Branch (telephone
755—8317), for additional information.
A. E. Conroy II ,
Pesticides and Toxic
Enforcement Div
Attachment
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€O
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
_____ WASHINGTON. D.C. 20460 -
-
- -
OFFICE CF EtIFORCEMENT
MEMORANDUM
SUBJECT: New Requirements for PCB Transformers Pursuant to
Appellate Court Order
TO: Regional Enforcement Directors and Branch Chiefs
I want to advise you of recent developments in the PCB
appellate case filed by the Environmental Defense Fund against
EPA. These developments will Impose new inspection and maintenance
requi: ’ nts for owners and users of PCB transformers beginning
In approximately two months.
Last November, I sent you a memorandum on the October 3b,
1980 opinion df the United States Court of Appeals for the District
of Columbia Circuit in this same PCB case. That opinion set aside
those parts of the 1979 PCB regulation (44 FR 31514) which catego-
rized PL8 transformers, capacitors and electromagnets as totally
enclosed PCB uses. The opinion also struck down that portion of
the regulation which limited Its application to 50 par ts per
million or more PCB.
During the past four months, the Office of Enforcement has
participated in discussions about the case with representatives
of EDF, industry and the Agency’s Office of General Counsel and
the Office of Pesticides and Toxic Substances. The discussions
have focused on what actions are appropriate in view of the Court’s
1980 opinion. Agreement emerged from these discussions that new
information was needed before further rulemaking could begin on
(1) whether uses of PCBs in tranformers, capacitors and electro-
magnets were totally enclosed uses and (2) appropriate regulation
of PCBs at levels below 50 ppm.
Therefore, the parties asked the Court to allow the 1979
regulation to remain in effect (categorizing PCB transformers,
capacitors and electromagnets as totally enclosed) for eighteen
months while Information is gathered on transformer, capacitor
and electromagnet characteristics and also on PCB manufacture at
levels below 50 ppm. The parties agreed that during this eighteen
month period only persons who adhere to an interim inspection and
maintenance program for Intact, non—leaking transformers should be
allowed to use PCB transformers under the 1979 regulation.
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should continue, and additional enforcement cases should be referred to
headquarters for concurrence. In addition, all Inspection samples which
show any detectable amounts of PCBs, including amounts below 50 ppm, should
be retained until further PCB enforcement policy is issued by headquarters.
Enforcement should also continue against the use of PCBs in any detectable
amounts used as a sealant, coating, or dust control agent.
If you have any questions concerning this memorandum, please call
o’in Lycr., Chief of t e Case Develoo ent and Legal Branch (telephone
755—8317), for additional Information.
A. E. Conroy II, D re tar
Pesticides and Toxic ub tances
Enforcement Div on
Attachment
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On February 12, 1981, the Court accepted the Inspection and
maintenance program proposed by EPA, EDF and industry. The Court
issued the attached order allowing use of intact, nonleakfng PCB
transformers, capacitors and electromagnets to continue for eighteen
months so long as owners and users follow the court-ordered inspection
program. The program is to become mandatory and enforceable sixty
days after publication of the Court’s order in the Federal Register .
Publication Is now scheduled for early March 1981.
In the meantime, you may wish to study the Court’s order to
become familiar with its terms. The inspection and maintenance
requirements (or interim measures program) is contained In Appendix
B to the order. The requirements are in addition to those contained
in the 1979 PCB regulation. Owners of PCB transformers (500 ppm PCB
or greater) and PCB contaminated transformers (between 50 and 500
ppm PCB) which pose an exposure risk to food and feed products must
inspect such transformers weekly. All leaks must be recorded and
moderate leaks (as defined on page 1 of Appendix B to the order)
must be reported to the appropriate EPA regional office within five
business days. Servicing of the transformer must begin within two
business days. Records must be kept (with required information as
described in Appendix B), and these records must be made available
to EPA upon request. -
Similarly, all other PCB transformers (500 ppm PCB or greater)
must be inspected every three months. All leaks must be recorded,
and servicing as a result of moderate leaks must begin within two
business days. Records must be kept and are to be made available
for inspection by EPA.
As stated earlier, these new requirements will not become
effective until sixty days after pubi I cation in the Federal Regi ster .
I wil I send you a further memorandum outlining our enforcement policy
as soon as the Court order is published.
If you have any questions concerning this memorandum, please
call John W. Lyon, Chief of the Case Development and Legal Branch
(FTS 755—8317), for additional information.
A. E. Conroy II Director
Pesticides and ToxtcJ4’bstanceS
Enforcement Division
Attachment
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OZJ 6 c. ?L.
IN TEE UNITED STATES COURT.OF APPEALS
FOR THE DISTRICT OF COLUMBIA CIRCUIT
No. 79—1580
Urnted States Court oi ::
fir the OWi ci Cclugebia C
ENVIRONMENTAL DEFENSE FUND, INC., FJLE a i 2 19 1
Petitioner
GEORGE A. FJSHE
V • G1.E K
ENVIRONMENTAL PROTECTION AGENCY-,
Respondent
AD HOC COMMITTE! LIQUID DIELECTRICS OF THE
ELECTRONIC INDUSTRIES ASSOCIATION,
NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION,
I OY MANUFACTURING COMPANY,
EDISON ELECTRIC INSTITUTE, et al., and
ALUMINUM COMPANY OF AMERICA,
Irttervenors
BEFORE: Edwards and Robinson, Circuit 3udges, and Corcoran, /
United States District udge for the District o
Columbia
ORDER
Upon consideration of the joint motion filed by respondent,
petitioner, and certain intervenors on January 21, 1981, to
stay further the issuance of the mandate in this case, it is
CRDERED, by the C3urt, that the m andate of the Court is
stayed for a period of eighteen rnonths insofar as the decision
of the Court set aside the regulation promulgated by the
/ Sicting by designation pursuant to 28 U.S.C. 32 2(a) (1976 .
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Environmental Protection Agency (classifying the use of
intact, non—leaking, PCB—containing transformers, capacitors,
and electromagnets as uses of PC3s in a totally enclosed
inanner, ) 40 CFR 761.30, 44 Fed. Req. 31530, 31531, 31548-4
(1979); this stay shall apply only where those claiming the
benefit of the stay comply with any applicable requirements
of the Interim Measures Program attached as Appendix B to
this Order.
Further ORDERED that the mandate of be Court, insofar
as the decision of the Court set aside the regulation proniul-
gated by the Environmental Protection Agency defining PCBs
.(for purposes of the statutory prohibition on further manu-
facture, processing, distribution in commerce, and use of PCBs)
a P Bs in concentrations of 50 parts per million or greater,
40 CFR 761.2(x), 44 Fed. Req. 31444 (1979), is stayed for the
following periods:
With respect to use of PCBs in
transformers, capacitors, and
electromagnets, for a period of
eighteen months;
With respect to all other manu-
facture, processing, distribution
in commerce and use of ?C s, for
a period of thirty days.
Further OR EBED that Intervenor Edison Electric Institute
undertake the actions set out in Appendix A to this Order.
Further OR EP.ED that Respondent Environmental Protection
Agency publish in the Federal Register, within three weeks
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after the date of this Order, an Advanced Motice of Proposed
Rulemaking relating to the use of PCBs in electrical equipment.
Further ORDERED that Respondent Environmental Protection
Agency promulgate a final rule with respect to the use of
electrical equipment containing PCBs within six months
of receipt of the material set out in Appendix A.
Further ORDERED that if the Edison Electric Institute or
the Environmental Protection Agency fails to comply with the
orders of this Court set out’ above, any party may apply to the
Court for appropriate relief, including the iediate issuance
of the Court’s mandate.
Further ORDERED that the parties submit to the Court a
status report on October 1, 1981.
Per Curiam
FOR THE COURT:
4 A
GEORCQA. FISHER
Clerk
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APPENDIX A
PROPOSAL TO SUPPLY EPA WITB INFORMATICN FOR RULEMAKING
ON USES OF PCBS BY TEE ELECTRIC UTILITY INDUSTRY
INTENT TO ?Rov:DE INFCRMATICN
To assist EPA in the development of an adequate rule-
making record for the regulation of PCBs, USWAG will retain inde-’
1/
pendent contractor(s), acceptable to EPA and EDF, to conduct
2/
a study on current PC! usage in utility equipment. •This study
will address the effects of the use of PCB—containing equipment
on human health and the environment. It is expected that data
will be supplied on: types of electrical equipment; leakage
phenomena, including the incidence and magnitude of leaks;
feasibility of containment, inspection and maintenance; and
feasibility of transformer and capacitor phase out. Addi—
ionally, several other areas of inquiry will be included,
such as the impact of a regulatory cutoff above or below 50
ppm; the health effects of PCBs; a pathway analysis for PCBs
that may be released into the environment from electrical
systems; nonelectrical materials potentially containing PC!s;
and viable substitutes foe’ PCBs. Finally, an overall economic
1/ To insure the timely commencement of the study, EPA and
— EDF will promptly respond as to the acceptability of the
contractor(s) proposed.
2/ Other uses of similar equipment by other industries may
— vary and for this reason will not be covered. In addition,
other equipment containing ?C3s, such as small capacitors,
that is used rnore,broadly throughout the industrial, com-
mercial and resid ’ntial sectors will not be included.
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analysis would be develcped to reflect both costs incurred to
date to comply with the ?SCA—PC3 regulations as well as the
3/
incremental costs of new regulatory approaches [
It is contemplated that the study will be completed
within nine months and portions of it will be submitted to EPA
4/
prior to that time. If it appears that USWAG will be unable
to complete Tasks 1 through 4 below within nine months despite
good faith efforts to do so, it may request of EPA and EDF
an additional period of up to three months form its work.
EPA and EDF will not unreasonably withhold their consent to
suèh extension, aft r considering USWAG’sefforts to date
and the circumstances which USWAG believes necessitate the
extension.
3/ In addition to the information contained in the study, TJSWAG
reserves the right to submit to EPA such other studies, in-
formation, and data •(e.c., problems of testing and develop-
ment of testing protocols) as SWAG believes are necessary
or appropriate to further rulemaking.
4/ Since some brief period of time will be necessary to
engage consultants and develop sampling protocols fol-
lowing acceptance of the scope of work by the parties,
the study period should commence no later than two
months following the issuance of a stay of mandate by
the Court. It is contemplated that Task 1 would be
completed within three months of the commencement of
the study and Task 2, with respect to PCB Capacitors
and PCB Transformrs, would be completed within six
months of the commencement of the study.
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SCOPE OF THE INFORMATION GATHERING EFFORT
The scope of information gathering wifl, be divided into
several discrete tasks, as set forth below.
1. Compilation of a complete listing of all types of electrical
eculoinent that conta ..n mineral oil or other fluid containing
PCBs .
The first task wifl. be to list and quantify such equip—
• 5/
merit, describe its use, geographical location, and’ distribution
of ranges of PCB concentrations. Descriptions of equipment main-
tenance procedures and of measures taken for worker protection
also will be provided. The inventory of equipment will include:
transformers, capacitors, electromagnets, electrical switches,
voltage regulators, and underground cable systems as well as
any other utility equipment identified as containing PCBs. A
complete narrative on each category of equipment will be prq—
vided covering its function, configuration and chemical content.
2. Frequency of leaks or ruptures .
For purposes of the study, “leak” will be defined quan-
titatively. Leaks may be described as small, as moderate or as
6/
ruptures. Small leaks include all instances in which a PCB
Article has any PCBs on any portion of its external surface, but
5/ Geographical location shall include not only various geo-
graphical regions of the United States but also various
types of terrains (e.1., deserts, swamps, near or over
waterways).
6/ Further differentiations of leaks may bt necessary.
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7/
no PCBs have run off the surface of the PCB Article. Moderate
leaks include instances in which a leak results in any quantity
of PCBs running off the surface of the PCB Article. Initially,
ruptures will mean leaks causing immediate cessation of equipment
function, although other definitions may be applied. For each
type of electrical equipment, an attempt will be made to deter-
mine the frequency of leak or rupture, the volume o liquid
lost, equipment type, and geographical location. These leaks
may conform to a frequency distribution of magnitude according
to different variables. Equipment type, geographic location,
age and electrical loading (to the extent data are available)
are factors to be evaluated. The relationship between equip—
ment failure and subsequent leaking will be studied.
3. Feasibility of a program to contain, inspect and maintain
different electrical ecuipment items .
This task will, be to identify a number of inspection
and maintenance programs and to provide cost estimates and tech-
nological feasibility evaluations with respect to each program.
Variables to be considered may include electrical equipment type,
geographical location, and potential for exposure to different
concentrations and quantities of PC3s. At a minimum, the follow-
ing programs shall be evaluated:
7/ PCB Article” is defined at40 C.F.R. S 761.2(t).
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(a) A program to provide complete containment
of any PCBs which might leak from each
category of electrical equipment identified
in Task 1.
(b) A program to inspect visually, at various
frequencies ranging from weekly to annual—
ly, all items within each category of elec—
trical equipment for leakage and to correct
all moderate leaks detected..
4. Feasibility of a phase—out program for transformers and
capaci.tors .
The approach to this effort will be similar to the
feasibility of inspection, maintenance and containment as de—
8/
scribed above. Alternative approaches will be assessed, in-
cluding the following:
(a) 2, 5, 10 & 20—year phase outs of PC! Tfansformers;
(b) 2, 5, 10 & 20—year phase outs of PCB—Contaxninated
Transformers;
9/
(c) 2, 5, 10 & 20—year phase cuts of PC! Capacitors.
In this aspect of the study, the availability of replacement equip—
10/
ment and liquids will be examined, as well as their suitability,
8/ The evaluation will also reflect the viability of substi-
tutes.
9/ The time frames will be measured from January 1982.
10/ For xaxnp1e, it may be necessary to assess the toxicity and
flammability of suostitute fluids, in addition to developing
data on the availability of equipment and raw materials.
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the availability of storage and dispcsal facilities, and the fea-
sibility of reducing or eliminating PCB concentrations by retro—
11/
filling. An attempt also will be made to analyze the effect
an increased demand for replacement equipment may have on prices.
5. Literature Search .
A comprehensive literature search and review of the
health effects of PCBs will be undertaken and an attempt will be
made to assess the risks posed by phenomena such as small leaks
and ruptures.
6. Pathway analysis .
An attempt will be made to examine the environmental path-
ways that PC3s could take if they escape from electrical equip-
ment. Conditions reflecting normal operation of transformers nd
capacitors will be evaluated, as well as those involving equipment
that has exploded or otherwise suddenly released PCB—containing
fluid into the environment. For example, volatility and trans-
port mechanisms (such as surface water drainage, groundwater in-
filtration and ground cover embodiment and/or release) would
be considered.
11/ In evaluating substitutes for PC!S, including retrofilling,
— the contractor performing the study shall seek and consider
information frcm mar.ufac urers of substitutes and indeper.—
dent servicing companies.
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7. Non—electrical systen ’ sources of PC s .
The study will also seek to determine the risks and
benefits of permitting the continuation of certain non—enclosed
uses of PCBs, such as burning of fuel oil.
SAMPLING PROCEDTJRES
The study must reflect a statistical approach that assures
a high degree of confidence in the validity of the results.
EPA AND ED? REVIEW
It is contemDlated that EPA, ED?, USWAG and the contractor
performing the study will meet for pr g zs reports periodically
and with sufficient frequency. to keep EPA and ED? abreastof the
progress of the study. EPA and ED?, at their own expense, will
have the right to review all underlying ta generated in co ec—
tiorl with the study. It is understood that identification of par-
ticular companies, facilities and locaticns may be masked. While
it is not anticipated, review of the ongoing study may result in
the need for additional infcrmation or for the refocusing of cer-
tain portions of this study. Such revisions may result in an
extension of the completion date as set forth above.
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APPENDIX B
INTERIM MEASURES PROCRAM
This documer.t describes the interim rneasures required
for all owners and users of PCB Transformers and certain owners
and users of PC3—Ccntaxninated Transformers who wish to continue
to use, or store for reuse, transformers containing PC3s while
EPA conducts further ruleinakinq with respect to PCB qses which
the Agency previously had designated as “totally enclosed.”
To continue to use transforrers containing PCBs during this
interim period, owners and users of this equiprient n’ust comply
with the requirements set forth in this document within sixty
days after the publication by EPA of the Federal Pegister notice
announcing the Interim Measures Program or within ninety days
after January 21, l9 l (the date of filing the Joint i otion
for Further Stay of tne Issuance of the Mandate), whichever is
later.
I. Definitions :
The following definitions apply to this document. The
definitions which are part of EPA’s PCB Ban Rule, 40 C.F.R. Part
761, also apply to this document unless they are inconsistent
with the definitiori 1 s set forth below.
A. “leak” i’iearis an ’ instance in which a PCB rnit
has any PCBs on any portion of its external surface.
B. “ moderate leak ” i eans any leak which results in
any cuantity of PCPs running off or about to r n off the external
surface of the PC Cnit.
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C. 1 PC3 Dnit ” means any PCB Transformer or PC3—
Contaminated Transformer in use or stored for reuse.
D. “ posinc an ex osure risk to food and feed pro—
ducts ” means any potential. exposure of flood arid feed products
to PCBs as defined below. PC8 Units used by federally inspected
meat, poultry product, arid eg product establishments, as well as
facilities manufacturing, processing, packaging or holding human
food or animal feed, but excluding retail establishments such as
grocery stores and restaurants, are considered to pose an expo-
sure risk to food and feed ‘ roducts, unless the PC! Unit is iii
a location such that a disch rge of the dielectric fluid cannot
contaminate the food and feed products or pro esses.
E. “ servicing ” means repairing and cleaning or re-
placing the PC3 Unit to eliminate the source of the leak. C.lea iing
of the PC! Unit means removing any unsolidified dielectric fruid
on its external surface.
F. •“visual inspection ” means to investigate for any
leak of dielectric fluid on or around the PC3 tlni.t. A visual in-
spection should not require an electrical shutdown of the PC!
Unit being inspected. The extent of the visual. inspection will
depend on the physical constraints of each PC! Unit installa-
tion.
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II. The following procedures must be followed with respect
to all PCB Units OSLng an exposure ris to food and feed
products :
A user of a PCS Unit posing an exposure risk to food
and feed products shall notify the owner of the PCB Unit that
the Unit poses an exposure risk to food and feed products. If
the user fails to notify the owner, the user is responsible for
the inspection, recordkeeping, reporting and servicing of the
PCB Unit as set forth below.
The owner of a PC3 Unit posing an exposure risk to
1/
food and feed products shall perforn the following activities:
A. A visual inspection of each PCB Unit posing an ex-
posure risk to food and feed products shall be performed at least
once every week.
B. All leaks shall be recorded. Al). moderate leaks.
shall be reported to the appropriate EPA regional office within
five (5) business days from the date the leak is observed. If a
2C3 Unit is found to have a moderate leak, servicing is required
1/ If the owner of the PCB Unit is not the owner of the food
and feed establishment, the owner of the PCB Unit shall
have no obligation to perform the inspections required in
this section, until the owner is notified by the establish-
ment that the establishment is a food and feed facility or
until the owner of the PCB Unit has other : now1edge that
the establishment is a food and feed facility. To inform
food and feed establishments of the necessity of notifying
owners of PCB Units used at their establishments utilities
undertake to mail to their commercial and industrial cus-
tomers an annou e. ient requesting food and feed establish—
tne its to contact the utility or other owner of the C3
Un i
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and must commence within two (2) business days from the date
the leak is observed.
C. Records, containing inspection/servicing history,
with respect to all KB Units posing an exposure risk to food
and feed products shall be maintained for a period of three
years and shall be made available for inspection, upon request,
by EPA. Such records shall contain the following information
for each KB Unit:
(1) its location;
(2) the date of each visual inspection made of
the Unit, together with an identification of
the person performing the inspection;
(3) all, leaks observed in the Unit, together with
the date observed, and whether the leak was a
moderate leak; and
(4) a description of all servicing performed
on the Unit commencing as of the date the
Unit is first inspected pursuant to these
Interim Measures, together with the date
of such servicing.
C. Reports to EPA regional offices shall be in writ-
ing and shall contain the location of the PCB Jnit involved, the
date the moderate leak was observed, an estimate of the extent
of the leak and a de cription of the servicing performed,
including the date( s) of the servicing performed.
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til. The following orocedures must be followed with resDect
to all PCB Transformers n use or stored for reuse
posing no exDosure r].sk co food and feed Droducts (all
PCS Transformers no.t covered Lri secti.on II) :
Owners of PCB Transformers in use or stored for reuse
posing no exposure risk to food and feed facilities shall per-
form the following activities:
A. A visual inspection of each PCB Transformer posing
rio exposure risk to food and feed products shall be performed at
least once every three months.
B. All leaks shall be recorded. If a PCB Transformer
is found to have a moderate leak, servicing is required arid
must commence within two (2) business days from the date the
leak is observed.
C. Records, containing inspection/servicing histcry
with respect to all PCB Transfo.rmers in use or stored for reuse
shall be maintained for a period of three years and shall
be made available for inspection, upon request, by 2A. Such
records shall contain the following information for each PCB
Transformer:
(1) its location;
(2) the date of each visual inspection made of
the PC3 Transformer, together with an identi-
fication of the person performing the inspec-
tion;
(3) all leaks observed in the PC3 Transformer, to.-
gether with the date observed, and whether the
leak is a moderate leak; and
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(4) a description of all servicing performed
on the PCB Transformer commencing as of the
date the PCB Transformer is first inspected
pursuant to these Interim Measures, together
with the date of such servicing.
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Untied Staies Pesticioes and
Environmentai Protection Toxic Substances
Agency Erilorcement Division
EPA Enforcement Facts
and Strategy
FOB
Interim Measures Program
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Enforcement Facts and Strategy
Polychiorinated Biphenyls (PCBs)
Interim Measures Program
August, 1981
Contents
Page
Background. . . . . . . . . . . . . . . . . . •1 • • • • • • • • • . . •... . . . . . . . , . . . . . . . 1
Regulated Community .................................. 2
Summary of Requirements..................................... 2
V i 01 at i on S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Enforcement Objectives...................................... 5
,. 1•
.omp 1ance on1 oring.......................................
Interagency Cooperation..................................... 10
Vol untary Compi iance/Awareness Effort. ......... . . . . . . . •1 11
All ocati on of Responsi bili ties. . . . . . . . . . . . . . . . . . . . 12
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ac Kç ro unu
In 1979, the Environmental Defense Fund brought a lawsuit in the
U.S. Court of Appeals for the District of Columbia against
the U.S. Environmental Protection Agency (EPA) regarding the
PCB Ban Rule (40 CFR 761 ). The Court’s decision on October
30, 1980, set aside the portion of the PCB rule which classifies
the use of intact, non—leaking, PCB—containing transformers,
capacitors, and electromagnets as uses of PCBs In a. “totally
enclosed manner.” Since use of PCBs in other than a totally
enclosed manner is unlawful under Section 6(e) of the Toxic
Substances Control Act (TSCA) without an authorization from
the Administrator, the Court ruling makes continued use of
PCB—containing transformers, capacitors, and electromagnets
ill egal
Because the effect of this decision would have seriously disrupted
the distribution of electricity in this country, representatives
of the electric utilities, chemical industry, Environmental -
Defense Fund, and EPA worked together to develop an Interim
Measures Program. They petitioned the Court to stay its
mandate for those who comply with the Interim Measures Program
until the Agency is able to develop appropriate amendments to the
PCB regulation. The Court granted the stay on February 12, 1981
1eavir g provisions of the PCB rule that the Court’s decision
had set aside still in effect for those who comply with the
Interinr Measures Program.
Under the Interim Measures Program, owners of certain PCB units
must visually inspect them, record all leaks, and begin repair
of any moderate leaks within two days of discovery. PCB and
PCB—contamiriated transformers posing an exposure risk to food
and feed products must be visually inspected by their owners
at least once a week, and any moderate leaks found must be
reported to EPA within five days of discovery. All other
PCB transformers must be visuafly inspected by their owners
at least once every three months. The Program became effective
on May 11, 1981.
A notice detailing the background and requirements of the
Interim Measures Program was published In the Federal Register
on March 10,1981 . A notice clarifying certain aspects of the
Program was published in the May 20, 1981 Federal Register.
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Regulated Community
There are an estimated 140,000 PCB transformers still in
service or in storage for reuse. Approximately one—third of
these transformers are used by the electric utility industry;
the otner two—thirds are distributed among general industrial
facilities and commercial buildings. Leaks from these trans-
formers may result in PCB contamination of the environment.
The estimated 3,600 PCB transformers and larger number of
PCB—contaminated transformers in use in food and feed products
facilities are particularly sensitive because leaks could
result in widespread human or animal exposure.
All owners of PCB transformers and PCS—contaminated transformers
which pose an exposure risk to food or feed products and owners
of all other PCB transformers are subject to the requirements
of the Interim Measures Program.
Summary of Requirements
Definitions
The definitions in the PCB Ban Rule (40 CFR Part 761) apply-to
the Interim Measures Program unless they are inconsistent with
the definitions set forth below.
“Leak” means any instance in which a PCB unit has any quantity of
PCBs on any portion of its external surface.
“ Moderate leak ” means any leak which results in any quantity of
PCBs ruilning off or about to run off the external surface of the
PCB unit.
“ PCB unit ” means any PCB transformer or PCB—contaminated transformer
in use or in storage for reuse.
“ PCB unit posing an exposure risk to food and feed products ” means
a PCB unit used by a federally inspected meat, poultry product, or
egg product establishment, or in a facility manufacturing,
processing, packaging, or holding human food or animal feed,
unless the PCB unit is in a location where a discharge of the
dielectric fluid cannot contaminate the food and feed products
or processes. The definition excludes retail establishments such
as grocery stores and restaurants.
“ Servicing ” means repairing and cleaning or replacing the PCB unit
to eliminate the source of the leak. Cleaning of the PCB unit
means removing any unsolidified dielectric fluid on its external
surface.
- “ Visual inspection ” means to investigate for a leak of dielectric
luid on or around the PCB unit. Such Inspection should not require
.hutdown of the unit being inspected, and the extent of the inspection
will depend on the physical constraints of each PCB unit installatio-
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—3—
PCB Units in Food and Feed Facilities
For.PCB units (that is, PCB transformers or PCB—contaminated
:ransformers) posing an exposure risk to food and feed products,
the owner* must:
o Perform a visual inspection of each PCB unit at least
once a week.
o Record all leaks.
o Begin servicing moderate leaks within two business days
of observation of the leak.
o Report in writing all moderate leaks to the appropriate
EPA Regional office. Reports must contain:
—— The location of the moderate leak;
-- The date the leak was observed;
-— An estimate of the extent of the leak; and
—— A description of the servicing performed, including dates.
o Maintain records containing inspection/servicing history for
a period of three years, and make them available, uporT request,
to EPA. Records must contain the following information for
each PCB item:
—— Its location;
—— The date of each inspection, including an identification
of the person who performed it;
—— All leaks observed, the dates observed, and whether they
were moderate leaks; and
-— A description of all servicing of the unit undertaken
since the date of the first inspection under the Interim
Measures Program, including dates of the servicing.
