<pubnumber>722B85002</pubnumber>
<title>Toxic Substances Control Act: Compliance/Enforcement 
Guidance
Manual: Policy Compendium: Part II</title>
<pages>278</pages>
<pubyear>1985</pubyear>
<provider>NEPIS</provider>
<access>online</access>
<origin>hardcopy</origin>
<author></author>
<publisher></publisher>
<subject></subject>
<abstract></abstract>
<operator>leidos</operator>
<scandate>07/27/21</scandate>
<type>single page tiff</type>
<keyword></keyword>
v>EPA Toxic Substances Control Act
Compliance/Enforcement
Guidance Manual
Policy Compendium
U.S. Environmental Protection Agency
Washington DC 20460
Issued by
Pesticides and Toxic Substances
Compliance Monitoring Staff
and
Office of Enforcement and Compliance Monitoring
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United States Pesticides and
Environmental Protection Toxic Substances
Agency Enforcement Division
Enforcement Facts
and Strategy
PCB
Interim Measures Program
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Enforcement Facts and Strategy
Polychlorinated Biphenyls (PCBs)
Interim Measures Program
August, 1981
C ontents
Page
Background 1
Regulated Community 2
Summary of Requirements 2
Violations 4
Enforcement Objectives 5
Compliance