*NOTE: The user of a PCB unit posing an exposure risk to food or
feed products must notify the owner of the unit that it
is in a food and feed facility, and is responsible
for compliance with the Interim Measures Program
until he so notifies.
If the user fails to notify, the owner (e.g., the
utility company) is not obligated to perform the
compliance actiyities until the firm has other
knowledge that the user’s establishment is a food
or feed facility with a PCB unit posing an exposure
risk to food or feed products.
If a user informs the owner that a PCB unit may pose
an exposure risk to food or feed products, the owner
must make a determination, by inspection or other
inquiry, whether the unit poses an exposure risk and
is consequently subject to the weekly inspection
requirement. Any PCB transformer (above 500 ppm PCBs)
which is determined not to pose an exposure risk to food
or feed p’roducts is subject to the quarterly inspection
requirements for all PCB transformers.
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-4-
All Other PCB Transformers in Use or Storage for Reuse
Owners of all other PCB transformers in use or storage for reuse
(those which do not pose an exposure risk to food or feed products)
must meet the inspection, servicing, and recordkeeping requirements
set out above, but only with regard to PCB transformers.
The visual inspections of PCB transformers In this category
must be performed at least once every three months instead
of at least once a week. No reporting of moderate leaks to
EPA Regional offices is required.
Violations
As indicated earlier, the Court’s decision invalidated that
portion of EPA’s regulations which characterized transformers,
capacitors, and electromagnets as “totally enclosed.” Since these
uses of PCBs are not authorized, they would now be a violation
of Secti, r 6(e) of the Toxic Substances Control Act if the Court
had not issued a stay of its decision. However, the Court stayed
its decision only for those people who institute the Interim
Measures Program. Accordingly, any person who does not comply
with all of the requirements of the Interim Measures Program is
using PCBs in violation of the prohibition in Section 5(e) of
TSCA. The following is a list of the various ways in which the
-requirements of the Interim Measures Program can be violated.
o Fail ire to perform visual inspections . Since performing visual
inspections is a prerequisite to performing other Program re-
quirements, a company which fails to inspect some or all of its
subject PCB units will also be in violation of the other require-
ments for the uninspected units. PC3 and PCB—contaminated
transformers are subject to the weekly inspection requirements
if an exposure risk is posed to food or feed; all other
PCB transformers are subject to the quarterly inspection
requirements regardless of where the transformers are located.
Variations of this violation category include:
o Performing no visual inspections.
o Performing visual inspections on only some of the
subject PCB units.
o Performing visual inspections at greater than the
Intervals specified.
o Failure to record all leaks . Included in this violation
category are:
o Not recording any leaks.
o Recording only moderate leaks.
o Not noting in records whether leaks are moderate.
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o Failure to initiate servicing of moderate leaks within two
business days of discovery . This violation category includes:
o Not servicing moderate leaks at all.
o Servicing only some moderate leaks.
o Not adequately repairing the source of the mocerate
leak or cleaning the external surface of the PCB unit.
o Initiating servicing of moderate leaks later than two
business days of discovery.
o Failure to report moderate leaks to EPA within five business
days of aiscovery (PCB units posing an exposure risk to food or
feed products only) . Variations of this violation category include:
o Not reporting any moderate leaks.
o Not reporting some moderate leaks.
o Reporting moderate leaks to EPA later than five business
days of discovery.
o Providing incomplete Information in the report to EPA.
o Failure to maintain required records . This category includes:
o Maintaining iio records.
o Maintaining incomplete records.
o Not initiating maintenance of records on the effective
date of the Interim Measures Program.
o Falsification of reports or records .
EnforCement Objectives
As in the overall PCB enforcement program, the key objective of
the strategy for enforcement of the Interim Measures Program is to
ensure the proper disposal of PCB5 and thereby prevent the risk
of environmental contamination by PCBs.
Since moderate leaks, that is, those which are running off or about
to run off the external surface of the PCB item, constitute improper
disposal and could result in environmental contamination, EPA is
especially concerned that such leaks be detected and repaired in
a timely manner. The inspection and servicing requirements of
the Interim Measures Program are designed to ensure that this
occurs, while the reporting and recordkeeping requirements allow
EPA to monitor compliance as well as gather additional information
on the frequency and seriousness of PCB leaks.
Because the program was developed as a result of a court case and
not as a result of a rulemaking activity, the first phase of
implementation will involve wide—reaching efforts to inform the
regulated community of the requirements. To augment publication
of the Federal Register notice, efforts will be made to notify
various Industry categories through appropriate trade association
and other communication channels.
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Compliance monitoring will be directed initially at the utility
and food and feed industries. The utility industry was selected
because it controls approximately one—third of the PCB
transformers, was a party to the development of the Interim
Measures Program, and can be expected to be aware of the
Program’s requirements. The food and feed industry was selected
because of the potential for human exposure to PCB5 that could
occur from leaks or spills which result in contamination of food
or feed. Since the utilities own a large percentage of the
transformers used by food and feed facilities under rental
agreements with the utility companies, the compliance monitoring
effort directed at utilities will extend to many food and
feed facilities as well. Additional compliance monitoring
will be directed toward food and feed establishments specifically.
In addition to the special compliance monitoring program for
utilities and food and feed facilities, EPA will incorporate
determination of compliance with the Interim Measures Program
into its regular inspection pro rarn for enforcement of the
PCB rule. These inspections at conducted under the neutral
administrative inspection scheme developed for PCB rule
compliance monitoring activities In the overall PCB enforcement
strategy.
In some instances, reports or records of moderate leaks referred
to the Agency under the Interim Measures Program requirements
may indicate the potential for significant environmental contami-
nation. Consequently, each moderate leak report will be evaluated
by the Agency to determine if any followup response is needed to
ensure adequate cleanup of the affected area. When food and feed
establishments are involved, EPA n Ih notify other appropriate
Federal and State agencies to ensure that no contaminated products
are entered into commerce.
As mentioned previously, moderate leaks of PCBs constitute improper
disposal as defined in the PCB rule 1 and must be cleaned up in
accordance with the requirements of that rule. The fact that
a moderate leak has been reported to the Agency and the source
of the leak repaired does not remove this liability, and
failure to properly clean up is subject to the same penalties,
defined in the overall PCB penalty policy, as would any other
PCB spill. Penalties to be assessed for failure to comply
with the inspection, repair, reporting, and recordkeeping
requirements of the Interim Measures Program are discussed
in a supplement to the PCB penalty policy.
Comoliance Monitoring
tnpliance monitoring for the Interim Measures Program is divided
ito two parts: a routine compliance monitoring program consisting
Thf inspections conducted across the range of industrial categories
subject to the requirements, and a records review effort directed
specifically at the,-utihity and food and feed industries.
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—7—
Routine Compliance Monitoring
Routine on—site inspections for compliance with the PCB rule will
continue in accordance with the neutral administrative inspection
scheme developed by the Regions under the overall PCB enforcement
strategy which identifies the major industrial categories controlling
the vast majority of PCB equipment. The routine inspections will
incorporate record checks to determine compliance with the Interim
Measures Program as an element of regular PCB rule inspection
procedures.
Utility companies and food and feed establishments have the highest
priority for compliance efforts under the Interim Measures Program.
However, many utility companies and food and feed establishments
have been inspected during the past two years to determine corn—
pliance with the PCB rule. Because of limited Agency resources
and the need to move forward with inspections in other segments
of tne regulated community, on-site re—inspections will not be
scheduled specifically to determine compliance with the Interim
Measures Program. Such companies may be re—inspected, however,
if they are selected for on-site inspection through the Region’s
neutral administrative inspection scheme or for followup inspection
due to previous violations. In such instances, compliance with
the Interim Measures Program will be determined as part of the
routine PCB rule inspection.
Records Review
In addition to the routine compliance monitoring effort_..for all
industry categories subject to PCB rule requirements, a special
effort- will be directed at utilities and food and feed facilities
because of the high priority given to ensuring compliance in
these industries. This effort will consist of mailing letters
requesting submission of records required by the Interim
Measures Program for review in the Regional office. On—site
inspections may be scheduled as a followup to this review.
o Utility Facilities
Each EPA Regional office should develop a formula for random
selection of approximately five percent of utility company
facilities in the Region. Then, letters should be sent to
the parent utility companies, by certified mail, requesting
submission of the records required under the Interim Measures
Program as well as a copy of the annual document required
by the PCB rule.
The request should specify the facility(ies) for which records
are sought, and the time period to be covered by the records
submitted. By asking for different time periods at each facility,
the possibility of falsification of records is reduced while
reducing the total number of records submitted.
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—8-.
If a utility company falls to respond by the specified date,
a subpoena will be issued to secure the records. If the
company still does not produce the records, a further
investigation will be initiated to determine if the company
has conducted the required inspections and servicing.
The facilities selected for records review should be divided
into batches to receive mailings at different times during
the year. The first series of letters to utility companies
requesting records should not be mailed until mid—November,
1981 , to allow sufficient time for at least two company—conducted
inspections of each PCB transformer. (The first quarterly
inspection should have been completed by August 10, 1981.)
o Food and Feed Facilities
In many instances, transformers located in food and feed
facilities are actually owned by the local utility company.
It is the owner who is responsible for compliance
with the Interim Measures Program. Consequer: y, obtaining
records for review requires a two—step process: first,
identifying the owner of any PCB units in a food and
feed facility subject to the requirements; ar?d second,
requesting the desired records.
Using lists of facilities provided by the Food and Drug
Administration and the Department of Agriculture’s Food
Safety and Quality Service, the Region should randomly
select five percent of the food and feed establishments
i-n the Region where PCB units may be located.
If the Region has knowledge that a selected food or feed
facility owns its own transformers, a letter should be
sent requesting the annual document and required
records covering approximately one month of weekly
inspections. If there is no response, the procedures
described for utility companies should be followed.
If the Region is unsure of the ownership of transformers
at a selected food or feed facility, the letter to the
facility should request submission of records and annual
documents by those facilities owning their own transformers
or the identity of the owner (e.g., the utility company)
for those who do not. When the response is an identification
of the owner, the Region should send a second letter to
the owner requesting submission of the records and annual
document.
The food and feed facilities selected for records review
should be divided into batches to receive mailings at
different times during the year. The first letters requesting
annual documents and records from food and feed facilities
can be sent as soon as the Region is ready to do so
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—9-
since the weekly inspection requirement has been In
effect for several months. (The first weekly inspection should
have been compi eted by May 18, 1981 .)
It should be noted that a food and feed facility may respond
that it does not have any transformers subject to the re-
quirements. Only PCB and PCB—contamlnated transformers
posing an exposure risk to food or feed products must
be inspected weekly. All other PCB transformers (but
not PCB—contaminated) at food and feed establishments
must be Inspected quarterly, regardless of where the
transformers are located.
o Conducting the Records Review
The records submitted in response to the mailing will be
reviewed, and some companies may be selected from this
group for further investigation. In addition to evaluating
records for completeness, dates of visual inspections and
servicing will be checked to see if they were performed
within the required timeframes. The number of’transformers
in the annual document will be checked against the number
of transformers for which there are records of inspections.
Records from food and feed establishments will be checked
for discrepancies between the information in the records
regarding moderate leaks and what was (or was not)
reported to EPA as required. If any company’s
records show an unusually high or low incidence of leaks or
apparent inaccuracies oc.—other deficiencies, the company may
be selected for further investigation, possibly including
an on—site inspection.
o Evaluation
To assist in measuring the effectiveness of the Interim
Measures Program and the enforcement strategy, Regions
should provide to the Pesticides and Toxic Substances
Enforcement Division summaries based on their review of
records submitted by the utility companies.
The summarieswill show response rate to the requests for
records, rate of compliance with Individual requirements
of the Program, and an analysis of the frequency of moderate
leaks. Information from on—site Inspections may also be
I nd uded.
A format for preparing the summaries will be provided to
the Regions by the Pesticides and Toxic Substances Enforce-
ment Division. The summaries should be submitted at the end
of the third quarter of FY 1982.
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—in-
Interagency Cooperation
The Food and Drug Administration (FDA) and the U.S. Department
of Agriculture’s Food Safety and Ouality Service (FSOS) also
have regulatory jurisdiction at food and feed establishments
and independently carry out compliance monitoring efforts
under their own programs. Because potential PCB contamination
of food and feed products is also of interest to these agencies,
the Regions are encouraged to develop a cooperative program
to foster compliance with the Interim Measures Program.
Following is a suggested framework for such a cooperative
effort which may be adapted as appropriate, depending upon
Regional differences in degree of cooperation at the
operational level.
o Interagency Staff Briefing . Appropriate management and
inspection personnel of the other agencies should be briefed
about the PCB Interim Measures Program. Copies of this
enforcement strategy and the Fact Sheet that is developed
(see Voluntary Compliance, below) can be used to explain
the Program.
o Moderate Leak Reoorts . EPA will be receiving reports of moderate
PCB leaks at food and feed facilities. The Regions should set
up mechanism for ensuring that all interested agencies are
notified of the situation; this may include State agencies, if
appropriate. This mechanism should also be used to coordinate
the response to a moderate leak report to determine which, if
any, agency(ies) will conduct an on—site inspection of the
facil ity.
o Facility List Sharing . FDA and FSQS have lists of facilities
subject to their regulations. The EPA Region should work
through their interagency contacts to obtain lists for use
in selecting food and feed facilities for records review and
on—site inspections.
o Referral of Information . Food quality agency inspectors may
observe leaks or otner indications of noncompliance while
conducting their routine inspections. They are encouraged
to refer such information to EPA. To aid in this effort,
EPA Regions may want to develop a screening tool that can
be used by other agency inspection personnel to help identify
potential noncompliance or other problems with regard to
PCBs in food and feed facilities. EPA may also supply
copies of the Fact Sheet for distribution by the inspectors
when they are visiting food and feed facilities.
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—Il —
While the exact nature and extent of interagency cooperation
should be determined at the Regional level , EPA Headquarters
will assist in fostering Such cooperation as necessary.
Headquarters will make copies of educational materials
available for use by the Regions and will provide assistance
in the development of referral inspection guidance.
Voluntary Comoli ance/Awareness Effort
A notice regarding the Interim Measures Program was published
in the Federal Register on March 10, 1981; a clarification
was published on May 20, 1981. In addition, the utility industry
has itself, in response to the Court mandate, undertaken an
educational effort to inform its member companies about the
Program’s requirements,
To augment these activities, the Pesticides and Toxic Substances
Enforcement Division is working with the Industry As istance
Office of the Office of Toxic Substances to disseminate infor—
mation about the Program to other industry and economic sectors
affected by its requirements. This effort includes contacting
industry representatives personally, making copies of the
Federal Register notices available for mailing to trade association
members, developing and distributing a Fact Sheet for food and
feed facilities, and providing draft articles describing the
Program and enforcement strategy to industry publications.
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—12-
P1SED will provide printed
m erials for use in briefing
other agency staff. (PSB)
PTSED will provide assistance
ana guidance material, as needed,
to roster interagency cooperation.
(CMB)
3. Compliance Monitoring
3a. Records Review
PTSED will provide guidance on
developing a formula for
selecting facilities. (CMB)
PTSED will provide guidance and
‘ample letters for use in
equesting records. (CDLB)
Regions will brief other agency
personnel on the !nterimMeasures
Program.
Regions will obtain lists of
food and feed facilities
from FflA and FS( S.
Regions will set up a mechanisri
for notifying food quality
agencies about moderate leaks
and determining which, if any,
agency(ies) will conduct an
on—site inspection.
Regions will incporporate the
PCB Interim Measures Program
into the interagency Referral
Inspection Program as appropriate.
3. Compliance Monitoring
3a. Records Review
Regions will prepare a randomly
selected mailing list covering
approximately 5 percent of utility
and food and feed facilities.
Regions will mail records request
letters to selected utilities
and food and feed facilities.
iiocation c eS OnS’.D1l1tieS
?leaaquarters (PTSED)
Regions
1 . Awareness Effort
1 . Awareness Effort
PISED will work with Office of
inaustry Assistance (OTS) to
implement a strategy for
informing the regulated
community of Interim Measures
Program requirements. (PSB)
Materials will be made available
to the Regions. (PSB)
2. Interagency Cooperation
Regions may perform additional
educational activities.
2. Interagency Cooperation
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—13—
Headquarters (PTSEDY
PTSED will provide policy
assistance if needed for the
issuance of subpoenas. (PSB)
PTSED will provide guidance
for the review of records
submissions. (CMB)
PTSED will provide guidance on
documentation required for
proof of violations. (CDLB)
PTSED will provide a supplemental
PCB penalty policy and levels
of action guidance for the
Interim Measures Program. (PSB)
PTSED will assist Regions in
determining appropriate enforce-
ment action and penalties, as
needed, and concur in
complaints. (CDLB)
Regions
Regions will Issue subpoenas to
companies not complying with the
request letters.
Regions will review submitted
records and may select some
companies with incomplete records,
unusually high or low incidence
of leaks, or indicators of
potential environmental contami-
nation problems for on—site
Inspection. Such Inspections may
be complete PCB rule inspections.
3b. Reports of Moderate Leaks
Regions will designate an
individual to receive reports of
moderate leaks from food and feed
facilities.
Regions will evaluate all reports
to determine If an Agency response
is needed. Response can range from
a followup telephone call, to
alerting food quality agencies, to
an on—site Inspection.
Regions will review records sub-
mitted by utility companies and
inspection reports to determine
violations.
Regions will prepare notices of
noncompliance or complaints in
accordance with the supplemental
PCB penalty policy and guidance.
Regions will submit complaints
for PISED concurrence.
3b. Reoorts of Moderate Leaks
3c. Routine Compliance Monitoring
3c. Routine Compliance Monitoring
PTSED will prepare inspection
procedures for compliance
monitoring for the Interim
Measures Program. (CMB)
Regions will include procedures
to determine compliance with the
Interim Measures Program in their
routine PCB rule inspections.
4. Case Development
4. Case Development
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—14 -
Headquarters (PTSED) Regions
5. Summary of Compliance 5. Summary of Compliance
PTSED will provide guidance on
the preparation of summaries of
compliance with elements of the
Interim Measures Program. (PSB)
Regions will prepare summaries
of responses to the records
requests and compliance data,
and forward to PISED. Infor-
mation from routine compliance
monitoring may be included.
The first summaries should be
submitted at the end of the third
quarter of FY 1982.
PISED will prepare a natHnal
summary. (CDLB)
PTSED will modify the enforcement
strategy and—procedures as
ieeded. (PSB)
PTSED——Pesticides and Toxic Substances Enforcement Division
PSB——Poiicy and Strategy Branch
CMB-—Compliance Monitoring Branch
CDLB——Case Devel opment anr Legal Branch
OTS——Office of ToxVc Substances
FDA——Food and Drug Administration
FSQS——Food Safety and Quality Service
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v UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
i f WASHINGTON. O.C. 20460
‘ ‘i.u”
SEP I 4 l9 ’
O.F ,cI or
PISTICIOLS ANO TO*IC SUeITANCCI
MEMORMOUI
SUBJECT: Civil Penalty Cases Involving Use of PCBs In Hydraulic S’ystems
TO: Enforcement-Division Directors
Air and Hazardous Materials Division Directors
Surveillance and Analysis Division Directors
Several administrative PCB penalty cases submitted by Region V for
Headquarters review have raised Issues which need clarification regarding
the use authorization for PCBs In hydraulic systems. This memorandum will
address two basic questions: 1) What evidence Is necessary in order to
charge a company with failure to test Its hydraulic systems, and 2) Under
what circumstances are charges for Improper disposal of PCB hydraulic
fluid appropriate.
Failure to Test
Under §761.31(e) (1) of the PCB Regulation, each person who owns a
hydraulic system that ever contained PCBs must test for the concentration
of PCBs In the hydraulic fluid.1/ In the situation where samples of hydraulic
fluid analyzed by EPA show greater than 50 ppm PCBs and the company has
not tested its machine, there is clearly a violation for failure to test.
When the company has not tested its machine and samples show the PCB concen-
tration to be less than 50 ppm, however, additional evidence must be obtained
to show that the system ever contained PCBs. A charge for failure to test
should not be brought if the PCB concentration of the hydraulic system is
below 50 ppm unless there exists evidence such as the following:
- Company records show PCB purchases for the company’s hydraulic machines;
- Records’from Monsanto or another supplier Indicate PCBs were soldto
the company for Its hydraulic machines;
1/ The phrase “ever contained PCB5N Is Interpreted to mean ever contained
PCBs greater than 50 ppm in accordance with §761.1(b) —— “Unless It is other-
wise specifically provided, the tems PCB and PCBs are used in this rule
to refer to any chemical substances that contain SO ppm (on a dry weight
basis) or greater of PCBs. . .“
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—2—
- An oral statement was made by company representative(s) that PCB
fluid had been used in the hydraulic systems at one time; or
- Infonuatlon regarding the age, size, or type of the hydraulic machines
indicates that the systems had contained PCBs.
Disposal
Because hydraulic systems frequently leak, the issue of whether Improper
disposal of PCBs has occurred is often raised. After reviewing a nunter
of cases, it appears that this disposal Issue most often poses itself at
three different stages in the hydraulics operation —- 1) when PCBs have
leaked onto the floor from the hydraulic system; 2) when absorbent material
containing PCBs is found In trenches or sumps near the machines; and 3) when
PCB debris has been removed from the trenches or sumps. Each situation Is
discussed below:
A. When PCBs Have Leaked onto the Floor from the Hydraulic System
When oil (which has recently leaked out of the hydraulic system onto
the floor) Is found to be concentrated at greater than 50 ppm PCB, it can
be argued that Improper disposal has occurred. In a situation where the
company has failed to provide contairinent around the machine or has not
regularly cleaned the area, a charge for improper PCB disposal is appropri-
ate. However, because the use authorization for PCBs In hydraulic systems
acknowledges that the systems are other than totally enclosed, leaks should
not be considered 1 proper disposal if the company has taken reasonable
steps to contain or clean up the oil before EPA ’s inspection. Depending
on the type of PCB containnent, however, a storage charge may be appropriate.
B. When Absorbent Material Containing P Bs is Found in Trenches or Sumps
Near the Machines
In many hydraulics operations, oil which has leaked onto the floor
from the machines is cleaned up with absorbent material and washed into
trenches or sumps. Because this material is usually cleaned out of the
sumps on a periodic basis, debris which is found to be concentrated at
greater than 50 ppm would be considered stored for disposal In most instances.
Charges for failure to properly store and mark PCBs would therefore be-
appropriate In situations where there is evidence that the material in the
sump Is periodically collected and disposed of. In the event that the
sump drains into the sewer system, a disposal violation may exist if the
material in the sump contains PCBs at greater than 50 ppm, and the material
flowing out of the sump contains any detectable PCBs. This may be considered
improper disposal if it can reasonably be argued that the PCBs in the sump
are leaching into the liquid which is flowing out of the sump. In this case,
the liquid is considered a PCS since the concentration is less than 50 ppm
because of dilution [ see S761.1(b) 3.
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—3—
C. When PCB Debris Has Been Removed from the Trenches or Sumps
The question of whether Improper disposal of PCBs has occurred Is again
raised In situations where the company practice Is to collect PCB debris
fran the trenches or sumps to be discarded. If s ip1ed debris Is found to
contain greater than 50 ppm PCBs and is observed In a dumpster or containers
awaiting pick-up by a trash collector, a disposal charge Is warranted.
Without a sample, it would be difficult to determine the amount and con-
centration of PCB debris Involved In past disposal. In the latter situation,
bringing a disposal charge is discouraged. Although a charge for improper
d l sposal Is not recommended wI thout a sample, a charge for impro 3er storage
of the debris In the sump may be appropriate if a sample shows the sump to
contain greater than 50 ppm PCBs. If the volume and PCB concentration of
material In the sump Indicates that there may be a serious disposal problem,
a follow—up Inspection should be conducted In order to obtain more substantial
evidence of a disposal violation.
I hope that this discussion of testing and disposal has clarified some
of the issues raised In cases Involving hydraulic systems. If you have
further questions, please contact Marcie Kieban (8—755—7999) of my staff.
IY f
it11 , L2/Yvv#V
IC . Conroy(1T 1 Dt rector
Pesticides and ‘ oxtc Substances
Enforcement\Pjvi slon
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iIO Sr 4 ,
0 iL
MEMORANDUM
SUBJECT: Final Enforcement Re
and 13
FROM: John J. Neylan III, Dir
Policy and Grants Division
Office of Compliance Monitori
TO: Addressees
I
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
Attached is the final revised Enforcement Response Polcy
(ERP) for TSCA § 8, 12 and 13. The final ERP remains very similar
to the proposed ERP issued on March 27, 1987 with changes made in
three areas. Failure to maintain TSCA §8(c) records in a manner
that meets the standard required in the rule has been made a sig-
nificant, level 3, one—day violation ($10,000). The second change
made is the addition of a violation for failure under the TSCA
§8(a) Inventory Update Rule to keep records showing that the manu-
facturer is not subject to reporting under the rule (major, level
6, $2,000). The third change to the ERP is a modification in the
per day assessment for violations of TSCA §8(a) Chemical Specific
rules. The per day assessment Is now the i*e base penalty divided
by 360. The maximum penalty for failure to report is now $34,189,
while the maximum penalty for late reporting is $12,067.
This ERP supercedes the previous TSCA § 8, 12 and 13
ERP and Its two succeeding amendments. I would once again like
to thank the Regions for their comments and cooperation In formu-
lating this ERP, especially the Regional participants In the
workgroup. If you have any questions concerning this final ERPI
please contact David Stangel of my staff at (FTS) 382—7825.
A discussion of the comments is attached.
Attachments
MAY 15 1987
OFFICE OF
PESTICIDES AND TOXIC SUSSTANCCS
LO
f l
• U
r.
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Addressees
Charles Elkins (TS—792)
Frederick F. Stieh1 (LE-134A
Stanley Abramson (LE—132A
Ken Shiroishi (EN—342)
Phyllis Flaherty ‘I
John Martin
John J. Neylan III
Ralph Turpin
Mike Wood I’
Gerald Stubbs
Dexter Goldman
Michael Walker (LE—134P)
Margaret Rostker (TS—788)
Michael Stahl (TS-788)(Asbestos documents)
Jake Mackenzie
Western Regional Compliance Director
A. Charles Lincoln
Eastern Regional Compliance Director
Louis F. Gitto, Director
Air Management Division, Region I
Barbara Metzger, Director
Environmental Services Division, Region II
Stephen R. Wassersug, Director
Hazardous Waste Management Division, Region III
Winston A. Smith, Director
Air, Pesticides and Toxics Management Division, Region IV
William H. Sanders III, Director
Environmental Services Division, Region V
William B. Hathaway, Director
Air, Pesticides, ana Toxics Division, Region VI
William A. Spratlin, Director
Air and Toxics Division, Region VII
Irwin L. Dickstein, Director
Air and Toxics Division, Region VIII
Jeffrey Zelikson, Acting Director
Toxics and Waste Management Division, Region IX
Gary O’Neal, Director
Air and Toxics Division, Region X
Regional Pesticides and Toxic Substances Branch Chiefs
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RESPONSE TO COMMENTS
Comment:
The penalties for TSCA §8(a) Chemical Specific reporting are
too high and should be assessed as a one—day penalty in the same
way that Inventory violations are handled,
Response:
The Office of Compi lance Monitoring and the Office of Toxic
Substances feel very strongly that penalties for TSCA §8(a)
CAIR and PAIR violations be higher than those for TSCA §8 Inventory
violations. In most cases, the Agency is asking for the informa-
tion under very strict statutory or court imposed deadlines and
the information is used to determine how the Agency will regulate
a chemical substance. The failure to report data In a timely man-
ner could seriously impair the decision to regulate a chemical
substance. We are, however, sensitive to the Region’s concerns
regarding the amount of the penalties. The ERP, therefore, has
been amended to reduce the amount of the per day penalty by di-
viding the base penalty by 360 instead of 180. This would re-
suit in a maximum penalty for failure to report violations of
$34,189, with $12,067 being the maximum assessed for late report-
ing. Both OTS and OCFI feel that while the penalties are higher
than those in the previous ERP, they are appropriate and shall
renain per day violations.
Comment:
The TSCA §8(a) Inventory Update penalties are too high con-
sidering that many of the violators will probably have multiple
violations, due to ignorance of the regulations.
Response:
While we agree that there may be Instances where a manufac-
turer is ignorant of the regulations, these Instances should not
dictate the penalty structure. The Inventory Update Rule is con-
structed in such a way that most small manufacturers (the group
most likely to be ignorant of the rule) are exempt from reporting.
In the event that a manufacturer fails to report on a large num-
ber of substances, the size of the business may mitigate the pen-
alty or the company could undertake other activities to mitigate
the penalty. If a large manufacturer fails to report on a large
number of substances, a substantial harm may have occurred to the
Agency’s efforts to characterize exposure and the penalties would
be appropriate.
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—2—
Comment:
The penalty policy is inconsistent in that a failure to re-
cord TSCA §8(c) allegations at all is categorized as a significant,
level 1 violation ($17,000) while a company that does keep allega-
tions but fails to keep them in the manner prescribed Is assessed
a major, level 2 violation ($20,000).
Response:
We agree that this situation is inequitable. The ERP has
been amended so that a failure to maintain TSCA §8(c) records.
in a manner that meets the standard required in the rule would
be a significant, level 3, one—day violation ($10,000). There
may be instances of a failure to maintain records or reports in
a manner that meets the standard required in other rules so the
violation will be reflected as both a level 2 and a level 3 vio-
lation. The ERP distinguishes between TSCA §8(c) records and
other records.
Comment
The ERP should incorporate some method of employing gross
market share/volume categories when determining penalties.
Response:
The workgroup has discussed a number of methods of factoring
market share or volume into the penalty calculations and has not
been able to develop a workable system to Incorporate these para-
meters into hazard assessment. Basically, the workgroup does not
believe that harm can be related to market share. Other problems
with such an approach are accurately determining market share,
dealing with those chemicals where the Agency is concerned with
very small amounts of a substance, and the potential for divulging
confidential business information.
Comment:
The current system of referring TSCA §13 cases to the Region
where the importer is located rather than allowing the Region where
the entry, and subsequent violation, occurred to take the case
is inequitable.
Response:
0CM agrees that Regions ,here the majority of importation
occurs bear a much greater resource burden without receiving pro-
per recognition for the resources expended. We are relu ctant to
once again amend the SPMS reporting system to include information
on referrals to other Regions. We propose to Include this infor-
mation on the PC Tracking System and have these referrals be re-
flected in workload modeling.
-------
Comment:
Regions should charge brokers with violations of TSCA §13 as
a means of acheiving compliance with the import regulations,
Response:
This office is deeply concerned with the practice of bringing
actions against a broker as a means of reducing the number of TSCA
§13 violations. The regulations at 40 CFR 707.20 require the Im-
porter to certify compliance with TSCA for all chemical substances
imported, The importer is clearly the responsible party rega d—
less of the type of contractual arrangement the Importer may have
with the broker. It is the responsibility of the importer to do
business with responsible brokers. While we agree that brokers
are responsible for many of the violations that occur and a tech-
nical assistance program would be of great benefit to educate the
brokers, the importers are ultimately responsible for compliance
with TSCA notwithstanding the actions of their agents. An importer
may wish to recover damages from a broker after the Agency has
concluded its civil action, but that Is a matter for which the
Agency has no concern. National policy requires that clvii ac-
tions be directed to the importer of record. Questions have been
raised as to the legality of directing any type of enforcement
actions towards the broker which 0CM and OECM are attempting to
address. Regions may wish to consider an educational campaign
for those brokers who commit violations of ISCA §13, along with
an informal warning letter to the broker stating the violation.
Comment:
Headquarters should reconsider the policy of concurrence for
all cases settled under the new ERP, especially those taken under
TSCA §13.
Response:
This ERP was revised in part to answer the concerns of the
Regions that the penalties under the old ERP were unrealistically
high and based mainly on when EPA conducted an inspection rather
than the potential harm that could have occurred. We feel that
these concerns have largely been answered by this document.
While the penalties assessed under this ERP will generally be
less than those in the past, we are concerned that penalties may
be reduced as they were in the past. We feel that the differ-
ences between the penalty assessed and the penalty collected
should be much smaller under this ERP than in the past. We
are more concerned with penalties under TSCA §8, but feel it
would be beneficial to ,iionitor the penalties assessed for all
-------
violations under this ERP. We anticipate relaxation of con-
currence for TSCA §13 violations to be forthcoming after re-
viewing the actions taken under this ERP. However, given the
wide disparity in how the Regions administer actions under
TSCA § 8, 12 and 13 at this time, we feel that requiring con-
currence as a means of administering the new ERP is prudent.
Comment:
0CM should distribute drafts of ERPs to the Office’s of Re-
gional Counsel as well as the Regional program offices.
Response:
At the insistence of the Office of Enforcement and Compliance
Monitoring (OECM), drafts of ERP’s are directed to that office with
OECM being responsible for transmitting these documents to the ORG.
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MAY 15 1987
RECORDKEEPING AND REPORTING RULES
TSCA SECTIONS 8, 12 AND 13
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITORING
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE IJ.S. ENVIRONMENTAL PROTECTION AGENCY
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Reporting and Recordkeeping Rules Enforcement Response Policy
CONTENTS
Introduction
Summary of Requirements/Ru1es Covered. . . . . . . . . . 1
Determining the Level of Action
Notice of Noncompliance . . . . . . . . . . , • • • • • 3
Administrative Civil Penalty . . . . . . . . . . . . . . 3
Injunctive Action . • • . • • • • , • • • • , • • • • • 4
Criminal Sanc ions . . . . . • • . • • • • , • • • , • , 4
Multiple Remedies . . . . . . . . . . . . . . . . . . . 5
Assessing an Admfrifstrative PenaTty ——
Summary of the Penalty Policy . . . . . . . . . . . . . 6
Explanation of the Penal y Policy . . . . . . . . . . . 16
Appendix 1: Caps for Per Day Violations
Ajoendix 2: Examp’es —________
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INTRODUCTION
Section 8 of the Toxic Substances Control Act (TSCA) author-
izes EPA to require chemical manufacturers, importers and pro-
cessors to keep records and to report certain information. TSCA
§12 requires the submission to EPA of information about chemical
exports. The TSCA §13 rule requires the submission of certifica-
tion statements concerning Import shipments of chemical substances.
These reporting and recordkeeplng provisions have similar types
of requirements, and therefore, similar types of violations. For
this reason, this Enforcement Response Policy addresses all these
provisions as TSCA reporting and recordkeeplng requirements.
Failure to comply with the recordkeeping and or reporting
provisions of TSCA is a violation of TSCA § 15(3)(A) and 15(3)( 3)
and subject to the remedies In TSCA 16.
Summary of Requirements/Rules Covered
TSCA §8(a) Inventory - Required reporting durIng 1977 by persons
who manufactured and/or imported reportable chemicals. (At this
date, these violations are most likely failures to report or
falsified reports.) (40 CFR 710)
TSCA §8(a) Inventory Update — Requires reporting by persons who
manufacture or import chemical substances which are on the TSCA
Chemical Inventory in quantities greater than 10,000 lbs. at a
specific site. Small businesses and certain classes of chemicals
are excluded. (51 FR 21438, June 12, 1986, 40 CFR 710)
TSCA 8(a) Preliminary Assessment Information Reporting Rule
( PAIR) - kequires reportfng by persons who manufacture or im-
port listed chemicals in quantities greater than 1,100 lbs.
per site. Small businesses are excluded. (47 FR 26992,
June 22, 1982, 40 CFR 712)
TSCA 8(a) Asbestos Reporting - Required reporting by persons
who mined, manufactured, imported, or processed asbestos by
November 1, 1982. ExemptIons Included small businesses, dis-
tributors, and builders. (47 FR 33198, July 30, 1982, 40 CFR 763)
TSCA §8(a) Chemical Specific Rules
TSCA §8(a) P-TBBA, P-TBT, P-TBB - 40 CFR 704.33
TSCA §8(a) Chlorinated naphthalenes - 40 CFR 704.83
TSCA §8(a) Chlorinated terphenyl — 40 CFR 704.85
TSCA §8(a) Hexachloronorbornadiene — 40 CFR 704.142
TSCA §8(a) 4,4’-niethylenebis(2—chloroanllifle)(MBOCA) —
40 CFR 704.175
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TSCA §8(a) Polybrorninated biphenyls (PBBs) — 40 CFR 704.195*
TSCA §8(a) Tris (2,3-dibromopropyl) phosphate - 40 CFR 704,205*
* These rules have been “sunsetted” and replaced by SNUR’s ,
TSCA §8(c) Alleged Significant Adverse Reactions — Requires
persons who manufacture, import, process, or distribute chem-
ical substances or mixtures in commerce to keep files of alle-
gations of significant adverse reactions and provide this in-
formation to EPA upon request. Exemptions include persons
whose activities consist of mining or other solely extractive.
functions; processors who are not also manufacturers if none
of the processors’ sites are engaged In activities described
in SIC 28 or SIC 2911; and persons who are solely distributors
or retailers. (48 FR 38178, August 22, 1983, 40 CFR 717;
amended 50 FR 46766, November 13, 1985, 40 CFR 717)
TSCA 8(d) Health and Safety Studies Submission — Requires
persons who manufacture, import, process, or propose to manu-
facture, import, or process listed chemicals to submit lists or
copies of unpublished studies to EPA. (47 FR 38780, September
2, 1982, 40 CFR 716 amended September 15, 1986, 51 FR 32720)
TSCA §8(e) Substantial Risk Reporting — Requires persons who
manufacture, import, process, or distribute in commerce a chem-
i cal substance or mixture and who obtain “new” information which
reasonably supports the conclusion that such substance or mix-
ture presents a substantial risk of injury to health or the en-
vironment to report such information to EPA within 15 days.
(Policy Statement, 43 FR 11110, March 16, 1978)
TSCA §12 Exports - Requi res persons who export chemicals subject
o final and certain proposed rules and orders under sections
4, 5, 6 and 7 of TSCA to notify EPA of the country of destina-
tion the first time a chemical is shipped to that country during
a calender year. (45 FR 82844, December 16, 1980, 40 CFR
707.60)
TSCA §13 Imports — Requires persons who import chemical sub-
stances to certify that each shipment is in compliance with TSCA
or is not subject to TSCA. (48 FR 34734, August 1, 1983, 19 CFR
12.118 through 12.127 and 127.28 amended, and 40 CFR 707.20)
Future TSCA §8 Rules — This policy also covers all future
rules promulgated under TSCA §8 or amendments to the above
rul es.
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—3—
DETERMINING THE LEVEL OF ACTION
Enforcement alternatives include a notice of noncompliance,
a civil penalty, injunctive relief, criminal action, or some
combination of these actions.
Notice of Noncompliance
A notice of noncompliance (NON) Is appropriate where:
(1) the violation is a first-time vlo1ation of TSCA §‘ 12 or 13
where there are no other TSCA violations for the shipment or
(2) 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 NON’s are:
o Minor technical omissions, i.e., failure to supply
required nenc itical information (such as, the phone
number of a technical contact).
o Failure to use certified mail In making a notification
(as required by a rule);
o Report sent to incorrect address but correctly identified
as a TSCA 8(_) submission;
o Report sent to correct address but not identified as a
TSCA §8() submission;
Administratrve Civil Penalty
will be the appropriate
An administrative civil
penalty
response for most violations
of these
regulations.
Concurrence
Civil penalties are to be assessed according to this policy.
Regional enforcement personnel must obtain written concurrence
from the Office of Compliance Monitoring of the Office of Pesti-
cides and Toxic Substances prior to Initiating a civil adminis-
trative penalty for TSCA § 8, 12 and 13. Reductions for settle-
ment purposes require the concurrence of 0CM as well and must
be in accordance with the TSCA Penalty Policy and this ERP.
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-4 -
Each reduction must be justified in the Consent agreement and
final order and specific dollar amounts attributed to each re-
duction. Headquarters may relax concurrence requirements on
a Region by Region basis after the Regions have gained experi-
ence with actions under these rules and the ERP.
Injunctive Action
Injunctive action under ISCA may he appropriate in certain
circumstances. Although §17 of TSCA can be a very effective
tool in obtaining compliance, it Is also more resource inten-
sive than a civil penalty action. In addition, it has been
the Agencyss experience that a civil penalty action is usually
sufficient to obtain compliance. For these reasons, the Agency
believes that the use of TSCA §17 remedies generally should
be limited to those instances where a civil penalty action will
not result in sufficiently swift compliance to protect human
health or the environment. For example, injunctive action may
be used to require a company to maintain records where the atti-
tude of the violator indicates that this would not be done
otherwise or where there is a repeated history of failure to
keep records.
Criminal Sáictions
Criminal sanctions pursuant to TSCA 16(b) are the most
serious sanctions available for violations of the recordkeeping/
reporting rules. Accordingly, criminal sanctions may be sought
in situations that —— when measured by the nature of the conduct,
the compliance history of the subject(s) or the gravity of the
health or environmental consequences —— reflect the most serious
cases of misconduct.
Several factors distinguish criminal cases from administrative
or civil actions. First, criminal sanctions will ordinarily be
limited to cases in which the prohibited conduct is accompanied
by evidence of “guilty knowledge” or Intent on the part of the
prospective defendant(s). TSCA imposes criminal penalties only
for violations of the Act which are committed “knowingly or
wil iful ly”.
A second factor to consider is the nature and seriousness of
the offense. As a matter of resource allocation, EPA will inves-
tigate and refer only the most serious forms of misconduct. Of
primary importance to this assessment is the extent of environmental
contamination or human health hazard that resulted from, or was
threatened by, the prohibited conduct. Also of significance is
the impact, real or potential, on EPA’s regulatory functions.
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—5—
Third, the compliance history of the individual(s) or per-
son(s) for a potential criminal case is important. Criminal
sanctions become more appropriate as incidents of noncompliance
increase. While not a prerequisite, a history of noncompliance
will often indica ithe need for criminal sanctions to achieve
effective individual deterrence.
Multiple Remedies
There may be unusual instances where a particular situation
will present facts that suggest that more than one final action
should be taken. 0CM does not encourage the use of multiple re-
medies for the reasons discussed below. The purpose of this
Section is to outline when multiple remedies are appropriate.
Criminal Sanctions —__________________________________________________
Simultaneous civil and criminal enforcement proceedings are
legally permissible, United States V. Kordel , 397 U.S. 1, 11
(1970), and on occasion are clearly warranted. These cases
should be the exception rather than the rule. When parallel
proceedings are contemplated, please refer to the Office of En-
forcement and Compliance Monitoring guidance on parallel proceed-
ings (January 23, 1984).
Notice of Noncompliance
In general, a notice of noncompliance should not be used in
conjunction with any other final remedy. Where a particular
situation presents several violations, some of which would merit a
notice of noncompliance, while others would merit civil penalties,
no notice of noncompliance should be sent. Instead, an adminis-
trative penalty action should be initiated, pleading all viola-
tions, with no penalties for minor infractions which would other-
wise warrant an NON.
Civil Administrative Penalties and Specific Enforcement -—
The criteria outlined in this section anticipate that civil
penalties and specific enforcement (injunctive action) will be
used sequentially. There may, however, be Instances where the
concurrent use of these remedies is appropriate. If the Region
deems this to be appropriate in any case, it should consult with
0CM and OECM before bringing either action.
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ASSESSING A CIVIL ADMINISTRATIVE PENALTY
summary or fTiPenalty Policy
Background
The TSCA Civil Penalty Policy, published in the Federal
Register on September 10, 1980, establishes a system for deter-
mining penalties in administrative actions brought pursuant to
TSCA §16. Under that system, penalties are determined in two
stages: (1) determination of a “gravity based penalty” (GBP),
and (2) adjustments to the gravity based penalty.
To determine the gravity based penalty, the following factors
affecting a violation’s gravity are considered:
o The nature of the violation.
0 The “extent” of environmental harm that could result
from a given violation.
° The ‘circumstances” of the violation.
These factors are incorporated in a riatrix which allows de-
termination of the apppropriate gravity based penalty.
Once the gravity based penalty has been determined, upward
or downward adjustments to the penalty amount are made in con-
sideration of these other factors:
0 Culpability,
o History of such violations,
° Ability to pay,
o Ability to continue in business, and
0 Such other matters as justice may require.
The TSCA Civil Penalty Policy system provides a framework
for the development of individual penalty guidances for each
rule promulgated under TSCA. This document sets forth Agency
policy for the use of the GBP Matrix to assess penalties for
specific violations of TSCA §58, 12 and 13 and regulations
promulgated pursuant to these sections.
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—7—
Applicability —______
This policy is immediately applicable and should be used
to calculate penalties for all administrative actions concern-
ing TSCA § 8, 12 and 13 instituted after the date of this policy,
regardless of the date of violation. Pending cases should be
reviewed to determine whether the penalty calculated under this
policy is lower than the penalty in the civil complaint. If
this policy yields a lower penalty, an amendment to the com-
plaint should be made to substitute the lower penalty. This
policy should not be used to raise penalties in existing acti ns.
No case should be settled for an amount higher than the penalty
which this policy would yield.
Calculation of the Gravity Based Penalty —
Penalties for TSCA § 8, 12 and 13 violations vary depending
on tne extent, circumstances, whether penalties are to be calcu-
lated as one day assessments versus per day assessments, and by
capping the number of days for which a violation may be assessed
as appropriate. In establishing each of these, the Agency con-
sidered the following factors In a comparative manner:
o Impact on the Agency’s decision making process.
o Relative degree of harm caused by failure to comply.
o Timeframes in which the Agency decision making process
generally occurs.
o Time to generate information not reported.
o Relative costs of studies.
o Likelihood that sufficient information is available from
other sources.
o Type of information involved, i.e., human exposure versus
animal toxicity studies and allegations versus actual data.
The Gravity Based Penalty (GBP), a function of the nature,
circumstances and extent of each violation, is to be determined
by using the following matrix:
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-8-
EXTENT
I
CI
RCUMSTA
NCES
I A
MAJOR
I B
SIGNIFICANT
C
MINOR
Level
S
1
$25,000
$17,000
$5,000
High
Range
•
2
$20,000
$13,000
$3,000
3
$15,000
$10,000
$1,500
Mid
Range
4
$10,000
$6,000
$1,000
5
$5,000
$3,000
$500
Low
Range
I
6
$2,000
$1,300
L $200
After determining the initial or “base penalty” from the ma-
trix for the first day of violation, add the penalty for each add-
tional day of violation based on the instructions in the “Penalty
for Each Day of Violation” heading. Whether a penalty is to be
assessed as a one day assessment or as a continuing violation on
a per day basis is included in the Circumstances sections. Days of
violation are based on calender days, not workdays.
Nature ____________________
A violation may be either chemical control , control—asso-
ciated data gathering, or hazard assessment in nature. For pur-
poses of assessing a penalty, the nature of a recordkeeping/
reporting violation is “hazard assessment.”
Circumstances
The first step in selecting the base penalty is to deter-
mine which level on the circumstances axis applies to the
violation.
The circumstances axis of the GBP matrix reflects the
probability that harm will result from a particular vio ation.
For recordkeeping and reporting rules, violations rank as fol-
lows on the circumstances axis:
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—9-
CIRCUMSTANCE LEVEL
LFV 1 I Nonreportinq for TSCA §8(e) Per day
Nonreporting for TSCA §8(e) Emergency One day
Incident of Environmental Contamination
Nonreportinq for TSCA §8(d) Per day
Nonreporting for TSCA §8(c) Per clay
Nonreporting for ISCA §8(a) ChemIcal Per day
Specific Rules
Nonreporting for Inventory Update One day
Nonreporting for Inventory One day
Failure to keep records [ not TSCA §8(c)] Per day*
Failure to record TSCA §8(c) allegation One day
False/incorrect/misleading reporting Per day*
LEVEL 2 Failure to maintain records/report in a One day
manner that meets the standard required in
the rule. ISCA §8(c) violatIons are level
3.
Failure to report under TSCA §8(d) involving One day
omission of study in list of studies which a
manufacturer or processor knows of but which
is not in his possession.
LEVEL 3 Failure to report completely after EPA has Per day*
requested missing information or a correc-
tion of erroneus information.
Failure to maintain TSCA §8(c) records! One day
report in a manner that meets the standard
required in the rule. Assess one violation
where all allegations are filed but not in
the manner presrihed.
TSCA §13 Violation (fi rst or otherwi Se) One day
where a positive/negative/no certification
was submitted but the chemical does not com-
ply with other TSCA provisions.
LEVEL 4 Late reporting — For definition of late Per day*
reporting parameters, see the Compliance
Monitoring Strategy for each rule. Does
not apply to the original Inventory Rule,
TSCA §12 and TSCA §13.
TSCA §12 violations after company has One day
received a previous notice of noncompliance
for a violation of TSCA §12.
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-10-
TSCA 1 3 viol ations where a negative/no cer— One day
tification is submitted but the chemical is
subject and chemical is in compliance with
all other TSCA provisions as specified in
the TSCA §13 regulation and the company has
received a previous notice of noncompliance
for a violation of TSCA §13.
LEVEL 5 No violations are level 5.
LEVEL 6 Minor technical omission - Example: omitted One day
name of technical contact but included title
and phone number so the Agency was able to
reach the correct person. (See Notice of
Noncompliance.)
TSCA §8 report sent to incorrect office and One day
was not identified as a TSCA §8( ) submis-
sion as required. —
TSCA §8 report sent to incorrect office and One day
was identified as a TSCA §8 report after
company has received a previous notice of
noncompliance for a violation of the sane
subsection.
TSCA R report sent to correct office hut One day
not identified as a TS( A §R report after
company has received a previous notice of
noncompliance for a violation of the same
siibsecti on.
Failure to keep records showing that the One day
manufacturer is not subject to reporting
under the TSCA §8(a) Inventory Update
Rule.
Extent
The second step in selecting the base penalty for a specific
violation from the matrix is to determine its position on the
extent axis.
This axis of the GBP matrix reflects the extent of potential
harm caused by a violation. In the case of recordkeeping/reporting
rules, harm is defined as the Inability of the Agency to carry out
its risk assessment responsibilities under TSCA.
* One day for Inventory Update, Inventory, TSCA §12, TSCA §13,
TSCA §R(e) ETEC’s, and TSCA §R(d) involving lists of studies
which a manufacturer or processor knows of but which are not
in his poss ssion.
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EXTENT LEVEL
MAJOR Violations of TSCA § 8(c), 8(d), or 8(e)
which involve information which directly
interferes with the Agency’s ability to address
situations Involving potential imminent hazard,
unreasonable risks, or substantial endangerment
to health or the environment.* -
Violations of TSCA § 8(d) and 8(e) involving
human data.
Violations of TSCA §8(e) involving information
on emergency incidents of environmental contam-
ination (EIEC).
All Circumstance Level 2 violations.
All Circumstance Level 6 violatIons,
SIGNIFICANT Violations of TSCA § 8(d) and 8(e) involvIng
animal/aquatic studies, environmental monitor-
ing, workplace monitoring (not invasive human
monitoring), and any other study not addressed
In the major or minor extent level.
Violations of CAIR, PAIR, TSCA §8(a) chemical
specific rules, TSCA §8(c), Inventory, and
Inventory Update Rule except Level 2 or Level
6 violations.
Violations of TSCA §12.
Violations of TSCA §13.
MINOR Violations of TSCA §8(d) involving physical!
chemical práperties or environmental fate data.
* This determination must have written concurrence from OPTS.
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Per Day Assessments
Wflere per day assessments are provided for in the Circum-
stances Level section, the base penalty is calculated for
the first day of violation and per day penalties are assessed
for each subsequent day of violation based on the following
formula:
Violations Involvin 9 Potential Imminent Hazard/Substantial
Endangerment Situations/Unreasonable RIsks
Base X Each day of violation Penalty
Penalty
TSCA §8(e )
Base + ( No. of days of violation — 1) x base penalty = Penalty
Penalty 30
TSCA §8(a) Chemical Specific
Base + ( No. of days of violation — 1) x base penalty = Penaity*
Penalty 360
All others
Base + ( No. of days of violation - 1) x base penalty = penaIty*
Penalty 180
* The number of days of violation cannot exceed caps as
designated in the following section.
Caps on NumDer of Days for Penalty to be Assessed Per Violation
TSCA §8(e) No cap
TSCA §8(d) 5 year cap Major Extent Violations
3 year cap Significant Extent Violations
1 year cap Minor Extent Violations
TSCA §8(c) 1 year cap
TSCA §8(a) 1 year cap
Ch emi ca 1
Specific
PAIR year cap
CAIR 1 year cap
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I nv en tory
Inventory Update
PAIR
CAIR
Chemi cal Sped fic
Determining Number of Violations —_________
Multiple penalties are to be used if there is more than
one violation of the same rule or violations of different rules.
Violations will be determined as follows:
TSCA §8(a)
TSCA §8(a)
TSCA §8(a)
TSCA §8(a)
TSCA §8(a)
Rules
TSCA §8(c) Failure to Keep
Records
TSCA §8(c) Failure to Keep
Records as Required
ISCA §8(c) Report
TSCA §8(d)
TSCA §8(e)
Per Chemical
Per Chemical Per Site
Per Chemical Per Site
Per Chemical Per Site
Per Chemical (Per Chemi-
cal Per Site if Site-Spe-
cific Reporting Is Re—
qui red)
Per Allegation
to Company and
Per Requirement
Per Firm
Per Allegation Not Reported
Per Study Per Chemical
Per Type of Reportable
Effect or Event Per
C n em I c a 1
Per Chemical
try Per Year
Per Shipment
Submi tted
Not Filed
Not Met
TSCA §12
ISCA §13
Per Coun-
Per Port
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Determining the Gravity Based Penalty
The circumstances level and the extent category for each
violation will define a base penalty in the matrix. For those
violations designated as per day in the circumstances matrix,
calculate the penalty as indicated under per day assessments,
taking into account the caps on the number of days the penalty
is to be assessed. This total penalty should be entered on line
1 of the TSCA Civil Penalty Assessment worksheet and adjusted
by the appropriate factors discussed In the TSCA Civil Penalty
System and this policy.
Adjustment Factors
The TSCA Civil Penalty System discusses appropriate adjust-
ment factors. In addition, adjustment factors specific to this
policy are discussed below.
Voluntary Disclosure (Other Factors as Justice May Require) —
The ERP establishes fixed percentage reductions in penal-
ties for voluntary disclosure of violations for the following
sections only: TSCA §8(a) Inventory Rule, TSCA §12, and TSCA
§13. For all other sections, the voluntary disclosure of a
violation is to be treated as a late report, and therefore,
the violator receives a substantial reduction since the
circumstance level moves from Level 1 to Level 4.
For TSCA § 8(a) Inventory Rule, 12 and 13, the adjustment
factors for voluntary disclosure is as follows:
Disclosure ............................. 25%
Immediate disclosure within
3odays of discovery ...................25%
TOTAL 50%
The Agency will not consider disclosure voluntary if the
company has been notified of a scheduled inspection or the
inspection has begun. Information received after these
events will be considered as failure to report/file.
However, if, for example, an inspector is conducting a TSCA
§8 inspection at an establishment, and the company voluntarily
discloses a TSCA §13 violation and the inspector would not
have any expectation of discovering such a violation, the TSCA
§13 vIolation would be considered to be voluntarily disclosed.
This example would also apply to TSCA §12 vIolations. For
TSCA §12 and §13 violations, If a company discloses addi-
tional violations during or prior to settlement negotiations,
those violations are eligible for voluntary disclosure reduc-
tions. The Region nay deal with this situation through:
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1) an amendment to the original complaint; 2) an additional
complaint; or 3) addressing additional charges in the Consent
Agreement and Final Order.
Economic Benefit _________
In no case should the final penalty imposed be less than
the economic benefit. In those cases where the initial penalty
is less than the economic benefit derived from noncompliance,
EPA reserves the right to impose per day penalties up to
$25,000 per day to assure that the penalty is not less than
the economic benefit.
Exposure Reduction (Other Factors as Justice May Require )
In cases warranting per day assessments of the base penalty,
i.e., those involving potential imminent hazard, etc., if the
Respondent has credible evidence by affidavit which shows, for
example, exposure has ceased by all routes of exposure, environ-
mental and/or commercial; that evidence may be considered to
mitigate the penalty. In those cases, the penalty will be as-
sessed at the maxinum base penalty per day during the duration
of the exposure presenting imminent hazard/substantial endanger-
ment/unreasonable risk and assessed as a violation not presenting
the potential hazard/risk/endangerment during the time that
the hazard/risk/endangerment had ceased to exist.
Attitude -
For TSCA 13 violations, if the company had a system in
place to track import certifications and comply with TSCA
§13 requirements, and a chemical “slips through”, a 15% good
attitude reduction may be given as provided for in the TSCA
Penalty Policy. Larger reductions are inappropriate in that
companies are required to comply with certification require-
ments and credit should not be given for attempting to comply
with the law. If a company experiences numerous occasions
where chemicals “slip through” their system, a good attitude
reduction is no longer appropriate.
History of Previous Violation
The Agency will disregard the firm’s prior history of
violations in calculating the penalty for a self-disclosed
violation. However, for violations discovered by the Agency,
the Agency will address history of prior violations as indi-
cated in the ISCA Penalty Policy, even if the prior history
results from a violation which was voluntarily disclosed.
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—16-
Explanation of the Penalty Policy
Nature
TSCA § 8 and 12 require that information concerning
chemicals be reported to EPA or kept at the company and made
available to the Agency. TSCA §13 requires Importers to certi-
fy that chemicals imported are either not subject to TSCA or
are in compliance with TSCA.
Section 8 information Is used by the Agency to evaluate the
potential risks associated with the manufacture and use of a -
chemical. This data gathering often occurs at the early stages
of regulatory decision making. Therefore, complete and accurate
information is essential. Incomplete and inaccurate information
will have far—reaching effects on the Agency’s risk assessment,
regulatory priority setting, and regulation development processes.
Some information such as TSCA §8(e) information may affect the
Agency’s ability to initiate immediate action necessary to pro-
tect health and the environment, e.g., seeking injunctive relief.
In addi tion, reports under the original Inventory Reporting Rule
establish the basis for what is an “existing” chemical versus
a “new” chemical, the latter being those for which a premanu—
facture notice must be filed and the chemical reviewed by the
Agency.
Section 12 collects Information about the export of chemicals
subject to certain proposed or final testing or regulatory requi re-
ments under TSCA § 4, 5, 6, or 7. The Agency provides this infor-
mation to the government of an Importing country to allow that
country to initiate its own risk assessment process.
The section 13 rule describes procedures for certifying that
imported chemical substances subject to TSCA are in compliance
with TSCA. This information permits the Agency to determine if
importers of chemicals are complying with applicable TSCA regula-
ti ons.
Circumstances
The circumstances axis of the GBP matrix reflects the
probability for harm resulting from a particular violaton.
For the reporting rules, the potential harm caused is the harm
to the Agency’s regulatory program for controlling health and
environmental risk. For violations of the original Inventory
Reporting Rule, the potentlalharrn is that a new chemical may
be produced with no prior review contrary to the intent of
TSCA because an Inventory Rule violation resulted In a chemical
being placed on the Inventory which was not an “existi ng” chem-
ical under TSCA. For chemicals which other persons also reported,
the harm deals with the information on the estimated produc-
tion volume and sites of manufacture which the Agency uses in
its risk assessments, including those for TSCA §4 test rule
decisions. For section 12 reporting, the potential harm is
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—11—
to the Agency’s ability to carry out its responsibility to
notify other countries. Thus, violations have the potential
to also harm another country’s regulatory program.
High Range Violations — Level 1
Nonreporting/failure to report or to keep records is an
extremely serious violation of these rules. The Agency will have
to proceed with chemical assessment and priority setting, and
perhaps, even regulation development, especially for TSCA §4
test rules, without critical information or without the knowledge
that such informaton even exists. This is true even if a company
reports some information but does not report each study or under-
reports the extent of health effects or number of allegations for
a particular effect. Thus, each report omitted or Incompletely
reported will be treated as a separate nonreporting violation.
False/incorrect/misleading reporting of information is
equally harmful because the Agency is misled in its analysis of
the potential risks posed by the chemical or in the amounts or
types of information available.
TSCA §8(c) violations in level 1 include failure to keep
records and failure to report if the Agency has requested that
the information be submitted. Thus, if a company has received
ISCA §8(c) allegations, but does not maintain TSCA §8(c) records,
and the Agency requests that TSCA §8(c) allegations be submitted
and the company fails to make a submission, there are two viola-
tions - one for the failure to keep records and another for the
failure to report. Even if a company submits most allegations
but not all, each failure to submit an allegation shall be
separately charged and assessed as a failure to report.
TSCA §8(d) level 1 violations include the following:
— Failure to submit unpublished studies in the
manufacturer’s, Importer’s or processor’s
possession.
— Failure to notify EPA of unpublished studies
the manufacturer, importer or processor
knows of but Is not in possession of.
- Failure to notify EPA of ongoing studies which
the manufacturer, Importer or processor
initiated or sponsored. Includes future studies
required to be reported once they are initiated.
- Failure to send EPA the final report of a
study which was listed as an ongoing study.
Includes future studies required to be
S ubmi tted.
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— Failure to submit underlying data to EPA on
EPA’s request.
Failure to comply with the TSCA §8(e) repnrtinq requirements
is potentially the most serious violation of TSCA §R. TSCA §8(e)
reports alert the Agency to new information which may have a
hearing on the Aqency’s regulatory efforts. This ERP reflects
the seriousness the Agency attaches to violations of TSCA §8(e)
by placing no caps on the penalties assessed for these violations.
High Range Violations — Level 2
Failure to maintain records or report In a manner that meets
the standard required by the rule has effects similar to falsi-
fied Information. Both mislead the Agency and are difficult to
detect. Failure to report in a manner that meets the standard
refers to those cases where reporting is essentially complete
and the missing/incorrect information does not impact the
report in such a manner as to mislead the Agency. An example
Is the failure to report one ongoing TSCA §8(d) study when
another similar study is reported by the company. Another
example is a small error in reporting production volume, i.e.,
less than an order of magnitude (a factor of 10).
Level 2 also includes a TSCA §8(d) violation involving
the failure to report a study which a manufacturer knows of
but which is not in his possession. The Agency considers this
violation to have less potential harm than other failure to report
violations since the Agency Is likely to learn of this study from
other persons reporting.
Mid Range Violations — level 3
Failure to report completely after EPA has requested missinç)
information is a significant violation. Such a violation denies
the Aqency access to information necessary to its analysis of
chemical risks. This type nf violaton is not as serious as the
hiqh ranqe violations because It is usually relatively easy to
detect and therefore easy to remedy. A form, for instance, will
have blank spaces where answers are expected. Even though the
Agency does not have the Information, It knows that an information
gap exists, and therefore, is less likely to be misled Into making
invalid chemical risk assessments. However, the withholding of
information Is a serious impediment to risk assessment, and if
it becomes a widespread practice, it could significantly affect
the Agency’s chemical risk assessment processes. Thus, this vio-
lation, while not as serious as a total failure to report or
false or misleaaing reporting, is still of sufficient severity
to be treated in the higher level of the midrange.
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For TSCA §8(c) files, the failure to maintain reports
as required in the rule, e.g., files which are present hut which
are not cross—indexed or which are not kept in one location, in-
volves a level 3 violation. In those cases where the company files
this information, and the Agency requests the information to he
submitted, and information is not submitted because the company’s
files result in the Information not being discovered during the
company’s file search, the failure to submit is a level 1 viola-
tion. The company may also be charged with the level 3 vIolation.
Please note that failure to file an allegation under TSCA §8(c)
although other allegations are filed constitutes a level 1
failure to keep records violation.
Another level 3 violation involves TSCA §13 violations
where there is a positive/negative/no certification and the
chemical is in violation of other TSCA provisions. TSCA §13
is designed to assure that an importer takes affirmative responsi-
bility in assuring that his shipments comply with TSCA. Where
other TSCA violations are found, a level 3 violatIon will be
assessed plus appropriate penalties for the other TSCA violations.
Mid Range Violations - L.evel 4
Reports which are late can significantly slow or disrupt the
Agency’s decision making process. The exact timing may vary on a
rule by rule basis which will he discussed in the Compliance
Monitoring Strateqies. Lateness is classified in the lower level
of the midranqe circuristanc s category.
In addition, the Agency has decided to treat reports which
are submitted late as late reporting regardless of the date
of submission, with the exception of reports for the original
Inventory Rule and TSCA § 12 and 13. This decision has been
made to encourage the voluntary disclosure of violations by
assessing penalties as level 4 Instead of level 1. For the
original Inventory Rule and TSCA § 12 and 13, a reduction is
provided for the voluntary disclosure of violations. Reports
submitted or viol ations disclosed after EPA has noti fled a
company of a scheduled Inspection will be treated as level 1
failure to report violations, except as otherwise indicated
in the Summary of the Penalty Policy.
TSCA §12 violations other than the first violation are
categorized as level 4. The Agency considers TSCA §12 report-
ing to be important to Its ability to notify other countries
to which chemicals subject to TSCA rulemaking are being exported.
The potential harm is not to the Agency’s decision making process
but to its statutory obligation to notify other countries.
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The Agency considers TSCA §13 violations, other than the
first TSCA §13 violation for which there are no other ISCA viola-
tions, to be mid range level 4 violations. Even if no actual
harm occurs, the violation reflects the importer’s failure to
assure full compliance with TSCA. Failure to certify or filing
a false certification on each shipment circumvents the purpose
of TSCA §13 and could lead to the importation of chemicals
which violate other provisions of TSCA.
Low Range Violations - Level 6
There are no violations which fall within level 5. Level 6
violations include minor technical omissions which do not affect
the Agency’s ability to follow up the Information either by
contacting someone In the company or consulting outside references.
They are among the least serious because the violation Is readily
detected, does not affect initial risk assessment and may only
slightly hinder the Agency’s decision making process. In
cases where there is no effect on the Agency, a notice of non—
compliance rather than a penalty may he appropriate. However,
if a company repeats this type of violation, the Agency will
assess a penalty.
Another level violation is the failure on the part of a
manufacturer to keep records showing that he Is not subject to
reporting under the TSCA §8(a) Inventory Update Rule, which
requires persons who produce less than 1fl,flOO lbs. of a sub-
stance to maintain records documenting that fact.
Other low range violations include a submission of ISCA
§8 information which is not identified as TSCA §8(_)
information and which is not sent to the correct office.
Also, submitting the information to the incorrect office or
not correctly identifying the information after a previous
Notice of Noncompliance has been issued for a violation of
that section warrants a level 6 assessment. Although the
Agency receives the information, it may take some time to reach
the correct office or to be placed into the review process,
and therefore, the Agency’s decision making is delayed or
impeded.
Extent
This factor reflects the extent of potential harm to
EPA’s hazard/risk assessment process. The Agency relies
on Information gathered under sections 8(a), 8(c), 8(d),
and 8(e) to nerforn risk ass ssments. The Agency uses
TSCA 12 and 13 in a different way. TSCA §12 information is
used in order to notify foreign governments. TSCA §13 is used
to assure that ivinorters verify and certify compliance with
TSCA.
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For risk assessment, information may be related to toxi-
city or exposure, both important in determining risk. In
examining the extent of potential harm, the type of information
is important, i.e., human effects data, human exposure data,
an imal data, envi ronmental effects, actual envi ronmental con-
tamination information. Also, scientific studies versus
allegations differ In their Importance.
Major Extent
Violations which directly Interfere with the Agency’s
ability to address potential imminent hazard, unreasonable
risk, or substantial endangerment to health/environment are
placed in the major extent category. This criteria is appli-
cable to TSCA § 8(c), 8(d), and 8(e). Examples of these types
of violations include: 1) Information on Injury to humans
where continued manufacture or use poses a potential Imminent
hazard; or 2) information on a spill/dumping which is covered
by TSCA §8(e) and which posed(s) an imminent hazard or results
in widespread environmental contamination to which persons
exhibit serious health effects. In the second case, two
violations would be charged, one for the failure to report
the spill and another for the failure to report the health
effects.
Other major extent categories include TSCA § 8(d) and 8(e)
violations involving information on human effects. Such infor-
mation can weigh heavily in the Agency’s decision making
process.
Also, violations involving emergency incidents of environ-
mental contamination reportable under ISCA §8(e) are considered
to be of major extent since the Agency needs such information
immediately. Otherwise, the opportunity to provide adequate
protection may be lost.
All level 2 and level 6 violatIons are placed in the major
extent category.
Si gni ficant
The Agency places slightly less importance on animal studies
as opposed to data reporting effects in humans. Nonetheless,
such information is critical to the Agency’s decision making
process. Such tests may be expensive, may take a long time to
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—22-
conduct, and require rulemaking by the Agency to obtain them.
For example, if a company fails to report a study it has, the
Agency may decide that such data are needed and proceed to do
unnecessary rulemaking under TSCA §4. Given the time for Such
rulemaking and the time needed to conduct tests and submit re-
suits to the Agency, the violation results in a major delay in
the Agency’s risk assessment of the chemical and an unnecessary
expenditure in resources, both EPA’s and Industry’s. Please
note that failure to report a study which is required to be re-
ported but which indicates no adverse effects of the chemical
still results In this harm.
The Agency has also decided to place violations involving
exposure related data in the significant category when the
EPA has made a decision that it needs such Information for
a specific chemical. Thus, TSCA § 8(d) and 8(e) violations
involving exposure related information as well as violations
of the CAIR, PAIR, and TSCA §8(a) chemical specific rules,
all of which involve exposure related Information, are consid-
ered to be significant category violations. Although exposure
information is critical to any risk assessment, the Impact on
the Ageny’s decision making if one company fails to report and
all other companies comply is less than if one company fails
to submit a toxicity study since it is less likely that another
company will submit the same study. This distinction is
reflected in the establishment of caps for different types of
violations.
TSCA §8(c) involves allegations and not actual test data.
However, such information is important to the Agency’s decision
making process in that it Involves patterns of effects and
generally involves human effects. Therefore, these violations
are categorized as significant.
TSCA §8( a) Inventory and Inventory Update Rules are also
designated as significant. Although information under these
rules is not required as a result of the Agency identifying
a specific need for information on specific chemicals, this
information provides exposure related information which Is
important to the overall decision making of the Agency in terms
of setting its priorities and deciding what rulemaking to
pursue.
TSCA §12 violations are also considered significant since
such information is necessary for EPA to carry out its responsi-
bility to notify other countries of chemicals for which EPA
has taken certain actions, i.e., a ISCA §5 order or a final or
proposed TSCA § 4, 5 or 6 rule. TSCA §13 is significant in
that violations hinder EPA/Customs’ ability to monitor ship-
ments for compliance with ISCA.
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23
Minor
Two types of violations fall into the minor extent level,
i.e., violations of TSCA §P(d) involving physical/chemical
pro erti s r environmental fate data; and violations of TSCA
§R(a), failure to keep records showing that a manufacturer is
not subject to reporting under the Inventory Update Rule.
The TSCA §8(d) violations are categorized as minor based on
the relatively low costs of such studies and the time it takes
for the study to be conducted. The TSCA §8(a) violations are
easy to detect upon inspection and Information the company
should already have.
Per Day Penalties or One Day Assessments
The Agency has elected to use one day assessments for
violations of rules which require reporting for all chemicals
meeting certain criteria (such as exceeding a given production
volume per site) as opposed to information which is not being
requested on a chemical specific basis. In other words, one
day assessments are appropriate in cases where the Agency uses
the Information to set priorities and may use It as the need
arises on a specific chemical evaluation but has not affirma-
tively Identified a particular chemical for which specific
information is needed.
In those cases where EPA has issued a rule which lists a
specific chemical(s), per day assessments are appropriate because
the Agency has identified a need for the information for risk
identification, risk assessment, or risk management purposes.
Per day assessments also apply to any TSCA §8(e) information
(except EIEC’s which do not meet the potential imminent hazard!
endangerment criteria). Although the information is not being
requested for a specific chemical, it is likely to he used
immediately for risk assessment purposes. Per day assessments
are made for those violations where the continuing violation
continues to impede the Agency’s decision making process.
One day assessment is appropriate for a failure to list a
TSCA §8(d) study which a company knows of but which is not in
its possession. level 2 and level 6 violations are to be as-
sessed as one day. Also, TSCA § 12 and 13 are considered to
be one day violations. As with TSCA §8(e) violations dealing
with an EIEC, violations of these rules do not impede the
Agency’s regulatory decision making process in that such infor-
mation would not normally result in rulemaking. However, such
information Is necessary for more immediate actions such as
injunctive relief or seizing chemicals which are otherwise in
violation of TSCA, e.g., a TSCA §13 chemical imported In viola-
tion of TSCA 5.
Violations involvinrj TSr.A §8(c) fIles, i.e., failure to
record information, are treated as one day violations because
the effect on the Agency’s decision making is not critical
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until the Agency requests the submission of TSCA §8(c) informa-
tion. Once the information Is requested, the Agency has a
specific need for the information to make its decisions. There-
fore, “failure to report” violations under TSCA §8(c) are as-
sessed on a per day basis due to their adverse impact on the
Agency’s decision making.
Per Day Assessment Calculation
For violations Involving TSCA §8(e) information which directly
interferes with the Agency’s ability to address situations in-
volving potential imminent hazard, unreasonable risk, or substan-
tial endangerment to health/environment, the base penalty is to
be assessed for each day of violation. These are the most serious
violations, and therefore, warrant the highest penalties provided
for by the statute.
For other TSCA §8(e) violations, the base penalty is to be
used for the first day of violation. For each day thereafter,
the per day penalty is the base penalty divided by 30. This ad-
justment was selected for the following reasons: 1) these viola-
tions involve significant adverse effects; 2) the Agency has an
immediate need for the information in order to protect the pub-
lic and environment, as reflected in the statute’s language to
“immediately notify”; and 3) the timing of the Agency’s decision
making process once such data is received.
For TSCA § 8(c) and Cd) violations for which per day assess-
ments are to be made, the base penalty is to be used for the first
day of violation and for each day thereafter, the per day penalty
is the base penalty divided by 180. For TSCA §8(a) Chemical Spe-
cific violations the per day penalty is the base penalty divided
by 360. This method was selected in order to provide further
distinction between types of violations and their impact on the
Ayency’s decison making process and its mission to protect the
public and the environment.
Caps — —
In establishing caps for some violations, the Agency took
into account factors such as the length of time that a violation
continues, the timing of the Agency’s decision making process,
the relative costs of studies and the length of time needed if
unnecessary studies are conducted. Please note that the cap
does not refer to a limitation on the time elapsed since the
violation occurred — only a limit on the number of days for
which a penalty is assessed even though a violation continues
for a longer period.
There is no cap on TSCA §8(e) violatIons. The harm
continues as 1 ng as the violation continues.
For TSCA §8(d) studies, which often relate directly to
TSCA §4 rulemaking, the caps depend on the type of study, the
length of time to conduct the study, the relative costs of the
studies, and the timing of the Agency’s decision making.
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—25—
For other TSCA §8 violations for which per day assessments
are to be niade, a one year cap is set based on the estimated
time of the Agency’s decision making process. This decision
also reflects the fact that ISCA §8(a) requirements are more
exposure oriented than toxicity oriented, and therefore, the
quality of the information is sensitive to time. As indicated
in the discussion on extent categories, exposure information
is important but one company’s failure to report may not have
as much of an Impact as nonreporting of toxicity information
because the exposure Information is used in the context of total
exposure. Therefore, these violations are capped at one year.
A chart Is provided in Appendix I which indicates the caps
per violation and their maximum assessments. Caps refer to
maximum penalties for each separate violation; they are no-t
cumulative caps for multiple violations.
Determining Number of Violations
The number of violations depends on the requirements which
are in each rule. Multiple violations are to be assessed when-
ever more than one rule Is violated and for each violation within
a rule. TSCA §8(a) Inventory violations are assessed for each
chemical for which there Is a violation. The Inventory Updat.e
rule requires reporting for each chemical and for each site.
Therefore, TSCA 8(a) Inventory Update violations are assessed
per chemical per site.
Violations of CAIR and PAIR are assessed per chemical per
site. ISCA §8(a) Chemical Specific Rules violations depend
on the information required by the rule. If the rule requires
site specific information, then violations are assessed per
chemical per site. If the rule requires aggregate information
for each company, then violations are assessed for each chemical
not reported/otherwise in violation.
TSCA §8(c) violations are determined depending on the viola-
tion. TSCA 8(c) “failure to keep records” violations and “failure
to report” violations are assessed per allegation not maintained!
reported. This is because the omission of any allegation may
impact the Agency’s decision making process, especially if there
is significant underreporting of allegations. However, a “failure
to keep records as required” under TSCA 8(c) Is assessed per plant
site because these violations involve files not maintained as
prescribed but for which the information Is available. An alle-
gation consists of each report (I.e., one or more pieces of paper)
whereby an lndividual/ group submits an allegation to a company.
If one person alleges that six chemicals produced ten effects
in the same report, and the company falls to file the allegation,
this is assessed as one violation. If two persons file separate
reports regarding the same health effect, and the company does
not file the allegations, this constitutes two violations. If
-------
—26—
a union files a report for 100 persons regarding an allegation,
and the company does not file the allegation, this is assessed
as one violation.
TSCA §8(d) violations are assessed for each required study.
The omission of a single study even if others are submitted may
have a serious impact on the Agency’s decisions regarding a
specific chemical. TSCA §8(e) violations are assessed per type
of effect per chemical not reported. Omission of one significant
adverse effect even if other effects are reported Impedes the
Agency’s risk assessment. -
TSCA §12 violatIons are assessed per chemical per country
per year not reported. This decision was based on the determina-
tion that the export notification requirement Is a one—time
requirement per year for each chemical and for each country of
export. That is, the first time a chemical Is exported to a
country, the exporter must notify the country. Subsequent
exports of the same chemical during the same calendar year to
the same country do not require notification.
TSCA §13 violations are assessed per shipment per port
because the U.S. Customs regulation requires a certification for
each shipment, not for each chemical within a shipment. If the
same chemical is imported on the same day to a port in three
separate shipments, there are three violations.
Adjustment Factors
Voluntary Disclosure
The Agency considers it Important to foster voluntary
disclosures of violations for TSCA § 8, 12, and 13. Most dis-
closures of TSCA §8 violations will be treated as late reporting
and subject to level 4 instead of level 1 penalty assessments,
which provides a voluntary disclosure incentive. For TSCA §8(a)
Inventory violations and TSCA § 12 and 13 violatIons, explicit
reductions for voluntary disclosure are also provided. It is
important to foster voluntary disclosure of TSCA §8(a) Inventory
violations in order to remove chemicals from the Inventory which
were placed there Illegally. Once the Agency knows of this, it
it can act to correct the violation. Similarly, if violations
of ISCA § 12 and 13 are brought to the Agency’s attention, it
can act to remedy the situation, e.g., foreign countries can
be notified or Imports in violation of other sections of TSCA
can be identified and appropriate action taken.
Also, EPA wants to encourage companies to conduct self—
audits and report violations.
-------
—27—
History of Noncompliance
As a further incentive for the voluntary disclosure of
violations, the Agency has decided to forego the imposition of
penalty increases for a previous history of noncompliance In
assessing penalties for voluntarily disclosed violations.
However, a voluntarily disclosed violation does constitute
a history of violation and Is to be used to increase penalties
for future violations which the Agency discovers.
TSCA Section 13 — Who Issues Notice of Noncompliance/Penalty
and to Whom
TSCA §13 may involve imports In one Region by an importer
of record, who is located in another Region and who uses a
broker. The Notice of Noncompliance/Penalty is to be issued
to the importer of record, not the broker, and by the Region
in which the importer of record is located. This Is consistent
with the Inspection Guidelines.
This decision was made for several reasons. If a TSCA §5
inspection Is conducted at the importer of record’s business,
and there is a chemical which has been Imported into three ports
in three other Regions and which Is not on the Inventory, It is
more efficient to issue a Civil Complaint for the one TSCA §5
violation and three TSCA §13 violations than to issue four sep-
arate Civil Complaints in four Regions.
A second reason pertains to the location of the hearing.
If one Region issues the complaint to an importer of record in
another Region, there is a problem of travel, both in terms of
time and money, since the hearing will likely be held in the
Region where the importer of record is located.
A third reason deals with the tracking of Notices of Non-
compliance between Regions in order to know If a company has
received its first TSCA §13 Notice of Noncompliance and is
therefore subject to penalties for subsequent violations.
-------
APPENDIX 1
CAPS FOR PER DAY VIOLATIONS
-------
CAPS FOR PER DAY VIOLATIONS
ALL CAPS ARE PER VIOLATION
8(e) — No Caps
TSCA
1
j8Ld
Nonreporting/False Reporting
Major, level 1 —
Significant, level 1 -
Minor, level 1 —
Late Reporting
Major, level 4 —
Significant, level 4 —
Minor, level 4 —
$278,333 — 5 yr. cap
$120,322 — 3 yr. cap
$15,111 — 1 yr. cap
$111,333 — 5 yr. cap
$42,467 — 3 yr. cap
$3,022 — 1 yr. cap
TSCA §8(c )
Nonreporting/Fal se Reporting
Significant, level 1 —
Late Reporting — 1 yr. cap
Significant, level 4 —
— 1 yr. cap
$51 ,378
$18,133
TSCA §8(a) Chemical Specific rules
Nonreporting/False Reporting
Significant, level 1 -
Late Reporting — 1 yr. cap
Significant, level 4 —
— 1 yr. cap
$34,189
TSCA -
$12,067
-------
APPENDIX 2
E X AM P L ES
-------
EXAMPLES
TSCA §8(a) Chemical Specific Rules (PAIR, CAIR, Asbestos, etc. )
Example 1 - A company fails to report. EPA discovers the
violation. Failure to report, level 1, significant.
Discovered after 181 days — $25,500
$17,000 + 180 X $17,000 $25,500
360
Discovered after 361 days - $34,000
Discovered after 1,095 days — $34,189 (1 yr. cap)
Example 2 - A company reports late. Late report, level 4,
significant.
Report 181 days late - $9,000
$6,000 + 180 X $6,000 = $9,000
360
Report 271 days late — $10,500
Report 730 days late - $12,067 (1 yr. cap)
Example 3 - A company reports under the rule. EPA later
discovers that the information was falsely reported.
False reporting, level 1, significant.
Discovered after 181 days — $25,500
$17,000 + 180 X $17,000 = $25,500
360
Discovered after 361 days - $34,000
Discovered after 1,095 days — $34,189 (1 yr. cap)
Example 4 — A company reports under the rule. The company
later reports that some of the information was inaccurately
reported and supplies EPA with the correct information
within 10 days. Late reporting, level 4, signifIcant.
Reported 181 days late - $9,000
$6,000 + 180 X $6,000 = $9,000
360
Reported 365 days late — $12,067
Reported 1,825 days late - $12,067 (1 yr. cap)
-------
—2—
TSCA §8(a) Inventory and Inventory Update
Example 1 — A company fails to report a chemical on the
TSCA Inventory. EPA discovers the violation. Failure
to report, level 1, significant, one—time penalty.
Failure to report — $17,000
Example 2 - A company fails to report a chemical on the
TSCA Inventory. The company is bought by another company
who, upon checking records, discovers the failure to report
and immediately notifies the Agency. Failure to report,
level 1, significant, one—time penalty.
Failure to report — $17,000
Voluntary Disclosure Policy — 50% reduction of penalty.
Amenaed Penalty - $8,500
Example 3 — A company fails to report 1 chemical at 4 dif-
ferent sites for the Inventory Update. The company is bought
by another company who, upon checking records, discovers the
failure to report and immediately notifies the Agency. Late
reporting, level 4, significant, 4 counts, one—time penalty.
Late reporting, 4 counts - $24,000
TSCA §8(c )
Example 1 — A union contacts EPA complaining that they
submitted 1 report to the company regarding health effects
to 10 workers due to their exposure to chemical X. The
report was presented to the company in accordance with the
rule, and the union provided acknowledgments of receipt by
the company. EPA requested the company to provide all
allegations of health effects due to exposure to chemical
X. The company failed to respond. EPA Inspected the com-
pany’s TSCA §8(c) files six months later and found none.
Failure to keep files, level 1, significant; and failure to
report, level 1, significant.
$17,000 + S17,000 + 180 X $17,000 $51,000
180
Failure to maintain a file $17,000
Failure to report (per day penalty) $34,000
181 days ________
Total 51,00G
-------
-3-
Example 2 - EPA requested a company to submit any al-
legations of effects attributable to chemical Y. The
company reported that no allegations of effects of any
kind were made to them. An inspector visited the com-
pany 2 years later and found a file for chemical V which
included 3 allegations of bird kills attributed to the
chemical. Failure to report, level 1, signIficant, 3
counts.
$17,000 + 364 X $17,000 x 3 = $154,134
180
Failure to report - (1 yr. cap) — $154,134
Example 3 - EPA requested a company to submit any al-
legations of effects attributable to chemical V. The
company reported that no allegations of effects of any
kind were made to them. A year later they contacted the
Agency and informed us that they just found 4 old al-
legations of human effects attributable to chemical V
and submitted the allegations within 10 days. late
submission, level 4, significant, 4 counts.
$6,000 + 360 X $6,000 x 4 = $72,000
180
Late reporting - 361 days x 4 — $72,000
Example 4 - An inspector visited a company and asked to
see the company’s TSCA §8(c) files. The company informed
the inspector that any allegations by workers were kept
in the individual workers personnel files. Failure to
keep files in a manner prescribed by the rule, level 3,
significant, one day assessment, no per day penalty. $10,000
Example 5 — An inspector visits a company and when inspecting
their TSCA §8(c) file discovers that the files are organ-
ized by the health effect rather than by the cause of the
health effect. The files are otherwise in compliance with the
rule. Failure to keep files in a manner prescribed in the
rule, level 3, sIgnificant, one day penalty. $10,000
-------
-4-
TSCA §8(d )
Example 1 - A company submits a list of ongoing studies they
are sponsoring but fails to list a study involving humans.
EPA discovers the violation. Failure to report, level 1,
major.
Discovered after 365 days — $75,556
$25,000 + 364 X $25,000 = $75,556
180
Discovered after 1,095 days - $176,944
Discovered after 2,000 days — $278,333 (5 yr. cap)
Example 2 - A company submits late an animal study in the
company’s possession during the initial reporting period.
Late reporting, level 4, sIgnificant.
Reported to EPA after 365 days — $18,133
$6,000 + 364 X $6,000 = $18,133
180
Reported to EPA after 1,095 days — $42,467
Reported to EPA after 1,825 days — $42,467 (3 yr. cap)
Example 3 - A company submits an animal study, EPA finds ad-
ditional reportable information that the company Intentionally
omitted from the submitted study report. False reporting,
level 1, significant.
Discovered after 365 days — $51,378
$17,000 + 364 X $17,000 $51,378
lug
Discovered after 1,095 days - $120,322
Discovered after 1,825 days — $120,322 (3 yr. cap)
Example 4 — A company submits a list of 9 ongoing animal
studies and later submits 10 studies. Late reporting of one
study, level 4, significant.
Submitted to EPA 365 days after list submitted — $18,133
$6,000 + 364 X $6,000 = $18,133
180
Submitted to EPA 1,095 days after list submitted - $42,467
Submitted to EPA 1,825 days after list submitted — $42,467
(3 yr. cap)
-------
—5—
Example 5 — A company submits a list of studies known to
them but not in ti eir possession. The Agency discovers that
the company failed to list a study they had knowledge of.
Failure to report a study the manufacturer knows of but is
not In his possession, level 2, major, one day assessment,
no per day penalty. $20,000
TSCA §8(e )
Example 1 — A company failed to report a spill within the
time period prescribed in the policy. EPA discovers the
violation. Failure to report, level 1, major, one—time
assessment — $25,000
Example 2 - A company failed to report a spill within the
time period prescribed in the policy. The company reports
their failure to EPA a year after the spill occurs. Late
reporting, level 4, major, one—time assessment - $10,000
Example 3 - A company fails to report a study showing human
health effects. EPA discovers the violation. Failure to
report, level 1, major.
Discovered after 361 days — $325,000
$25,000 + 360 X $25,000 = $325,000
30
Discovered after 1,081 days — $925,000
Discovered after 3,601 days - $3,025,000
Example 4 — A company fails to report a study showing animal
effects not previously reported. The company later submits
it to the Agency. Late reporting, level 4, significant.
Reported after 361 days - $78,000
$6,000 + 360 X $6,000 $78,000
30
Reported after 1,081 days — $222,000
Reported after 3,601 days - $726,000
-------
-6-
Example 5 - A company Submits a study to EPA showing
new animal effects. An inspector conducting an inspec-
tion of the company later discovers reportable information
which was omitted from the study. False reporting, level
1, significant.
Discovered after 1,825 days — $1,050,600
$17,000 + 1,824 X $17,000 = $1,050,600
30
Discovered after 365 days - $223,267
Discovered after 3,650 days — $2,084,767
Example 6 — A company fails to submit human health effects
information which is later characterized by the Agency as
showing a potential imminent hazard. EPA discovers the
violation 90 days after the report was due. Failure to
report, level 1, major. Potential Imminent hazard finding,
$25,000 per day penalty.
$25,000 X 90 $2,250,000
EPD discovered the same violation after one year.
$25,000 x 365 = $9,125,000
EPA discovered the violation after one year and the company
presents credible evidence that exposure ceased after 90
days of the due date of the report. The penalty is calculated
as an imminent hazard for 90 days and as a reduced per day
for the TSCA §8(e) failure to report for the period thereafter.
$25,000 X 90 = $2,250,000
275 X $25,000 = $229,167
30
$2,250,000 + $229,167 = $2,479,167
TSCA §12
Example 1 — An exporter which has received no previous TSCA
§12 Notice of Noncompliance exports 30 chemicals to 30 coun-
trIes with no notifications. Failure to notify. Notice of
Noncompliance.
-------
—7..
Example 2 — An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports one chemical
to one country 30 times during one calendar year with no
notifications. Failure to notify, level 4, significant. —
$6,000.
Example 3 — An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports one chemical
to one country 30 times during one calendar year, notifying
EPA that 5 shipments had already occurred. Failure to noti-f’y,
level 4, significant, voluntary disclosure, more than 30 days
since discovery, 25% reduction. - $4,500
Example 4 — An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violatIon exports the same
chemical to 30 countries with no notifications within the
same year. Failure to notify, 30 counts, level 4, sIgnifi-
cant. — $180,000
Example 5 — An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports the same
30 chemicals to 30 cou’ntries with no notifications within the
same year. Failure to notify, 900 Counts, level 4, signifi-
cant. - $5,400,000
TSCA Section 13
Example 1 — Company imports a chemical with no certification
and which is otherwise in compliance with TSCA. Failure to
certify, level 4, significant.
First time violation: NON
Second time violation: $6,000
Example 2 — Second time violator imports a chemical which is
otherwise in compliance with ISCA at 3 ports on the same day
but has no certification or an incorrect certification.
Failure to notify, level 4, significant, 3 counts — $18,00()
Example 3: Second time violator imports 3 shipments of a
chemical which Is otherwise In compliance with TSCA on the
same day to the same port. Failure to notify, level 4,
significant, 3 counts — $18,000
Example 4 — Second time violator imports 30 shipments which
are otherwise in compliance with TSCA but lack a certification.
Import may be to same port or different ports. Failure to
certify, level 4, signIficant, 30 counts. $180,000
-------
O S?q .
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON,D.C. 20460
PRO1 ’
OFFICE OF
PPR 1 8 1997 ENFORCEMENT AND
COMPLIANCE ASSURANCE
MEMORANDUM
Subject: Penalty Policy supplements pursuant to the Civil Penalty Inflation Adjustment Rule
From: Jesse Baskerville, Director , iA ( aACiL
Toxics and Pesticides Enfo#èfñent li vision
To: Regional Toxics and Pesticides Division Directors
Regional Counsels
Toxics and Pesticides Enforcement Division (TPED) personnel have reviewed all civil
penalty policies within its purview to update them and ensure consistency pursuant to a new rule
published on December 31, 1996, in the Federal Register (61 FR 69360)— 40 CFR Part 19 and
27, in accordance with the Federal Civil Penalties Inflation Mjustment Act of 1990, as amended
by the Debt Collection Improvement Act of 1996 rDCLA”). The rule, which was effective
January 30, 1997, increases the statutory penalty provisions by ten percent (10%). A complete
List of all our existing penalty policies (Attachment A) is provided along with instructions
necessary to implement this new rule and update each specific Enforcement Response Policy.
The increased maximum penalty amounts are reflected in the attached matrix supplements
for the respective penalty policies. (See attachment B for directions for incorporating the revised
matrices into the existing penalty policies. Note: These increases in the Civil Monetary Penalties
apply only to violations which occur after the date the increases took effeci January 30. 1997 .
Violations prior to this date should continue to be assessed using the matrices in the existing civil
penalty policies (Attachment A).
RecycledlReCYclable • Pnnted with Vegetable Oil Based lnl on 100% Recycled P er (40% Postconsumer)
-------
It is important that these changes be made promptly, since all Enforcement Response
Policies are sent to Respondent along with the administrative complaints issued to them. If you
have any questions, please call Robin Lancaster at (202) 564-4172.
Attachments
cc: (w/attachments)
EPCRA Regional Coordinators
FIFRA Regional Coordinators
TSCA Regional Coordinators
EPCRA Enforcement Coordinators
FIFRA Enforcement Coordinators
TSCA Enforcement Coordinators
-------
ATTACHMENT A
TSCA
Record keeping and Reporting Rules TSCA Sections 8, 12, and 13 (8/5/96)
PCB Penalty Policy (4/9/90)
TSCA Section 5 Enforcement Response Policy (8/5/88; and amended on 6(8/89
and 7/1/93)
TSCA Good Laboratoiy Practices Regulations Enforcement Policy (4/9/85)
TSCA Section 4 Test Rules (5/28/86)
TSCA Title II- Asbestos Hazard Emergency Response Act (AHERA)
Interim Final ERP for the Asbestos Ha7Md Emergency Response Act
(1/31189)
ERP for Asbestos Abatement Projects; Worker Protection Rule (11/14/89)
EPCA
Final Penalty Policy for Sections 302, 303, 304, 311, and 312 of EPCRA and Section 103
of CERCLA (6/13/90)
Enforcement Response Policy for Section 313 of EPCRA and Section 6607 of the
Pollution Prevention Act (8/10/92)
FIFRA
General FIFRA Enforcement Response Policy (7/2/90)
FIFRA Section 7(c) ERP (2/10/86)
Enforcement Response Policy for the Federal Insecticide, Fungicide, and Rodenticide Act:
Good Laboratory Practice (GLP) Regulations (9/30/91)
-------
AT ACI1MENT B
p uLTy POLICY DIRECTIONS
ThEA
Record keeping and Reporting Rules TSCA Insert Matrix (p. 7-A) behind page 7
Sections 8, 12, and 13(8/5/96)
PCB Penalty Policy (4/9/90) Insert matrix (J). 9-A) behind page 9
TSCA Section 5 Eâforcement Response lflseit matrix (p. 16-A) bdiind page 16
Policy (8/5/88 and m ded on 6/8/89 and
7/1/93) -
Insertmatrik(p.’4-A)behindpage4
TSCA Good Laboratory Practices
Regulations Enforcement Policy (4/9/85)
Insert matrix (p. 2-A) behind page 2
TSCA Sectio,i 4 Test Rules (5128/86)
TSCA Title II- Asbestos Hazard Emergency
ResponseAct(AHERA) Inseitinatrix(p. 11-A)behindpagell
Interim Final ERP for the Asbestos
Hazard Emergency Response Act
(1/31/89) - for LEAs
Insert matrix (p. 17-A) behind page 17
Interim Final ERP for the Asbestos
H 7Md Emergency Response Act
(1/31/89) - for other persons
ERP for Asbestos Abatement Projects;
Worker Protection Rule Insert matrix (p. 6-A) behind page 6
Interim final Enforcement Response Policy-
Asbestos Abatement Projects; Worker
Protection; Final Rule” (11/14/89)
£ C&t
Final Penalty Policy for Sections 302, 303,
Insert Matrix entitled, “Table II , Base Penalty
304, 311, and 312 of EPCRA and Section
103
Matrices for Violations which occurred after
of CERCIA (6/13/90)
January 30, 1997, pp. 20a & 20b, behind p.
.
20,untilsuchtimeasarevisedpolicyis
issued. In the alternative, attach this memo to
the penalty policy.
Enforcement Response Policy for Section
313
Insert matrix entitled ‘EPCRA §313 Gravity
-------
I(WRA
General FIFRA Enforcement Response Policy
(7/2/90)
FIFRA Sec ion 7(c) ERP (2/10/86)
Enforcement Response Policy fbr the Federal
Insectidde Fungicide and Rodenticide Act:
Good Laboratory Practice (GLP) Regulations
(9/30/91)
Inseitafterpage l9in thepolicyandpageC-
intheappendix
No insert.
While the FIFRA ERP (1990) does not
supersede the Section 7(c) ERP (1986), the
matiix setting forth the penalties in the 1990
ERP should be used instead of the matrix in
the l986poicy
No Insert.
When proposing penalty amounts under the
Enforcement Response Policy for the FIFRA
( 312 Regulations, dated September 30, 1991,
actual dollar amounts are determined by tsing
the ERP for FIFRA (7/2/90). (see directions
above for General FIFRA ERP)
-------
Page 2-A
*(i.ayjty Based Penalty Matrii For Violations Which Occur Mter January 30, 1997
TSCA 4
GRAVfl’Y BASED PENALTY MATRIX
QRCLThISTANCES-
(probabitityof.. A’’
es or
ThT
•.
B
Sig ilieant
‘
C
Minor
VEL
1
ZflgbRa g:
2
$27,500
—
.
$18,700
--
$5,500
.
--
3
MidRange’
4
5
Low Range
6’
$16,500
.
$11,000
$5,500
$11,000
$6,600
$3,300
$1,650
$1,100
$550
$2,200
$1,430
$220
* Gravity based Penalty Matrix to supplement TSCA Section 4 Test Rules Enforcement
Response Policy (5/28/86) for violations that occur after January 30,1997. Insert behind
page 401 TSCA Section 4 Test Rules Enforcement Rsesponse Policy (5I28I86)
-------
Page 4-A
*(i.avjty Based Penalty Matrices For Violations Which Occur After January 30, 1997
* CA LP
GRAVITY BASED PENALTY MATRIX
* Gravity Based Penalty Matrix to supplement TSCA Good Laboratory Practices
Regulations Enforcement Policy (4/9/85) for violations that occur after January 30, 1997.
Insert behind page 4 of TSCA Good Laboratory Practices Regulations Enforcement Policy
(4/9/85)
7 5 ” ’m .
STANCES
A ‘1
Ma’oi
B
$i n
C
1 $27,500
2 —
•
$18,700
—‘
$5,500
. 5 - -
3 $16,500
Range
--
$11,000
--
$1,650
--
S $5,500
Range
6 - -
$3,300
--
$550
--
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Page 6-A
Asbestos Worker Protection
t Gravity Based Penalty Matrix for Violations Which Occur Mter January 30, 1997
TEx t
(Levek). LEVEL
‘ MAJOR +
Eitent
LEVELB
SIGNII cA?fl’
LEVEL C
: i UNOR
‘. $27,500
. .. . $22,000
$18,700
$14,300
$5,500
$3,300
$16,500
$11,000
$11,000
$6,600
$1,650
$1,100
$ 5;500
$ 2,200
$3,300
$ 1,430
$ 550
$220
* Gravity Based Penalty Matrix to supplement Interim Final Enforcement Response
Policy— Asbestos Abatement Projects: Worker Protection: Final Rule (11114/89) for
violations that occur after January 30, 1997. Insert behind page 6 of Interim linal
Enforcement Response Policy— Asbestos Abatement Projects: Worker Protection: Final
Rule (11/14/89).
-------
Page 7-A
*Gravky Based Penalty Mafrix For Violations Which Occur Mter January 30, 1997
TSCA if 8, 12, & 13.
GRAViTY BASED PENALl Y MATRIX
cr
cmculwsTmcssI. •‘
.:i ’ A
L Ma r
wzr rL
‘.:
SQsificant
. ‘
c
M i nor
I “ $27,500
2 ‘ $22,000
$18,700
$14,300
.
$5,500
$3,300
3 $16,500
4 $11,000
5 $5,500
Range
$11,000
$6,600
$3,300
$1,650
$1,100
$550
$2,200
$1,430
$220
*Gravity Based Penalty Matrix to supplement Recordkeeping & Reporting Rules TSCA
Sections 8.12. and 13 for violations that occur after January 30, 1997. Insert behind page
7 of Recordkeenine & Renortinf Rules TSCA Sections & 12. and 13 ( 8/5/961 .
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Page 9-A
*Grayfty Based Penalty MatrixFor Violations Which Occur After January 30, 1997
TSCA § 6 (PCB)
GRAVITY BASED PENALTY MATRIX
* Gravity Based Penalty Matrix to supplement PCB Penalty Policy ( 419/90 ) for violations
that occur after January 30 1997. Insert behind page 9 of PCB Penalty Policy ( 4/9/90 )
S
NZS
(jirIbabiltyd’. A
ea Maor
‘EXTENTS
•
Signil cant
‘ ‘ S
:
Minor.
S
1 $27,500’
HighRange’
2 $22,000
‘
$18,700
$14,300
$5,500
‘
$3,300
$16,500
$11,000
5 . $5,500
Range
$11,000
.
$6,600
$3,300
$1,650
$1,100
$550
6 ‘ $2,200
$1,430
$220
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Page 11-A
Base Penalty Matrices For Violations Which Occur After January30, 1997
EPCRA § 313
GRAVITY BASED PENALTY MATRIX
F T 1 T
A
:U1
B
Si** Ic*flt
MJflO
$27,500
$18,700
$5,500
I . $22,000
$14,300
$3,300
‘3’ “ $16,500
$11,000
$1,650
4 $11,000
$6,600
. $1,100
5 $5,500
$3,300
$550
6 $2,200
$1,430
$220
*Gravity Based Penalty Matrix to supplement the ‘Pmal EPCRA §313 Enforcement Response
Policy” (8/10/92). Insert behind page 11 of the “Final EPCRA §313 Enforcement Response
Policy” (8/10/97).
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Page 11-A
*Gravjty Based.Penalty Matrices For Violations Which Occur After January 30, 1997
for
ARERA Interim Final ERP (1/31189)
Base Penalty for LEA’s
(Levels)
‘
‘
.
LEV LA
MAJOR
( 3,000sq.ft.
orl000Iinear
‘ft.)
LEVEL B
$IGNMCM
() 160 sq.ft or
26Oliflearft.
but<3,000
sq.ftor l,000
linear ft.)
s.S
LEVEL C
MINOR
(
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Page 16-A
*yjty Based Penalty Matrix For Violations Which Occur After January 30, 1997
TSCA § 5
GRAVITY BASED PENALTY MATRJX
* Gravity Based Penalty Matrix to supplement TSCA Section 5 Enforcement Response Policy
(815 /88) for violations that occur after January 30, 1997. Insert behind page 7 of TSCA Section
5 Enforcement Response Policy (8/5/88).
S
CIRCUMSTANCES
A
S. ‘ Maor
•:EXIENT”
5 5 B
j t ’
S
-
5 C
Minor
$27,500
I $22,000
$18,700
.
$14,300
$5,500
-
$3,300
3 $16,500
MMRange
4 $11,000
$11,000
$6,600
$1,650
$1,100
5 $5,500 ‘
Range
6 $2,200
$3,300
$1,430
$550
$220
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Paga ?J-A
ARERA- “Other Persons -
*Grayj y Based Penalty Matrix for Violations Which Occur After January 30, 1997
• LEVELA 5
i 1
4 LEVft B
*GN1I.1 rN,I .
:
LEVEL C
. .
S $27,500
2 $22,000
$18,700
$14,300
$5,500
$3,300
$16,500
$11,000
$ 5,500
6 - $ 2,200
$11,000
$6,600
$ 3,300
$ 1,430
$1,650
$1,100
$ 550
$220
Note: >= greater than;<=less than.
* Gravity Based Penalty Matrix to supplement Interim Final Enforcement Response Policy
for the Asbestos Hazard Emergency Response Act (1/31/89) for violations that occur after
January 30, 1997. Insert behind page 17 of Interim Final Enforcement Response Policy for
the Asbestos Hazard Emergency Response Act (1/31/89).
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Page 19-A
*Gravftjl3asedPcnafty Matrix For FIFRA Violations Which Occur Mter January 30,
1997
FIFRA § 14(a)(i)
SIZE OF BUSINESS
7
L IIWZL2
$5,500
$5,500
$5,500
$4,400
$5,500
$3,300
:.
$4,400
$3,300
$2,200
LEVEL4
$3,300
$2,200
$1,100
FJFRA § 14(a)(2)
SIZE OF BUSINESS
.LtflL I
f l
I
Ill
• IEVZL2 $1,100
$1,100
$880
$1,100
$660
LEVEL3 $880
$660
$500
*Gravity Based Penalty Matrix to supplement General nERA Enforcement Response
Policy(ERP) (7/2/90) and the h ulA Section 7(c) ERP (2/10/86) for violations that occur
after January 30, 1997. Insert behind page 19 and page C-i in the appendix.
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Page 20-A
Table II
Base Penalty Matrices For Violations Which Occur After January 30, 1997
CERCLA § 103 and EPCRA § 3041
GRAViTY (Quantity Released)
E
(tünclin
notifi
•
XTENT LEVELA
ess of ‘. (greater sJi
cation) 1$ times the
‘ - R
LEVEL
(greater than 10
but less than 15
. n the1O)
J C
‘(jre t than 1 bat
làss a 10 times
., the$fl)
IZVEL1 ‘ $27,500
(more than 2houii - $20,626
$20,625
$13,751
$13,750
$6,876
IZVEL 2’ • $20,625 $13,750 $6,875
(between 1 and 2 $13,751 $6,876 $3,439
hours)
LEVEL3 ‘: $13,750 $6,875 $3,438
(wIthin 1 hour, afte, $6,876 $3,439 $1,718
l5ininutes)
EPCRA 312
GRAVITY (Quantity Present)
EXTENT LEVEL A LEVEL B LEVEL C
(timeliness of MSDS (greater than (greater than (great thá I but
submission) 15 times the 10 but less than less than 10 times
TPQ) 15 times the the Th )
LEVEL I $27,500 $20,625 $13,750
(more than 30 days) $20,626 $13,751 $6,876
LEVEL 2 $20,625 $13,750 $6,875
(after 20 but within $13,751 $6,876 $3,439
30 days)
LEVEL 3 $13,750 $6,875 $3,438
(after 10 but within $6,876 $3,439 $1,718
20 days)
1 While the pena1 y amounts in this matrix apply to EPCRA § 304(c), the criteria associated
with the levels do not apply. To determine the appropriate extent level for violations of § 304,
seep. 13,infra.
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Page 20-B
Table II (continued)
Base Penalty Matrices For Violations Which Occur After January 30, 1997
EPCRA 311
GRAViTY (Ouantitv Present)
EXTENT LEW LA
(timehnss of MSDS (greater than
subs ission) 15 timà the
+ PQ).
ZZVEL II
(greater than
10 but less than
LEV1 C.
(great th i I but
less than 10 t nIes
t$T )
S
(mor $I’qn3O days)
$11,000
$8,251
$8,250
$5,501
$5,500
$2,751
LEVEL 2
(*fier2Obutwithin
3odays)
S LEVEL 3
(after lObutwithin
2Odsvs )
$8,250
$5,501
$5,500
$2,751
$5,500
$2,751
.
$2,750
$1,376
$2,750
$1,376
.
$1,375
$688
*(1.avity Based Penalty Matrix to supplement Final Penalty Policy for Sections 302.303.
304.311. and 312 of EPCRA and Section 103 of CERCLA (6/13/90) for violations that
occur after January 30, 1997. Insert be)nnd page 20 of Final Penalty Policy for Sections
302.303.304.311. and 312 of EPCRA and Section 103 of CERCLA (6/13/90).
-------
-------
‘., . ,.
,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
.. WASHINGTON. DC. 20460
c
NOV OFFiCE OF
MEMO RA DUM
TC: Richard J. Denney,
Associate General Counsel
Toxic Substances Division
SUBJECT: fleutral Administrative Inspection Schemes for TSCA Enforcement
Attached for your review are neutral administrative inspection
schemes for three TSCA enforcement programs - premanufacture notification
(Section 5), inventory (Section 8) and chiorofluorocarbons (Section 6).
We request your opinion, pursuant to Joan Bernstein’s memorandum of
June 28, 1978, as to whether these three schemes meet the requirements
for a neutral administrative inspection scheme as described in the
“ arshall v. Barlow’s, Inc . decision of May 1978.
The principal persons who developed these schemes are Jonathan Libber
(Section 5), Barbara Paul (Section 8) and Judy Kosovich (CFC). All may
be reached at755-94O4.
A. E. Conroy II,, Director
Pesticides and I lcic Sub’stances
Enforcemen O ’ t ion
cc: Richard 0. Wilson
Attachment
-------
EuTR ’ ,YvlF:1STRr TIvE I! SP1.CTIO I FOR SECTION 5
________________ — ——
Intr uctior c th2fc uLtalAdn nistrative Ins ecLi n Sche’ re
The following rc b;o neutral ministxative inspct n sche ’nes for use
in t etir 3 ir ctions. This saction of T 3C daals ;ith Pre—
z ar .if cthre ‘Zc ification (P4N). The P pror n is in its initial
sta;es ar rr ny of the prograr elc ’ ts wil]. not beccn e fully o rational
until so; • tir in the middle of r 80. Thus the Crficr of Enforcerrent
(CE) is -c sir both an initial s .her to cover this interim period
ar a final one t becore effective t en the 95 progra r is fully
2ratonal.
‘Th rc ore se’.’en violation categories i i Saction 5: 1) ncn 1iar.ce
with a Section 5(e) or Section 5(f) order, ru]. or injun ti n, 2) failure
t i- tify Ei’ \ cC the çro uct .ion of a new substance, 3) mnar facture of
a fl el £ub5t n ;ricr to the expir: tion of the p r.awfncture notice
ricd, 4) ueir. a substance rcducod in yb t oc of S for
-------
ca r rcthl purp e , 5) nonc.ar pli nce with thr. terms of a test ii:} ting
exemption, 6) noncc’np]W’nce with the terms of a rescarth arx 1 CV 10pTI nt
cxoi ption an:3 7) violation of Sigrdfic.ant Ucw Use Rules ( UP S). DUL-In;
the first sevc ral ironths of operation, CE anticipates that the only
active violation c.3tegDries will be: 1) failure to noLi y, 2) production
prior to notice piration anc3 3) canm rcial use of an properly - )uc 1
substance. Thus CE’s initial efforts will focus on these thrcc categories.
When the other categories becane active, CE pill shift to the innl- naitral
a minisixative inspection scheme c ith includes the othcr violati’r c nLe’prics.
or reco ni es that the scher ’ss will thane as the Agency develcps expertise
in hardling th enforcen nt of 5.
The sche!tes presc-nt belcw list the violation categories and the crilericri—
defined subcategories. In those categories where less than lOOt of the
n rthers of a psrticular category will be inzpect , the scherr presents
neutral criteria u n uhich ir.spection targ3t.ing will be baoe 5. Thus in
all categories but the S5(e) ard S(f) orders, rules and injunctiors
category, only a percenLe. e of the r a:r5ars of a category will be insp c.ted
on the basis of tageting criteria. Each criterion d2fin s a subc t .gcry.
cr example, there are eight subcategories in the Failure to Notify
violation: 1) all rerr ers who are the subject of failure to notify tips
and/or complaints, 2) all firms that have that have applied unsucceisfully
for PI exetions, 3) all firms that have initia cd but n ver cc lct d
P N submission, 4) all ftrm. with a history of new chem caJ. vclop: nt: ,
5) firms cse P submission in3i.c itcd significant lovelo of project
PrOduct .on, 6) f rmz with a history oL to:: .c uL sLanr. r cducLion (: 3.:.rr]
Induotrial Cl . ificat:on ( T.C) c.o oc 2:121 —. Pl t:ic . rt ri 1s, Synth t c
-------
Resins an Non VulcQncblc Ela3t.o.1r.rs, 365 — Cyclic Crud s Cyclic
Tht,ermediates, Dyc i rd Crcj n&c Pigr 3ntz, nn 3 2869 — Industziztl Chomicals
Not Else icre Ciazsificd, 7) firm i wh have violatc.cl certain Fc& a1
cm,iron ntal tirWor 5aCety staLutes (FIERP , RC A, CM, FWPCA ar CSIL’ )
ar 8) a ran orn selection of the the!nical firms,
t slould b r.ot that if any of these tziggerir 3 criteria uce a
subcategory that is tco large, the selections in that subcategory can
be ran3onized. For example, if there are cnly enrxigh resources to is cct.
50% of the rr ar bors of a subcategory, OEwill select half of the meirbars
on a rardo basis.
OE.inLer s to re;ie z the efficacy of these targetir criteria by
statistically evaluating the violation rates of each criterion—defined
subcat çory in cc parison with the rarx i subcategory of the sane
violation caLe ory. In this way, QE will d Le ine if there are sigriific int
differences bet een the rate of violation of a particular criLericn—de in-
subcategory and the ranicrn selection of the rbers in that entire
violat cn cateory. If there is no significant difference, then OE :ill
realize that the criterion in question is useless.
The order of the violation category ar of the subcategories irdicates
the Friority az ng th2 categories and subc.ate ories.
Ln t c •
A. Failure to Notify
1. all or w:,o are the cubjcct c LL ro er pr 1ucticn tips ard/or
c tpla inL3
-------
-.4 -
2. all firms that app1 c d c.es fuUy for 1’ N c’xcii’pt sx
3, all C tLm’ that have ,.nl .t .atc. .3 t.ut never ipl WJ E? Z’ sub nission
4 • aill C irm wit.h a hi Lnry f nc w hc iical p cc1uc.twn
5. firms P t1 suLtuthson ir iC 3 .rd si niCicnnt: levels of projccL 1
prod icLiort (lorf a) o ar i ‘i lr a 1irq variety)
6. firms with a hi t ry of hi::,’hly toxic. substance producticn (by SIC
c.oclcs 2C21, 2365 arri Z369j
7. prc ’iow violators of ccriath federal erriirontiental protection
and/or safet.y staLuteS
8. rardcc selection of all thernica]. producers
B. Production Prior to P otic.e Expiration
1. all catcqory m 5ers ho are the subject.. of prior production
carplaints and/or tics
2. all firms that h ’e been the subject of notice c tens ions
3. rardorn selection of firms that have not had their notices
ex ter& 3
4 • all t ory rrv rbers ho are violators of federal err iror ntal
and/or safety statutes
5. rard n selection of all firms undergoing P •:
C. . Cai rcial Use Vioiatior
1. all firms liste5 as recipients of iirproperly produced chemicals
2. firms listod cn SIC co s 2a21, 65 ard 69
3, ran an selection of all the iical firms
A. ViolaUons of Sect:cn a(c) or 5(1) Crd rs, Rules Cr Injunctions
1. inspec.t all i irms subj2ct to such orders, rules or injunctions
3. Failure to Notify
2,. al]. rr .5ers ho are the subject of irr . zoper production tips
and/or cc )aints
2. all firms that a plieJ unsucc ssful1v for P ! xe; tior.s
3. all firms that have init. .atc.d but never cc rotetcd a P L’ submission
4. all firms n.th a his ry of n the iic l producLion
5. firma w oze p i suh aission indic.at:ed si iftcant levels of projected
production (for Eals ar :i mi l2a i.r variety)
6. firms zith a hi t.c v cf h gh1v to :ic tance oduction (by SIC
co ]es 2321, 65 arci 2369)
7. prre;ious vtolaL rc of certain federal e’iror nLal protection
and/or cafet: stW uez
8. rardo lucLicn c all c2micai p :cducer ;
-------
C. Product ion Prior to P121 Notice Expiration
1. al] category mz Ither3 ! t o are the subject of prior production
c npla i.nL and/or t
2. all. finns that h vc been thc! subject of notice extcns ions
3. random rdc’cLion of firms th t have not had their noLicc
ex ter 3od
4. all category r ir ers who arc violators of federal erwhonmenLal
and/or safely stalutues
5. randc* select .on of all firms undergo .ng pz.i
D. Cccr nercial Usc Violations
1. all firms lislod as recipients of improperly produced chemicals
2. firms listed on SIC codes 2 32l, 2 65 and 69
3. rarr3cxn selection cf all ther iical prcducers
E. Violations O Test Marketing Reslric ions
1. all category m2ir.’ ers that have been the subject of tips or
cat plaints suggesting test rrarketing violati.or.s.
2. all firms p oducting hthhly toxic lest marketed items
3.all firms p .-oducing test marketed item.s in high da r
4. all cat c ’ we ars who have violated certain federal
envirorirental selection of cate ory me ers
5. ran an selection of cat ory tn r rs
F. Violations of Research and Developn nt Restricti ris
1. all firms that are the subject of tips ar /or c nplainLs
indicating violat.cn cf this exp i n
2. rar selection of thase firms ldin the sclves out as
s x cialty th mic. l fir: ’s
3. rar i selection of all chemical producers
C. S U S — criteria t be later ãeter ines
-------
Inventory Reporting Regulations 1eutra1 Administrative
inspection Schemes:
OE will select persons for inspection to monitor compliance with
inventory reporting requirements in the following manner:
Violation : Reporting a Substance Excluded Because for Research and
Development
inspection Scheme
OE will select persons for inspection to ensure that they have not -
reported substances manufactured or imported for research and development
based on a combination of the following methods:
o CE will obtain from the inventory a list of substances
manufactured or imported in quantities of less than 1000
lbs/year, reported by known manufacturers of R & D sub
stances, and not reported in larger quantities by other
persons.
o OE will compare the inventory with public lists of substances
manufactured prior to 1977 to isolate substances appearing
on the inventory but not listed elsewhere as having been
manufactured prior to 1977.
CE resources n ay be inadequate to inspect all firms identified. In
this case OE will a1 habetize firms identified and inspect every nth
firm, where n = the number of firms identified divided by the number of
inspecticns which can be performed with the resources available.
-------
Violation : Late Reporting/Failure to Report
Inspection Schen e
EPA will search for manufacturers and importers who failed to
report by ay 1, 1978 as required and whose substances are being reported
by processors during the revised inventory reporting period in the
following c anner:
o OE will obtain from OTS names of processors reporting for the
revised inventory.
o OE will request from each processor a certification that
he is not also a manufacturer of the substance.
o If the processor is not a manufacturer of the substance, OE
will request a list of the processor’s suppliers.
o DE will contact each supplier and ask for certification that
he was not required to report for the initial inventory (i.e.,
substance was not manufactured/imported after January 1, 1975).
If OE resources are macequate to inspect all firms identified,
CE will alphabetize suppliers and inspect every nth firm.
(n = the number of suppliers identified divided by the number
of inspections which can be performed with the available
resources.)
-------
Violation : Reporting a Substance Excluded &ecause Not rianufactured,
Processed, or Imported Since January 1, 1975.
Inspection Scheme
EPA will select persons for inspection to ensure that they have not
reported substances not manufactured, processed or imported since January 1,
1975 in the following manner:
o CE will compare substances reported for the inventory with the
commercial lists of substances manufactured in 1975, 1976 and
1977.
CE will alphabetize the manufacturers and importers of substances
identified by the above comparison and inspect every nth one. (n the
number of manufacturers and importers identified aivided by the number
of inspections which can be perform with the available resources.
In FY79 and FY80 during the revised inventory reporting period CE
will commit its resurces to inspections under these schemes as follows:
Compliance •onitoring to Detect 4O
Reported R & D Substances
Compliance onitoring to Detect 30
Substances not t anufactured or imported
after 1975.
The rei aining 30 of total GE resources il1 be used to
respond to reports of other violations.
Each Region will not necessarily conduct an equal number of inspections.
Inspections will be assigned Regions based on the location of the potential
violators as indicated by each inspection scheme.
-------
CFC mile — eut.ral Ir.p c .tion Scheme
The rule published by EPA on March 17, 1978 (43 FR 11310) bins processing
of fully h 1oen Led ch1orofluoti anes (CFcs) for ac o1 prope1L nt uses
after D cc!rb r 15, 1978, e ccpt for certain essential uses. Such processing
woild be done by businesses in as aerosol fillers.
1. The records of CFC manufacturers will be ins ect€d once a year to determine
which aerosol fillers are currentJy purchasing CFCs.
2. Only aerosol fillers who have purchased CFCs in the year preceding the
proposed inspaction or zho are other .iise knc n to be in a sition to fill
aerosols with CFCs will be candidates for inspection. Such fillers will be
jdenLifi .) by inspactions of the records of CFC manufacturers, by information
from the Cortsuit r Products Safety Cc nission (CPSC), or by other n ans,
3. Such card idates for inspact ion will be ranked according to the relative
quantity of CFCs esLU’ated to have been received. This ranking ii1 termir.e
the insp2ction priority. If the arount purchased in unknown, the filler will
be assigned a ranking in the middle of the ranked list.
4. A ranked list of candidates for ins ction will be sent to each Regioj al
Office. Such lists may later be aitended. The total nurr.ber of aerosol fillers
to be ir.s cted in a gwen fiscal yea.r wi].l be determined. The ranked l st
will be used toidentifv the particular fillers to be inspected. The total
nirrber to be inspected in each Region will be approxi rate1y çroçcrtiona]. to
the fra.ticn cf fillers in that region subject to this sche .
5. The sequence shall be rank order of the list, exc.e2t that this s cjueriCe
be adjusted to ccnser;a Agency resources.
6. Inspections Cf fillers who have never been ia5 c.ted prey icusly have higher
pricrity, ranked according to cuantities purchased, than ir.specticn of fillers
w ro have been ir.spacted previcusly (not including raitine fo11 -up inspacL.on )
7. If all fillers have been inspected at least once, fillers should be ranked
acc.ording to their estin ated like1yho of recidivi!m.
-------
Use of TSCA Section 11(c) Subpoenas
Prepared by:
Pesticides and Tcx c Substances
Enforcement Division
December 4, 1979
-------
TABLE OF CONTENTS
page
I. Introduction 1
II. When Subpoenas Should Be Used 1
III. Defenses To Subpoenas
A. Generally 4
B. The requirement that the subpoena be 5
within the authority of the agency
C. The requirement of relevancy -7
D. Vague or unduly burdensome subpoenas 9
E. Privilege
IV. Form And Service Of Subpoenas 10
V. Enforcement Of Subpoenas 13
Append ices
A. TSCA Section 11(c)
B—i. Subpoena Duces Tecum
3—2. Subpoena Ad Testificandum
5—3. Return Of Service
3—4. Receipt of Subpoena Response
C. TSCA Delegation 12—i, Inspections
And Subpoenas
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I. Introduction
Section 11(c) of the Toxic Substances Control Act (see
ADpendix A) authorizes the Administrator to issue subpoenas
requiring the testimony of witnesses, the production of documents,
and answers to cuestions that he deems necessary to carry out
the Act. This paper provides guidance to the Regions on the
use of TSCA administrative subpoenas.
The first part of the paper will describe the various
situations which warrant the use of section 11 subpoenas as
enforcement tools. The document next sets forth the major
defenses to subpoenas which may be encountered by regional
personnel, and discusses ways to overcome such defenses.
Enforcement of subpoenas and their proper form are addressed
in the final sections.
II. When Subpoenas Should Be Used
As a general rule, subpoenas can be used whenever the
or ation sought will assist the Administrator in implementinc
the Act. There are factors, however, which reduce the number of
instances where subpoenas are appropriale.
1) Subpoenas must be not be overly broad, vague, or burden-
some, and they must be germane to a lawful subject of inquiry.
These and other limitations on Agency information requests are
discussed below as part of the section cn defenses to subpoenas.
-------
—2—
2) The Conference Report for TSCA contains the following
lancuage:
The conferees recognize that the Administrator
will have access to much information under
section 5 and section 8 of the Act. Therefore,
the conferees expect that the Administrator will
use the subpoena authority only when information
otherwise available through voluntary means or
other provisions of this Act is inadequate to
meet the Administrator’s needs under this Act.
(page 87)
This language was apparently an attempt to mollify those
souse members who disagreed with the Senate’s view that
inclusion of subpoena authority was a prerequisite to the
successful implementation of TSCA.
This “last resort” view of TSCA’s subpoena authority
prooa ly imoacts rulemaking procedures more than enforcement
activ2.ties. The broad—based information gathering which
often precedes a choice between regulatory alternatives is
oest addressed by rulemaking under sections 4, 5, and S of
TSCA. For the program offices, data gathering through rule-
making is not only an available alternative to subpoenas, it
is preferable to situation—by—situation information requests.
DE, on the other hand, conducts more focused investigations,
usually directed toward a single violation, and when informa—
zion is need d wnich has not already been assei bled under a
rule, subpoenas are generally a prooriaze.
-------
—3—
The section of the onference Report quoted above expresses
a preference for voluntary means of data gathering over more formal
information requests. Thus, enforcement personnel should always
consider simply asking for the information before drawing up a
subpoena. An informal request, however, will be inadequate in
many instances. For example, when there is a reasonable suspicion
that the evidence sought may be destroyed once it is informally
recuested, a subpoena should be issued before any other step is
taken. Enforcement personnel should also use subpoenas as a first
stec when they are unsure of the precise nature of the evidence
they are seeking, (e.g., internal memoranda relating to a parti-
cular corporate decision as opposed to financial inforrnation
In situations where EPA is not sure of what information is a’iail—
able or how reliable requested data will be, respondents should
e placed under the burden of a formal, judicially enforceable
resoons:b l tv through the use of TSCA subpoenas. In addition,
testimony of witnesses should of course be compelled through the
:ssuarice of a subpoena.
Subpoenas will also be particularly useful in two other
situations. First, data may often be sought from persons who
are not subject to the Act. Although such persons cannot be
compelled to keep records or submit information under sections
4, 5, 6, 8, 12, or 13 of the Act, data can be obtained through
the issuance of a section 11 subooer.a if such data is relevant
to a lawful ur ose of TSCA (see parts III 3 and C below)
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—4—
serona, subpoenas may be used in place of inspections.
where the Agency is interssted in reviewing a large volume of
material at the Agency rather than on—site, a subpoena may be
the more appropriate investigative tool. In addition, subpoenas
may be utilized to force respondents to collect and organize
relevant material, so that an inspector is not faced with this
task at the office or facility itself.
While it is not possible to give an exhaustive list of
all situations which warrant the issuance of a subpoena, the
above information should aid enforcement personnel in deciding
whether to invoke this authority. This decision will primarily
be influenced by how crucial the data sought is to the success-
ful prosecution of an alleged violator.
III. Defenses To Subpoenas
A. Generally
The past one hundred years have seen the courts become
increasingly receptive to the use of administrative subpoenas.
I the late nineteenth century, the federal judiciary took the
pcsition that the authority to issue subpoenas was reserved to
the courts. It was not until 1894 that the Supreme Court finally
confirmed the right of administrative agencies to issue subpoenas
1
in suoport of agency adjudications. In 1908, the Court extended
tne pe issable scope of subpoenas to include those issued for
2
investigatory purposes. As a prerequisite tc the enforcement
1. ICC v. 3ri scn , 154 U.S. 447 C1894).
2. Harriman v. FCC , 211 U.s. 407 (1908).
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—5—
of such subpoenas, however, the Court demanded that the agencies
first allege specific breaches of their authorizing statutes.
This restrictive approach towards the use of administrative
subpoenas prevailed for the next forty years despite repeated
Congressional efforts to authorize agencies to utilize investi-
gatory subpoenas even when no specific statutory violation was
alleged. The dispute was resolved by the Supreme Court’s decisions
3
in Oklahoma Press Publishing Co. v. Walling in 1946 and United
4
States V. Morton Salt in 1950. These two cases obviated the
need for agencies to show probable cause that a specific violation
had occurred. The Oklahoma Court stated that since there is no
actual search and seizure, probable cause is deemed satisfied by
a “determination that the investigation is authorized by Congress;
is for a purpose Congress can order, and the documents sought are
5
relevant to the inquiry”. In Morton Salt , the Court refined this
concept and set forth the still operative test of a subpoena’s
:alid itv:
it is sufficient if the inquiry is
within the authority of the agency, the
demand is not too indefinite, and the 6
information sought is reasonably relevant.
The following three subsections will explore the three
criteria set forth in this test.
B. The recuirement that the sub oena be within the authority
oz tne agency
The recuire ent that the inquiry be within tne authority
of the agency is actually composed of two basic elements.
3 327 U.S. 186 (1946).
4 338 U.S. 632 (1950).
5 327 U.S. 186 at 209.
6 338 U.S. 632 at 652.
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—6—
The first is the need for the investigaton to be based on
adequate statutory authority. Since the authorizing language
n section 11 of TSCA is so broad, it would require the presence
of a most wayward investigation to induce a court to declare a
subpoena ultra vires . In addition, it should be noted that the
scope of a TSCA subpoena is not limited to those persons over
whom the Agency has jurisdiction, such as chemical manufacturers,
processors, distributors, and users. Nonregulated third parties
may also be reached by subpoena if they possess information
7
relevant to the inquiry. For example, in Link V. NLRB , the
Court held that the Board could recuire a private detective
agency to reveal who had hired it to observe a union organizer.
The second element is the need for the inquiry to serve
a lawful purpose. While the motive of the nvestigation iiay
8
be nothina more than official curiosity, tne purpose of the
subDoena must be to further the administrtion of the Act.
9
Tne subpcena cannot oe used to harass the respondent. A
subpoena also cannot be used solely to aid a proposed or
10
pending criminal prosecution, although the evidence obtained
fron a subpoena issued in good faith for civil enforcement pur—
ooses can subsecuently be used in a criminal action. The burden
of showing that an ostensibly valid subpoena was issued for unlaw—
11
ful purposes is on the person alieginc abuse of process.
7 3 O F. c 4 7 (4th cit. 1964).
B United States v. Morton Salt , 338 U.S. 632, 552 (1950).
9 Snasta Minerals and C icais Co. v. SEC , 329 F.2d 285
(icith Cir. 1964). -
10 Donaldson v. United States , 400 U.S. 517 (1971).
11 United States v. Powell , 379 U.S. 48 (1964).
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—7—
Thus each subpoena must coniáiñ a brief statementof purpose,
12
clearly setting forth the objective of the inquiry. Courts have
been reluctant to halt an administrative investigation on the
basis of unlawful purpose, striking down subpoenas “only wnere
the futility of the process to uncover anything legitimate is
13
inevitable or obvious.”
C. The requirement of relevancy
Once the purpose of the subpoena has been established,
a court will require a showing that the evidence sought is
germane to the subject of the inquiry. For many years, evidence
was germane if it was “not plainly incompetent or irrelevant to
14
to any lawful purpose” of the investigation. More recently,
hcwever, most courts have adopted the standard of “reasonable
15
relevance.”
To avoid a successful motion to quash on the grcunds of
relevancy, the connection between tne demands of the subpoena
and the our ose of the investigation must be made apparent in
:rie purpose clause of the document. Conclusory allegations
16
of relevance will not be sufficient. While EPA is not
required to specify the precise use to which each piece of
12 Montsn o ines imited v. Federal Maritime Board , 295 F.2d
47 D.C. Cir. l96l); elIenIc L neE LimIted v.
Federal Maritime Board (comcaniôn1,2 5F . 2d I38
(D C. C r. i5 1).
13 Matter of Edge Ho Holdinc Corp. , 256 N.Y. 374, 381—2,
- 175 E 7, 539 (i531). —
14 Endicott Johnson Coro. v. Perkins , 317 U.S. 501, 509
[ 1543 ).
15 FTC v. Texaco, Inc. , 555 F.2d 362, 873—4, n. 23 (D.C.
Cir. I577)
16 United States v. Security Bank and Trust , 473 F.2d 638
(5th C r. 1973).
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—8—
evidence will be put, the subpoena must stab1ish a nexus
between the evidence sought and the general purpose of the
inquiry:
in the pre—complaint stage, an investigating
agency is under no obligation topropound a narrowly
focused theory of a possible future case. Accord-
ingly, the revelance o the agency’s subpoena
requests may be measured only against the general
purposes of its investigation. The district court
is not free to speculate about the possible charges
that might be included in a• future complaint, and
then to determine the relevance of the subpoena 17
requests by reference to those hypothetical charges.
D. Vague or unduly burdensome subpoenas
Administrative subpoenas which are vague or demand a
tremendous amount of information run the risk of being struck
down as unduly burdensome. Enforcement personnel must draft
their subocenas as soecifically as possible so that significant
arPounts of irrelevant information are not included within the
sco e of the requests. While answering a subpoena should not
un uiy disru t the normal course of business operations, some
18
curden will be permitted. The courts will generally be
reluctant to quasr a subpoena since the Agency cannot always
know in advance the precise information it is seeking.
The burden of proving that a subpoena is oppressive rests
19
w th the objecting party. Even if a sub oena is found to be
overly burdensome, courts will often be recep—Jve to proposals
17 FTC v. Te co , Inc. 555 F.2d 3S2, 874 (D.C. Cir.), rehearing
enlec, 4 U.S. 883 (1977).
18 Io c .
19 United States v. Tivian Laboratories, Inc. , 589 F.2d 49
tI tCir.), cert. denied , 99 S. Ct. 28a4 (1978), citing
United States v. Powell, supra , n. 11.
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—9—
which lighten the burden on a subpoenaed party by insuring that
compliance will not unduly disrupt his business. For example,
a court may allow the subpoenaed party to comply with the request
at his actual place of business. A court may also require a file
search to be made by Agency attorneys.
E. Privilege
Federal administrative law,, like the common law, recognizes
instar ces where an individual is entitled to withhold self—
incriminating or privileged information.
Just which of the common law privileges are available to
20
res ondents is not entirely clear, since courts have accepted
some and rejected other testimonial privileges. The attorrl y—
client privilege, however, stands alone as the one relationsnip
whic’r, has consistently been protected by the courts.
In order for information to be exempt from the reach of
a . adH ,niszrazive suo oena, 1) there must be an attorney—client
relationshi: in olace at the time of the communication, 2)
any c:mmun ,caticn must be made in confidence to an attorney
in his professional capacity, and 3) the communication must be
21
made for the purpose of ootaining legal advice or assistance.
22
Cor orations are entitled to this privilege as well as individuals.
note that tne third circuit has said that state—created
privileges are not recognized as a matter of federal
common law. U.S. v. Cortese , 410 F. Supp. 1330 (E.D.
Pa.), aff t d 5 G .2c 43(3 d Cir. 1976).
21 United States v. Ponder , 475 F.2d 37 (5th Cir. 1973)
22 3e11 v .Marviañd , 37 ‘U .S. 226 (1964)
-------
— 10 —
The burden of showing the applicability of the attorney—Cl:.eflt
crivilege is on the claimant.
The courts have not loo ) d as favorably upon most other
testimonial privileges. While some courts have accepted the
privileged status of the doctor—patient relationship, they
have tended to reject all other privileges, such as accountant—
client and priest—penitent.
Individual respondents to administrative subpoenas may
also avail themselves of the fifth amendment t s privilege
against self—incrimination. Corporations and associations
23
do not nave the right to invoke this privilege. In addition,
a custodian of corporate records cannot invoke the fifth amend—
24
ment, even if the records would incriminate him. An indi idual
also is barred from c1ai ing this privilege on behalf o someone
25
wn may have documents incr minatinc the claimant.
.;n individual cannot, however, ce comDelled tc disclose
the contents of his ow mind, if doinc so would be self—incri—
nazorv. Thus a w tness cannot be calIco uoon to ex la r the
ccnzents of corporate records in his possession which incriminate
26 27
him.
2 Un ted States v. White , 322 U.s. 694 (1944).
24 Ok ahoma ?ress ?Jblishing Co. v. Walling , 327 U.S. 186 (1946).
25 cuch v United States 405 U.S. 322 (1973).
6 Curc o v. un tec b ates , 344 U.S. 1l (1957).
27 Note that acdrpo atidn car.not pur osely select an individual
to answer a subpoena who car. call upcn the fifth amendment
rivilege in order to shield the cor cration from the incuiry.
The cor oracion has an affirmative oblicatior. to find someone
who does no fear that ne will incr m:nate himself by h s
answers. United States v. Kordel , 397 U.s. 1, (1970).
-------
— 11 —
Furthermore, an individual cannot be compelled to relinquish
an incriminating document in his possession which is testi—
28
rnonial in nature.
An offer of immunityr of course, will remove the cossi—
bility of a respondent incriminating himself, and thus he
may be compelled to testify. Offers of immunity must be
cleared by the Department of justice.
IV. Form And Service Of Subpoenas
Attached as Appendix B are sample subpoenas and other
auxilliarv forms. There are separate forms for compellinc
testimony and for requiring the production of documents.
The separate forms should do away with the need to state
in a cover letter to a subpoena duces tecum that the narned
-individual does not have to personally ap ear befcr the
Acency. Where botn testimony and documents are desired,
the two forms can oe ccrnbined. Since firms deliv :i c
docents demanded by a ubooeri will cfter. asc for
a Receiot of SuoDoena Response form has also
been included. Se ice should be made, where possible
by registered mail or by handing the subpoena to tne
person named therein. However, since the precise manner
by which administrative subpoenas snould be served is not
defined in TSCA and has never been defined by tne courts,
most traditional forms of service are probably acceptable.
2o sner v. United States , 425 U.S. 391 (1976).
-------
Thus the return of service form provides an opportunity to
specify the type of service made other than those listed
or. the :orm.
Wner. serving a corporation, the phrase “in his (or her)
caoac tv as” should be inserted after the name of the person
served on behalf of the company. This practice will prevent
the corporation from using the named individual to invoke
the privilege against self—incrimination. The subpoena
served on any party should be a copy, and tne original
should be retained by the issuing office. The return of
service form, when completed, should be attached to the
original subpoena. The person making service should
attem t to serve the custodian of the records sought.
If more than one person possesses the records, or :he
ustcdian is not known, a registered agent or a corporate
officer snould be served. Seference books are ava:laole
w .icn list coroorate officers. Note that tne corporate
general counsel is suallv ncr an officer, unLess n:s
title reflects a dual role, such as “vice president and
ceneral cOur.SC1’.
Tne Off ce of Enforcement will reccmmenc tc the
Office of General Counsel that the two offices cooperate
in drafting Agenc —wide rules governing procedural matters
reiat:- to suo oerLas, suon as service, motions to cuash,
and avmenr of witness fees. Develo men: of an Acencv
system for hearing inctions to guash may be particularly
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— 13 —
imDortant. When EPA has such rules in place, resoondents
CbJect ng to a subpoena may oe required to litigate their
i3t±ons to quasn osfore the Agency prlor to do ng so in
29
federal district court. EPA would then have an early
opportunit to correct any problems with the subooena,
especially those arising from objections based or.
vacueness or burdensomeness.
V. Enfcrce:nent of Subpoenas
ifl order to enforce a subpoena against an individual
who fails to comply with its demands, enforcement personnel
must first contact the Departi ent of Justice. DOJ will
represent the Agency in federal district court. The -
enfcrcenent action ma” be brought in any district where
30
1
The act .cn should take the for of an a 1icat cn f r
an order recu:r:nc o 1:ance w t tne su. ooena. Th filing
a ce—o1a:n , open:nc the doors to discovery and the cthe:
a p : of n•or ai c:v i suits, is not cessarv Cr :es rab e.
The app1 cation should briefly set forth the nature of the
invest getion, a summary of the suo oena, and a statement
of the sub oe- .aed party’s failure to ccr plv with the suboena.
In an acco pa ying er oran um in suooort of the al±cat cn.
See Ge :ne Parts Co. V. FTC , 445 F.2d 1332 (5th 2:r. i97l :
SC 2 U.S C. iS5l(o) ana (ci.
31 Goodyear T :e & Rubber Co. v. Nat:onal aoor Relations
oarc , F. z 4 , 5i (bzh r i); ETE. .. ‘ .
Quick ShoD Markets, Inc. , 526 F.2d 802 (8th C!r. 197E).
-------
— 14 —
the DOJ and EPA attorneys should provide a more detailed
description of the facts, state the basis of the court’s
jurisdiction, ex 1ain how the Morton Salt test of a subooena’s
validity is met, and emphasize that the enforcement of
administrative compulsory process is a summary proceeding.
-------
APPENDIX A
TSCA Section 11(c)
Cc) 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 infor-
mation that the Administrator deems necessary. Witnesses
shall be paid the same fees and mileage that are paid wit-
nesses in the courts of the United States. 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 ar order of the court is punishable 5 y the
court as a contempt thereof.
-------
APPENDIX B—i
SUBPOENA DUCES TECUM
UNITED STATES OF AMERICA
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
TO: (name)
(address)
To further the Environmental Protection Agency’s
investigation of ( e.g., compliance with a statutory
provision or regulation, risR posedby a chemical, etc. )
_______________ you are nêreoy required to appear berore
t ne - (RA r A.A ) in room ________, 401 M St. S.W.,
Washington, D.C., on ( month, day, and year ) , at
( time of day) , and to orlng with you the reports,
apers, document , answers to questions, and other infor-
mation reauested in the attached Specifications.
If you so desire, you may have your representative
produce, at the time and place aforesaid, the items or
information requested in the Specifications.
If you consider any of the documGnts or other infor-
mation which you submit in response to this subpoena to be
confidential business information, please mark each page
containing such confidential business information. The
mark may be the word “confidential”, or the phrase “pro-
prietary information”, or other similar marking. If you
wish to make a claim of confidentiality for this informa-
tion, you must do so at this time. Any documents or other
information not marked confidential will be available to
the public. That portion of your response to the subpoena
marked as confidential will be handled in accordance with
EPA’s public information regulations (40 CFR Part 2).
Issued under the authority of 15 U.S.C. Section 2610(c),
this _______ day of _______, 19.
United States Environmental
Protection Agency, by
( signature )
RA or AA
-------
APPENDIX B-2
SUBPOENA AD .TESTIFICANDTJM
UNITED STATES OF AMERICA
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
TO: (nar ie)
(address)
To further the Environmental Protection Agency’s
investigation of _______________________________________
________________ yôuã ë hereby r quI ed to appear
be fore —- in room ____________ , 401 i
St., S.W , Washington, C., on thè - aay _____
19 , at _____ o’clock, to testify iñ he aforementioned
matter.
Issued under the authority of 15 U.S.C. Section 2610
(c), this ________ day of - , 19.
United States Environmental
Protection Agency, by
(signature)
RA or .kA
-------
APPENDIX B-3
RETURN OF SERVICE
UNITED STATES OF AMERICA
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
I hereby certify that being a person over 18 years of
age, I served a copy of the within subpoena
( ) in person
by registered mail, return receipt requested
by leaving the copy at principal place of
(check business, which is
one)
( write in other method, such as leaving it
a dwe lling, serving registered agent o
cor oration, etc
on the person named in the subpoena on ( month, day, and year).
( signature of person making service )
(na te of person making service)
- (titleif an )
-------
APPENDIX B-4
RECEIPT OF SUaPOENA RESPONSE
UNITED STATES OF AMERICA
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
I, ( type name , certify that I received, on
behalf ofthe U.S. Environmental P rotection Agency (EPA),
the following documents from ( subpoenaed party ) on -
( month, day, and year ) in rei nse to trie PA subpoena
of ( moi th dãy, and eari
(describe submittal)
( signature )
(title)
-------
APPENDIX C MANUAL
CJI?tPT!11 12 ——
TOXIC SU T C S CO TflOL ACT
DELEC?.TIO S
12—1. InspectScns.anci SubDoenas
1. AUThOfl!TY . To designate represencaLives of the Adc inistrator:
a. To inspect any estab1ish ent, Facility, or other preniccs in
which che .ca1 substances, ixcures, or articles ContainiI g chee ical
substances or nixtures, are rnanufactured, processed, stored, or held
before or after their distribution in comricrcc; and any conv y nce
bcin used to transport chen ica1 substancc , rzixtures, or such
articles in ccnnectlon w Lh distribution in co a: 1 iercc. u y such
nspecLion shall be conducted in accordcnce with the provisthr.s of
the Toxic Subs ances Control Act Sectaor 11(a) and SccL on 11(b).
b. To requ :e by subpoena the attcndar.ce and Lestinciny of -
it ne scs cnd the pruducti on of reports, pzpcrr., doccni: , ar s .’crs
to qucst c ns , and other ntormation in accordance with the To :ic
Substa cas Control Act Section 11(c).
2. TO : o’ D:LtCATTD . Assistanr iW ini Lrctor for Enforcc ter t,
Accis:cr;: / i : traLor Lot Toxic Subs: nces, nid iz na1
i cn r tr c: .
. Li:::;c :s. T. c Assfstant ..dr’inisiratcr for Eifcirce’ •:.iL c d Li e
I ssist.. ;.d : .szra:or Lor Tcxic Subs: n a , -.ust n tify the p r —
priale Fe iona1 Ad :irastr tor prior to ta ir iny actior under th:s
• .1
0 C.1. Cn
‘!. DLLECATIcN Aur!or .1TY . The ir spoct icn uchority in (a) abc ve
i ay be rcce1e aLea; Lhe subpocnc authority ii-. (b) above i ay not be
red c1 eg : d.
‘‘ (;zV ± 1 .
7—2 (3—78
-------
STATE RELATED
GUIDANCE
)
-------
STATE RELATED
GUIDANCE
)
-------
Od7 4 P?
t% UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
4 , 10 it ’
(EC3J 8O
OFFICE OF ENFORCEMENT
MEMOR.ANDUM
SUBJECT: Guidance for Pilot TSCA Cooperative Enforcement
Agreements
TO: Enforcement Division Directors
Air & Hazardous Materials Division Directors
Surveillance & Analysis Division Directors
As I indicated to you in my memorandum of October 7,
1980,. the Office of Enforcement (OE) intends to institute a
pilot program of Federal/State cooperative enforcement
agreements under the Toxic Substances Control Act (TSCA).
The attached document contains final guidance governing
implementation of the pilot program.
In FY81, the Agency will award $1,000,000 among up to-•
five States submitting proposals for cooperative programs
designed to monitor compliance with PCB regulations. The
Agency will initially invite Connecticut, aryland, Ohio,
Michigan and California to sthmit proposals. The Regions
should work with these States to develoD the proposals.
States propose to use Federal funds to extend the range of
activities conducted with existing State environmental
protection resources, since the Agency cannot guarantee
funding beyond FY82.
We anticipate that the Regions, with assistance from
appropriate Headquarters personnel, will have pilot TSCA
agreements negotiated with the States by April 1, 1981.
If you have any questions, please contact John Martin
of my staff at 755—1075.
A 1C
A. E. Conroy I , rector
Pesticides and T Ic ubstances
Enforcement .. ision
Attachment
cc: Toxics Contacts
-------
Introduction
The Office of Enforcement (OE), under authority of Section
10 and 28 of the Toxic Substances Control Act (TSCA), will
implement a pilot program of financial assistance to States
during FT 1981 in the form of Cooperative Enforcement Agreements.
The general objectives of this program are to:
Prevent or eliminate unreasonable risks to healt
or the environment from certain chemical substa ces;
Encourage coordinated Federal/State regulatory actions
with regard to toxic substances control;
Expand compliance monItoring resources for TSCA
enforcement;
Sponsor cooperative surveillance and analytical
procedures; and
Avoid duplication of effort.
In FY81, the program will be aimed at achieving these objectives
as they relate specifically to monitoring compliance with
the PCB regulations promulgated under Section 6 of TSCA
(43 FR 7150, Feb. 17, 1978; 44 FR 31514, May 31, 19791. This
themorandum sets forth policies and procedures to be followed
by States and Regions participating in the TSCA pilot
cooperative agreement program for PCB compliance monitoring.
The Office of Enforcement, through the Pesticides and Toxic
Substances Enforcement Division (PTSED), will have approximately
$1,000,000 for this pilot program in FY81. Several States
will be selected to receive the initial pilot cooperative
agreements.
The FY81 pilot program is aimed at monitoring compliance with
TSCA PCB regulations because the Federal enforcement program
for PCB control is the broadest chemical control regulatory
program which has been implemented under TSCA. This program
will be administered jointly by participating Regional offices
and by Headquarters. If this program is successful, EPA will
consider expanding it as other chemical control regulations
are promulgated under TSCA. Specifically, EPA hopes that
the States, with EPA assistance, can play an important role
in the development of enforcement strategies and in compliance
monitoring for the Asbestos in Schools Program once that
regulation is finalized.
-------
—2—
IL. Basic Application Criteria
Before EPA will consider a proposed State program, the State
must demonstrate that it meets the following criteria:
A. Need for a Toxic Substances Control Program in the State
Each State must demonstrate that. the funds for which t.he
appLication is made will be used in a new or expandedenforce—
ment program designed to alleviate substantially a demonstrated
PCB problem. This demonstration should consist of two parts:
1. The toxic substances problem should be defined by the
extent of the manufacture, processing, and use of PCBs in the
State and the extent of exposure of humans and the environment
to PCBs.
2. The degree to which the proposed program will alleviate
the problem should be illustrated by a summary comparison of
the expected accomplishments of th proposed program with the
past accomplishments or limitations of any existing program.
B. - Ability to Implement the Program
Each application must demonstrate that there are no impediments
to the Stat ’s ability to carry out its proposed progrim. The
applicant should address the following areas as well as any
others which might pose problems:
1. Authority to. Conduct the Proposed Prograrn
A State must have enacted legislation which empowers it:
a. To enter into a cooperative agreement with EPA, and
b. To conduct the specific compliance monitoring activities
it proposes under a cooperative agreement.
Such legislation may provide for State authority to control toxic
substances and specifically PCBs. It may, however, also be phrased
in more general terms dealing, for example, with the preservation
of public health, safety, and welfare, or the cessation of a public
nuisance. EPA is interested in exploring the possibilities of
administering this program under different types of legislative
authority and will actively seek to involve States which rely upon
these different types of authority for jurisdiction over toxic
subs tances.
-------
—3—
States should. consider the preemption guidelines of TSCA
Section 18 in determining what cooperative agreement acti-
vities may be carried out under State authority. Specifically,
Section 18 preempts State authority as to chemicalsregulated
under •TSCA Section 6 with several exceptions. Preemption
occurs unless (1) the State requirement is identical to the
Federal requirement, (2) the State regulation is adopted under
the Clean Air Act or a Federal law other than TSCA, or (3)
the State regulation prohibits the use of the .Federallj regulated
chemical within the State. In addition State regulations
governing disposal of a. substance also regulated under TSCA
Section 6 are not preempted to the extent that they are identical
to or more stringent than the Federal disposal regulations.
2. Authority to Accept Federal Funds
A State which cannot implement a program under this cooperative
agreement uflhout prior authorization by its legislature to
spend Federal funds must include a statement indicating the
date on which such authorization will be obtained. Commitment
of EPA funds will b contingent on such authorization by the
State legislature.
/ 4. Access to Confidential Business Information
A State sho .ild also describe the extent of its authority to
gain access to confidential,business information, t he specific
types of data considered confidential, and the extent to which
the State may disclose such confidential business information
to EPA to enforce TSCA.
‘AiX ap ricatron s’sto-uld include anopin on of •the-State- Actorney .
General regarding the adequacy of the relevant provisions in
State law and regulations that provide these authorizations.
C. Designated Lead Agency
The EPA recognizes that a State may have a number of agencies
with separate authority for regulating toxic substances including
PCBs. Where this is the case, EPA will enter into a cooperative
agreement only with the State lead agency designated for this
purpose by the Governor. If the cooperative program for monitor-
ing compliance with PC3 regulations is successful, EPA intends
to expand the program to include compliance monitoring for
other TSCA regulations. These may include the Asbestos in
Schools regulations and other regulations under Section 6 of
TSCA. Thus, future cooperative agreements for compliance
monitoring under TSCA are likely to include activities
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—4—
related to a number of different chemical control regulations.
Therefore, •a State should consider the long term advisability
of designating a lead agency which has broad authority rather
than one which would have jurisdiction only over PCBs. A
letter from the Governor’s office must be submitted with
each application explaining why the designated agency is the
moSt appropriate State agency to head this program. The
letter should also’ provide the lead agency with authority to
contract or enter- into interagency agreements with other State
agencies, as necessary, for the performance of any enforcement
activities proposed in the application.
III. Required Proposal Elements
The completed application shall contain a proposal for
planning and evaluation of the program, an action plan
detailing activities to be conducted.by the State, and the
proposed budget over the period of the ag.reement. In addition,
the application must set forth procedures governing quality
assurance programs applicable to inspections and sampling;
the handling of confidential business information ; case 5”&’
preparation and referral to EPA; and the submission of reports
to EPA.
A. Planning and Evaluation
Each application shall describe the State’s proposal for
managing its PCB program. This management plan should
spec cally address 1) how the State established its program,
objectives and priorities and 2) how the State intends to
evaluate the effectiveness of its program.
1.- State Program Objectives and Priorities
Prior to establishing its PCB enforcement program objectives
and priorities, each State must establish a profile of PCB
use and exposure in the State. In establishing the profile
each State must consider:
o The number of each type of PCS user,
o The extent of PCB storage, disposal, and manufacture
within the State,
o The history of PCB spills and contamination within
the State, and
o The history of PCB violations within the State.
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—5—
After establishing the profile of PCB use and exposure in the
State, each lead agency should discuss how it established and
applied specific criteria and ranked areas for priority emphasis
in its coopperative PCB enforcement program. The level of
priority viii provide a. basis for allocating resources in the
State’s management plan.
In ranking it-s own priorities, each State should consider EPA
priorities and the respective capabilities of the Stac and
the EPA Regional Office to address most effectively t e various
PCB problems in the State.
The national PCB enforcement priorities and activities listed
below indicate where EPA places its emphasis in a PCB enforce— -
ment program. The resources to be spent on activities under
each priority are listed as a percentage after each heading.
a) Inspections .of the foilówing PCB U er Iftdu tries—65% -
Metals
Chemicals
Paper and Lunber
Mining
Transformer repair services
Automobiles
Textile -
Stone, Clay and Glass
Railroad
• UtUir ie.s
1) . Inspection of PCB records for completeness, discrepancies.
- - 2) Physical examination of inventories, to:
- — Verify records,
— Determine the location of equipment,
— Verify the marking of equipment and PCB
transport vehicles,
— Check for evidence and take samples of suspected
leaks and spills,
— Determine compliance with storage requirements,
— Determine compliance with PCB container requirements
b) Inspection of PCB Disposal Facilities—15Z
1) Inspection of records for completeness and
disc repancies,
2) Physical examination of inventories on hand.
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—6—
c) Spill Investigatioas—1O%
1.) Conduct investigations when PCB spills are reported,
2) Take samples of PCB contamination attributed
to spills.
d) Inspection of PCB Storage Facilities (those which are
not owned or operated by the regulated industries)—52
a’
1.) Inspection of records for completeness and discrepancies,
2) Physical examination of inventories to determine corn—
plance with storage and recordkeeping regulations.
e) Inspection of Manufacturing Facilities—5Z —— Determining
compliance w$.th PCB manufacturing restrictions by
checking, records..
In addition to these activities, EPA is also interested in
the development of programs to ensure proper handling of PCB
equipment used in commercial buildings. This may be best addressed
through an educational program alerting the management of these
types of buildings to the problems associated with PCB usage,
storage, and disposal.
The EPA’recognizes that the emphasis of a PCB enforcement
progran nay differ from State to State due to differences in
the nunber of storage facilities, disposal facilities, industries
which use PCB equipment, and the respective compliance monitoring
authorities and capabilities of EPA and the State. As a result,
tbe--amount of time .a• State wi.shes to spend in such activities
may not coincide with the national priorities as listed.
The national enforcement priorities should merely serve as
a guide for those States where all the activities listed
occur. The EPA and the State will negotiate the order to
arrive at a PCB enforcement program which best serves the
needs of both the State and EPA. While States’ are encouraged
to engage in as many activities of tl ie national program as
possible, it is not necessary for a State to undertake all
activities to receive assistance.
2. Program Evaluation
A well managed PCB cooperative enforcement program requires
periodic evaluation to ensure that limited resources are
used effectively. The goal of the evaluation process is to
identify needed program adjustments that will foster the achieve-
ment of program objectives. Such adjustments could include
shifting priorities, changing the level of compliance monitoring
activities or improving the training of enforcement staff.
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—7—
The State should develop a mechanism to evaluate its proposed
PCB program. The description of the evaluation mechanism
should address the following:
Functional Responsibility . It is essential that the State
clearly identify the person(s) responsible for performing
program evaluation.
o The State shou ld specify when program evaluations
will occur. Ginerally evaluations should be made five and
eleven months into the program. They should take
place prior to the State—EPA mid—year and end—of—year
reviews in order to permit discussion of any steps EPA
should take to improve the program as well, as any improve-
ments the State should make.
o Evaluation Methods . Each State should identify spec ific
,eyaluation tools and .describe .how it. will uèe these .tools
to evaluate various program elements. Among the evaluatioi
activities which could be included are:
— Development and analysis of report or tracking forms
to determine trends in PCB violations for use in.
evaluating program priorities.
— Review of inspection and case files to determine
the adequacy of compliance monitoring activities.
B. Action Plan
Once the State has developed its list of priority areas
under the agreement’i ,t should discuss its plan for
carrying out a balanced program to address each of these
areas during the period of the agreement. Where the nature
of the output permits, the Action Plan should contain a
nunerical summary of the outputs to be performed under the
grant agreement for each quarter. For example, the State
will summarize the number and type of PCB facility inspec-
tions to be performed for each quarter. Where the nature
of the outputs does not permit nunerical expression, a clear
narrative statemen.t of the outputs should be included.
(Appendix III contains a suggested format for reporting
the projected outputs). -
C. Proposed Budget
Each appplication must contain the State’s proposed budget
for the program. Expenditures must be supported by itemized
statements or fact sheets showing the cost for equipment,
personnel, training 1 supplies, contractual services, etc.
EPA, when funding activities under the agreement, will
give priority to ongoing operating expenses that are directly
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—8—
related to the enforcement of PCB laws, i.e., inspections,
investigations, sample analysis, travel, start—up costs for
inapectional and analytical equipment. Non—essential equip-
ment purchases will be given low priority. The requirements
of 0MB Circular A102 attachment 0 apply to all procurement
actions.
The State’s share of the totaI project COStw shall be 25%
and ay be paid indirect or allowable indirect contributions,
or by in—kind contributions. Expenses incurred by the State
for activities not specifically stated as grant commitments,
but related to PCB compliance monitoring activities, may be
credited toward the State’s contribution with Regional office
approval. These activities can either replace schedule4
commitments or be used in creatinl a new output category
specific to a particular State. An example of such an expense
may be a portion of a State program funded solely by the State
and. not. included i :the cooperative agreement.
D. Conditions df the CooDerative Agreement
PCB enforcement cooperative agreement awards will be subject
to the General Grant Regulations (40 CFR Part 30).
The applicant shall also agree to the following conditions:
1. Quality Assurance
a. DurIng all inspectibes, investigations, and sample
collections performed under the authority of
SCA, inspec ór shall adopt standard for s
and procedures as outlined in the EPA TSCA
Inspection Manual. To assure sample integrity,
EPA chain—of—custody procedures shall be adopted
during sampling, handling, shipping, storage
and. analysis of PCBs collected under Federal
law.
b. During all inspections, investigations, and sample
collections performed under the authority of State
law, State procedures and forms should be used.
During sampling, handling, shipping, storage and
analysis of PC s collected under State law, proper
chain—of—custody procedures must be adopted to assure
sample integrity. An accurate written record must
be maintained to trace the possession of each sample
from the moment of collection through its introduction
into evidence.
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—9—
c. Samples collected shall be analyzed by the State
laboratory or as specified in the application for
assistance, using EPA ipproved testing methods.
AL ]. violative samples should be verified by a check
analysis performed by a second chemist.
d. The State shall participate in the EPA Check Sample
Program. Under this program EPA shall submit a PCB
sample of known concentration to State laboratories
for analysis. EPA shall review the results obtained
and notify the State regarding EPA’s assessment and
provide assistance to the State laboratory if there
were any problems with the analysis.
e. Where the State refers a case to EPA for enforcement
action, the State may be required to participate in
the Sample Analysis Verification procedure. This
involves a veriUcacioti analysis.of.th.e sample obtained
and analyzed by the State which will serve as a basis
for the enforcement action. The State may also, at times,
desire such a check before initiating an action.
f. The EPA shall provide knovledgeable personnel for the
training of inspectors, analytical chemists and case
preparation officers in accordance with EPA practices
and procedures. The State shall avail itself of chemist
training courses as offered by EPA regarding procedures,
instrumentation and methodology. States are also
encouraged to participate in professional association
meetings such is ACAC and other professfonaltrainin
courses.
g. A State must meet certain procedural criteria for any
quality assurance (QA) program.* A State must:
i) Submit a QA Program Plan for participating State labs;
ii) Submit a QA Project Plan;
iii) Provide for a QA System Audit;
iv) Submit QA reports as determined by the Regions
and Headquarters; and
v) Express the cost of the QA Program in a laboratory as
a percentage of the total analytical costs.
*Mjfljmum QA requirements are explained more fully in Guidelines
and Specifications for Implementing Quality Assurance Requirments
for EPA Contracts and Interagency Agreements Involving nvironmental
Measurements , May 19, 1980. Copies of this document and additional
PCB—specific QA materials may be obtained from PTSED personnel.
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—10—
2. Confidential Business Information
The conditions governing access by States to confidential
business information shall be governed entirely by each
State’s own legislative authority in this area.
A State which does not have its own authority to access
data identified as confidential business data under TSCA
shall not request access to such information while coftducting
inspections under an Enforcement Agreement.
“3. Case PreDaration and Enforcement
The State shall review the quality and sufficiency of all
evidence gathered in the course of any of the inspectional,
laboratory and investigatory activities performed under the
cooperatiye agreement. •If the evidence reveals a.possible
violation of only the State’sPCBlaws, the’ State shall
pursue an appropriate remedy provided by State law. Where
such evidence reveals a possible.violation of both State
and Federal law, the State may bring appropriate enforcement
action under State law or may refer the case to EPA for
prosecution under the Federal statute. If a State does not take
action on a case within 30 days of completinj its investigation
the case shall be ieferred to EPA for action. If the State
refers the ca e to EPA, the State shall in conjunction with
the EPA RegIonal office prepare and make available testimony
and other evidence pursuant to procedures adopted by EPA.
Tbe St te si all also ptovide witnesses for public hearings
and appearances court upo-rr request of the EPA Regional office.
Where evidence reveals a possible violation of Federal law
only, the State shall immediately forward the information to
the EPA Regional office and prepare testimony and provide
witnesses as necessary.
4. State Reports
a. The State shall prepare and submit to the Regional
office quarterly reports of acconplishments under
the outputs specified in the cooperative agreement
within 15 days after the quarter ends. Failure
to submit timely reports may be grounds for the
retention of grant funds by the Regional office
or suspension or termination of the agreement.
(The State may use the format suggested in Appendix
III to report actual outputs).
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—11—
b. The State shall send a copy of the results of any
sample analysis made under the authority of TSCA
to the person from whom the sample was collected.
The State shall be relieved of this responsibility
only if the Regional office assumes it as part of
the cooperative agreement.
c. Copies of all inspecional and analytical reports
shall be submitted to the Regional office as soon
after completion as possible.
IV. Implementation of the FY1981 Grant Program
A. Summary of EPA Role
The EPA intends to determine the feasibility of developing
cooperative program with the States fo;.m nitoring compliance
witt selected prâvisi nsof TSCA As a first step, EPA will
explore a cooperative program for monitoring compliance with
the PCB regulations. In this effort, Headquarters has primary
responsibility for:
1. Developing national priorities and strategy for the
PCB enforcement program;
2. Preparing guidance forimplementing and managing
the program; -
E tabli ingruiea fortheaQard •of funds;’and
4. Making funds available to the Regions for disbursement
to the States.
Headquarters and the Regions have responsibility for:
1. Working closely with the States to develop a
complementary Federal/State program which considers
State as well as PA priorities and resources;
2. Providing review and funding approval of
applications;
3. Developing training and laboratory support for
State personnel; and
4. Conducting program evaluations.
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—12—
Each participating Region should establish a TSCA PCB Enforcement
Agreement Review Panel for the purpose of reviewing and
evaluating all PCB enforcement cooperative agreement applications
received by the Regional office. the Panel should consist of
members from the following offices:
1. Regional PCB Compliance Monitoring Program
Office;
2. Regional Enforcement Division;
3. Regional Grants Office;
4. PTSED, Grants Analysis and Information Section, and
5. PTSED, Policy Section
B. Preproposal Negotiation
The Regions should work closely with the States in preparing
the application which should clearly specify the responsibilities
of the State and of EPA. Regional offices will also constilt with
PTSED during this negotiation stage.
C. Application Submission
The formal application for assistance will consist of an Application
for Federal Assistance EPA Form No. 5700—33 and the PCB eu orce ent
p dgram Thn (“Pare IV Natratfvé Statement; Sample Format n
Appendix I). The “Part IV Narrati e Statement” should include
a discussion of the State’s eligibility, its management plan,
specific outputs, budget, and conditions of the cooperative
agreement.
EPA will normally fund only one PCB enforcement agreement per
State. It is required, therefore, that States having several
agencies with different PCB authorities submit a single proposal.
The proposal must designate one agency with authority to contract
or enter into interagency agreements with other agencies for the
performance of all necessary enforcement activities. Applications
must be submitted by March 1, 1981.
Office of Management and Budget (0MB) circular A—95 (revised)
(41 FR 2052, January 13, 1976) provides for State and area
wide clearinghouse evaluation and coordination of Federally
assisted programs and projects. All States applying for TSCA
PCB enforcement assistance shall comply with all applicable
requirements of 0MB circular A—95 pursuant to the EPA General
Grant Regulations (40 CFR Part 30).
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—13—
D. Application Review
Funding for cooperative agreements will be allocated on the
basis of the appropriateness of the State’s program plan
when compared to the criteria set forth above.
Each application will be subject to two reviews: (1) a technical
and program evaluation by the TSCA PCB Enforcement Agreement
Review Panel to determine the merit of the proposed o tputs
in view of the goals and objectives of the PCB enforcement
cooperative program and (2) an administrative evaluation by the
Regional Grants Administration Office to determine whether the
application meets the requirements of the EPA General Grant
Regulations (40 CFR Part 30).
At each stage of the evaluation, the State may be required
to provide further information or to amend the application
o satrsfy the concërns bfthe Rev iew Panel.
The Panel will evaluate the program set forth in each grant
application to determine (1) the consistency and compatibility
of the appplicarit’s objectives and expected results with EPA’s
priorities and policies in implementing a PCB enforcement program,
(2) the feasibility of achieving such objectives and the expected
results in view of the State’s existing problems, program
authority, resources and procedures, (3) the need for and
reasonableness of the cost for budgeted items, including equipment,
and (4) the reasonableness of the outputs in relation to the
re ’so irces expended.
aased on this evaluation, the Regional office should provide
written comments to the State on iti applIcatio witliin ‘30 aa
of EPA receipt of the application. -
To aid the Regions and States in negotiating and evaluating
outputs under the cooperative agreement, a list of tine factors
is provided in Appendix II.
E. Grant Award Process
PCS compliance monitoring enforcement agreements will be awarded
by the Regional office after concurrence b Headquarters. As
both the Regional offices and Headquarters gain more experience
with these program agreements, the amount of Headquarters involve-
ment will decrease. Since the Regional Grants Administration
Office is responsible for maintaining the administrative integrity
of grants awarded, it will examine the grant application to
assure that the applicable requrrements of the General Grant
Regulations are fulfilled. Cooperative agreements will be
awarded by May 1, 1981. Although agreements are normally funded
on a fiscal year basis, because this is a pilot program, the
normal funding period will be waived, and agreements should be
awarded for a period of one year.
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—14—
F. Accountability Under the Cooperative Agreement
Accounting for funds awarded under the agreement (including
receipts, State matching contributions and expenditures) must
be maintained in accordance with all applicable EPA grant
regulations and with generally accepted accounting principles.
aeadquarters suggests that the Regional Grants Administration
Office review State accounting practices and procedures prior
to award of funding to assure the State’s ability to m.aintain
appropriate records.
Funds will be paid in advance for allowable project costs in
the manner provided in 40 CFR 30.615—1.
State expenditures under the agreement must follow cost
categories (i.e., budget line item or by program element)
4stablished In the original agreement.
The State must maintain support vouchers and records
of expenditures to show application of funds to activities
for which the agreement was intended. Such records will be
subject to inspection and audit by the Regional EPA Audit
office, other offices of EPA or by other authorized agencies.
G. Training
Training under this pr gram will be conducted by the EPA
Regional office with support from EPA Headquarters. Training
w.Lli. cpnaist -of instruction in- inspecti-onal- and- sample col-lectio-u: -
techniques, sample analysis, case preparation, and handlLn r,f 77i7
confidential business information claims . Training will take
place prior to the funding period when possible and will con-
sist of both classroom and on—the—job training. If new personnel
are being hired to carry out this program, training should
take place within 60 days after the signing of the cooperative
agreement. Training materials will Include the TSCA Inspection
Manual and sample analysis protocols. Headquarters will make
these materials available to the Regions by March and will
meet with the RegIons to discuss the specifics of training
program development.
H. Program Evaluation
Program evaluation is an essential ingredient of the management
and administration of the grant program. Regional personnel
should meet with appropriate State officials on a quarterly
basis to review and evaluate the grant program from both
a State and regional point of view. If quarterly visits are
not possible due to travel restrictions or other constraints,
at least two visits per year must be made. Headquarters will
participate in the mid—year and end—of—year review. Mid—year
and end—of—year reviews must be conducted within 30 days
of the end of the quarter.
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—15—
During the mid—year and end—of—year evaluation meeting the
review team should: -
1. Compare the actual accomplishments with the proposed
outputs in the grant agreement;
2. Review sample collection documents, inspection reports,
investigation reports and reports of analysis for
accuracy and quality;
3. Review accounting procedures for accuracy and complete-
ness; and
4. Discuss any problems or unusual developments
affecting grant performance.
If thereview indicates .deficiencies-in any.of the above areas,
the review team should be prepared to offer iuggestionsand
guidance such as additional inspector or chemist training,
renegotiation of grant outputs, etc.
The end—of—year review should also include an assessment Qf
the planning and management of the program at the State and
Federal levels. This assessment should take into account
the data collected, trends suggested by the data, rates of
compliance as noted from insp.ectiooal reports, the effectiveness
of th program in its present state, appropriateness of priorities
based on compliance monitoring results, quality of the program,.
and any.ctiange whi.ch. could be mad.a •iu the pr gram’to -increase
its effectiveness. Such a critical assessment is especially
crucial in a pilot program of this type.
The Regional office shall prepare a written report of each
evaluation and send a copy to the State within 30 days of the
evaluation. The report should include a discussion of the
basis for, and possible solutions to, any deficiencies found
in the program. The State shall be allowed 15 working days
from the date of receipt of the report to concur with or
respond to the evaluation report. A copy of the Regional
evaluation report and the State’s response will, be sent to
Eeadquarters by the Region.
I. State Reporting
The PCB enforcement agreement plan must provide for the
State to prepare and submit to the Regional office all
information required. Failure to submit timely reports may
be grounds for the retention of funds by the Regional Office
or suspension or termination of the agreement.
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16—
7. Regional Reporting
The Regions must forward copies of all quarterly, mid—year
and annual reports to PTSED for review. PTSED should
also be kept informed of any problem areas or serious
deficiencies that develop within a State program.
Modification, Suspension or Termination of the Agreement
The provisions and funding of the agreement must be modified
by EPA and the Sta;e if it is found that actual. accomplishments
differ significantly from the planned accomplishments. These
changes may include, but are not limited to, changes in the
outputs, changes in the date of performance of specific outputs,
or changes in the budget for the period of the agreement. Changes
in the agreement are effective only upon the execution of a
written amendment. If performance by the State does not improve
after modification of the agreement, steps may be taken by EPA
to suspend or terminate the agreement.
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APPENDIX I
Part IV Narrative Stateinent Sample Format
I. State Profile
A. Basic Criteria
The State must provide a narrative statement addressing the following
areas as discussed in the guidance:
1. Need for a Program
2. Ability to Implement the Program
a. Authority to Conduct the Proposed Program,
b. Authority to Accept Federal Funds,
c. Access to Confidential Business Information.
3. Designated Lead Agency
B. Personnel Summary
Direc, tor/Administrator
Supervisory (Inspt/Chem.)
Inspectional
Chemist
Workyears cur-
rently comitted
to PCB compli-
ance monitoring
and enforcement
Projected workyears
under federally
funded PCB complianc
monitoring and
enforcement program
Lab Teche
Clerical
Legal
II ,
Proposed Statement of Work
The Statement of Work should explain the overall objectives of the
proposal, a general plan for achieving these objectives, and how
the grant funds are to be utilized. The following areas must be
addressed in the proposal:
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Appendix I cont.
A. Planning and Evaluation
B. Action Plan
C. Proposed Budget
III. Conditions of the Cooperative Agreement
This section should indicate that PCB enforcment agreeQe t awards
are subject to the General Grant Regulations in 40 CFR Part 30.
In addition this section shall contain the State’s agreement to
conditions governing the following areas as discussed in the
guidance:
A. Quality Assurance
B. Handling of Confidential Business Information
C. Case Preparaqion. and Enforcement
D. State Reporting
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AppENDIX II
TINE FACTORS
Activity Workhours to complete
Typical inspection 8
including collection
âf 3—6 samples.
Preparation and ship— 4
ment of samples (per
inspection)
Preparation of pre— 16
lithinary Inspection
Report
rreparacion or zi.nai 12
Field and Analysis
Re orts
Sample Analysis
TIME REQUIRED TO PERFORM AN ANALYSIS FOR PCBs ON ONE SAMPLE
OF EACH TYPE OF SUBSTANCE.
Transformer Oils 10 hrs
Silicon Ojis - 12 hrs
Hydraulic Fluids 15 rs
Soil/Sludge/Selinent 32 hrs
Water. 30. tirs
Fish 42 tire
Vegetation 33 hrs
FOR ADDITIONAL SAMPLES OF THE SAME TYPE, BEING ANALYZED
AT THE SAME TIME, MULTIPLY THE TIME REQUIRED TO ANALYZE ONE
SAMPLE
NUMBER OF SAMPLES MULTIPLICATION FACTOR
2 1.06
3 1.12
4 1.18
5 1.24
6 1.5
7 1.75
8 2.36
9 2.42
10 2.48
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Appendix IL cont.
PTSED has compiled the above time factors to assist the Regions
and States in negotiating and evaluating PCB cooperative enforcement
agreements. These time factors are based on the Agency’s experience
in PCB inspection and analytical work done by both Regional staff
and contractors. These factors will be subject to review and
adjustment as the State program is implemented and better infor-
mation becomes available.
The above figures include all inspectional or analytic ’al time spent
to complete an activity, including supervisory time, travel time,
preparation time, office work, etc. The Regions must remember that
the times given are large enough to include the prorated time for
administrative type activities of inspectors and chemists. When
using these figur es to evaluate a grant- application, -reasonable
administrative, case preparation, legal and clerical support
time can be charged in addition to .inspectional and analytical.
time.
These time and cost factors should be used as a guide in negotiating
and evaluating grant applications. The number of inspections,
samples, analyses, etc., multiplied by the time factors should
equal the approximate number of work hours required under the grant.
To ensure equal treatment of all States, it should be assumed
that a normal work year consists of 1800 work hours after allowing
for leave and holidays.
Deviations from these time factors can be expected due to differenc .
in travel tifle,. local procedures, etc. Rowever, work hours grossly.
in excess of these computed levels muse noi be permitted. Significant
differences between the amount requested and the anount conputed
must be. justified, e.g., need for extensive travel time, or t.he
applicant should be directed to either reduce the requested funding
level or increase the output commitments. If an applicant’s
comnitments are in excess of the computations the Regional office
must assure itself that the quality of work is not suffering at the
expense of quantity of outputs.
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App N ) III
Prolected (Actual) Outputs Under TSCA
Enforcement Grant
Activity
1st Quarter
2nd Quarter I 3rd Quarter
4th Quarter
Total
Insp.
ISamp
map. I Samp
Inup. I
Satap
I.
.:
J
map. I Samp
I
hasp. Samp
.
1. PCB User Industry Inspect ionu
Automobiles
..
.
:
.
.
1
Chemicals
.
.
I
Metals
.1
•
1
.
Mining
I
I
.
I
Paper and Lumber
Railroads
I ‘ 1
I I_______
.
Stone, Clay and Class I
I ••I
I
—
Textiles I
I
____________
1 1
Transformer repair Services
I -
I
I
:
Utilities I I -
-
I
I
2. FCB Disposal Facilities
I I
.
.
Inspections I I
• i
3. PCR Storage Investigations I______
:
,
4. PCR Storage Facilities
Inspections
‘
5. PCB Manufacturing
Facilities inanertions
I
I.
I
I
I
I I
I I
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UNII .) iAi. rr jI a i’ si *
I WASHU4GTON. D.C. 20460
. .
b
CFF1CE OF EKFO :
11 E ’ U ND U M
SU3JECT: Supple er.tal Guidance Procedures for State Inspectors
Acting Under the Authority of TSCA Section 11
TO: ‘Enforcement Di-vision Directors
Air & Hazardous Materials Division Directors_
Pesticides Branch Chiefs
Region ‘: V & IX
. Introduction
The Pesticides and Toxic Substances Enforcement Dfvisi T Z )
is administering a Pilot Cocperativc- Enforcement Program urid r
the Toxic Substances Control Act (ISCA). Last December, PTSU;
sent guidance to the egicns cr use in soliciting grant prc L:2. s
from States which expressed I rest in participating in thIs
iict ogram. The dre : ap iicati ns indicate that nost St .r
concuct progr n cc .pliar.ce oni:oring uncer Federal raz. :
tn n .State authority. Therofor ., this Office has determir.e
ccie ieritai guicar.ce is necessary regar.ding the insr eczicr • •
ce res to be followed by State inspectors. The purpos-e o t.
g i ar:e is to e:ail ir;soection procedures for State insp c:c
actL under the authority of Section 11 of TSCA.
II. Backaround
The e ress langua e of Section 11, states that oec:i-
activities under ISCA era not i it d to EPA persc . . An .’
dul ’ design ted repr en:ativ ’ o the Administrator y s:
i ses where cher’ii al suL tances are manufactured,
tcred, or held, (Section 11(a)). Pursuant to Section ll(a’.
th .Adminjztr tor may ciesio i te State inspectors as.rr scit . v
or purpose cf c ciu:tir.; 2C3 cD’rpiiancE act vit1Es.
section aria Sccton 2 authori:e the orcpcsed
cooperative enforcement program.
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The Office of Enforcement (OE) has decided that State
r’specti rs, while acting as representatives of the Administ:ator,
shall not have access to ISCA Confidential Business Information
(CEi). This decision is based, in part, on Section 14 of ISCA
\- hi:h limIts a cess to car. Even though Section 14 allows
;epr sentatives of the A mintstrator- to ob-tain CBI, the Age c.y
is concerned that State Inspectors might not be subje t to
criminal penalties for wrongful disclosure under Section 14(d).
Accordingly, State inspectors are not authorized to obtain
ISCA cBI under the current Pilot Cooperative Enforcement Program.
This limitation applies only to the current program, and the
Agency reserves the right to determine that State Inspectors
ray obtain CBI in other future programs.
UI. Confidential Business Information
Discussion
Uhenever the Agency makes an oral or written request for
information from a business under TSCA, the business has the
ricnt to claim the information as CBI (40 CFR §2.203(a)).
7h p raze “CBi” includes the concept of trade secrets.
Under this concept, a business has the right to limit use or
disclosure of trade secrets so that the business may obtain
Cr retain business advantages arising from its rights in ti e
infcrT ation (40 CFP. §2.201(e)). CEL status inimediate y
attaches to the information once it is claimed and certified
that the information meets the requIrements for CBI as shown
th CBI otfce. 2 The Agency implements special procedures
to safecuard against disclosure of CBI to unauthorized OerSCr S.
: the present PC3 Cooperat ve Enrorcement Program, S:ate
inspectors acting under the authority of Section 11 are not
thor z access to- 3I---—T-h-e—sc -c-esi_or the program snou d
nct e adversely affected because of this limitation, however.
Fe C3i claims arc- anticipated during PCB inspections since
th i if rmation collected will not usually yield commercial
advantaces to competitors. Experience with contract in p!ctcrs
indicates few claims are made. Consequently, the Agency
does not anticipate that the lack of C31 authority will
n:erfere with thc- majority of State inspections.
Additionally, State inspections in this Pilot Co perazive
Enforcement Program may have dual inspection authority granted
by both ISCA Section il and also under relevant State legis—
lation. In such cases, a State inspector may chocse to
conduct the fnspection under State law. When conducting an
inspection under State law, the inspector is not barred by
2. The General Counsel is the designated agent to institute an
intra-Agency challenge to a CBI claim (40 CFR §2.207(a)).
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TSCA from col1 ting C31 and may ccilect any information State
i w authorizes nir,i to obtain. The inspection procedures
eezi1ed In the following parts of this memo do not apply to
tateinspec:orE act1ng.und r_5t te PCBi w _
I oectiori Procedures
The ISCA Inspection Manual, (Volume 1, January 1980,
hereinafter, the “Manuar’), explains the procedures that
Agency inspectors follow during enforcement inspections.
These procedures are, with certain modifications outlined
below, binding upon State inspectors conducting inspections
under Section ii. (Headcuarters wii provide the Regi ns
with a sufficient nunloer of Manuals to distribute to the
State inspectors.)
Prior to the inspection, the State should telephone the
facility which Is targeted for inspection. State personnel
should set a specific time and date for an inspection. During
the conversatior., the facility representative should be asked
to dc-signate and ensure the presence of a responsible company
official who can supply the inspector with requested information,
and to guide him during the inspection and make CBI claims.
A) Entry
Under S cticn 11, the inspector is required to .present
he o r.er, o arator, or agent in charge of the facility with:
° Proper credentials identifying the holder as a duly
authorizec representative of the EPA Administrator; and
° A written notice of inspectjon.
dditior.al entry requirements which uzt be followed are
found in Chap:er of the Manual. Since State inspectors acting
under Section H are not authorizec access tO CS. !. they must
follow additional special steps. The additional steps vary
depending upon the availcoility of a facility official who has
authority t a e CS.! claims. The Manual should be disregarded
tc the extent that its procedures for CS! differ from what appears
hel ow.
B) Ooeninc Conference
The Inspector must present a TSCA Znspection Confidentiality
Notice (in Manual Chapter 6, hereinafter, Notice) to the facility
owner or agent in charge during the opening conference. This
Notice inforns facility officials of their right to claim as CBI
any information (documents, physical samples, or other material)
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collected by the inspector which meet the cr:eria shown on the
Notice, (detailed below). The inspector musi ascertain whether
the facility official to whom the Notice was given has the
authority to make CBI claims f ’ r th company. The facility
official-s sigr!ature—nlust beobtalned a-t theappr pri te plae
on the 1otice certifying that he does or does not have such
authority.
1. Official Is Available
If the official has authority to make CBI claims, the
next step for the inspector is to outline inspection plans
with the facility official to allow the official to assert
any C3I claimS. The inspector must indicate what records or
samples need to be. seen to document comp-liance with the PCB
rule. The offlc.ial should be informed that to c.la-lm any
information as C8I requires him to certify the following
for each piece claimed:
a. Your company has taken measures to protect the
confidentiality of the information and it intends
to continue to tale such measures.
b. The information is not, and has not been, reasonably
obtairrabie without your company’s con.sent by other
persons (oth.er than governmental bodies) by use of
legitimate means (othe - than discovery based on a
showing- of special need in a judicial or quasi—
judicial proceeding).
c. The information is not publicly available elsewhere.
d. Disclosure of th-e 4nfcrmat-4en--w u4 -d—c-ause—s-ubstantial
ha 1 m to your coITipany-’s-cornpetitiv position;—
The above li :ed criteria for CBI appear on the Notice
presented to the facility official. If the facility official
chooses not to make a C3 1 claim, the inspection may proceed.
Alternati ely, the facility official may i ake a CS! claim.
This is done by completing the DeclaratIon of Conficential
Busin3ss Information form (hereinafter DCBI). As earlier
ncted, each item claimed as C31 must meet all four of the
criteria cn the Notice. The inspector must not argue with
plant officials who decide to make CS! claims. The role of
the Inspector Is only to educate the facility official about
the CS! requirements. The inspector must regard the decision
of the facility official as final.
After a CBI claim Is made, the inspector must determine
if the inspection objectiyes can still be met. This decision
s guided by the scope ofthe CBI claim. For example, a facility
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orficial might claim as CBI data which reflects the company’s
otal volume of PCB disposal. Under this circumstance, the
•nspector should_r .gy t that the ofjl.cial send this documentary
evidence to the EPA regional office following usual CBI procedures:
a. Each page of each document should be stamped
“Confidential Business In formation.”
•b. A dated cover memo should accompany the submission
indicating that the information is part of’ a State
conducted Inspection under TSCA and date of inipection.
c. The documents should be placed Inside an envelope also
marked as “Confidential Business Information.” This
envelope should .be placed inside a plain envelope and
mailed immediately to the Document Control Officer In
the appropriate Regional Office.
The inspection may, of course, continue as to other documents
for which a CBI claim is not asserted. Likewise, the inspector
may collect samples which document compliance with the ?CB rule.
Inspectors should consult Chapter 3 of the Man jal to assure that
all collected records and samples are properly identified. The
admissibility in an enforcement action of this evidence depends
upon these procedures being followed.
At the closing conference, the inspector must issue a
.eceipt for all collected samples and documents. Any documentary
evidence which the facility sends to the Region should also
be acknowledged on the receipt. The purpose of this receipt
is to protect the Agency by showing that facility officials
knew wnat documents andsamples
conference also provides an opportunity for answering questions
which may develop during the course of the inspection.
2. Official is Unavailable
After presenting his credentials, the inspector may find
that the facility official to whom the Notice was given does
not have the authority to make CSi cl ims for the co!npany.
Although the facility owner and the agent in charge •are assumed
to have the authority to make CS! claims, it is also possible
that these officials will want to consult their attorneys
(or superiors in the case of agents in charge) regarding
this issue. The following alternatives exist for dealing
with these problems.
If no authorized officials are Immediately available,
the State Inspector must temporarily terminate the Inspection.
fore leaving the facility,the inspector should confirm the
ntity of officials who are responsible fbr CS! claims.
e State should then contact, by letter, the responsible
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official to determine If a CBI cl.aim is going to be made.
I. the responsible official does not make a CBI claim, the
inspection c n be re—scheduled and conducted by the State.
Alterna l ifthe..company .ffictaJ._a..sserts a CBI cia-i-rn—
in his response to the letter, the State inspectors may re-schedule
the inspection only if the inspection can be conducted so
:nat there is no contact with CBI. If this limitation would
thwart the purpose of the inspection, the case should be
referred to the Region. The Agency expects that very few
companies will make CBI claims in the context of these PCB
inspections. However, it is necessary that these procedures
be fo1l wed to ensure that companies have a rneaningfal oppor-
tunity to assert CBI claims
IV. Summary
A) Where the State inspector conducts the inspection
under State authority:
1) State procedures control;
2) There are no CBI limits beyond those of State law; and
3) Enforcement action is pursued under State law.
) Where the State inspector conducts the inspection under
Federal authority (Section 11, TSCA):
1) •Federal procedures must be followed (a s detailed in
this memo);
•_ )._CBI limit.. tlons..app1y.;
3) Enforcement is pursued under Federal law by the
Region.
If you have any questions regarding these procedures, please
contact John Martin of my staff at 202—755—0935.
1 rector
Substances
vision
A. E. Con
Pesticides a
Enforcement
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ADDITIONAL SOURCES
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ADDITIONAL SOURCES
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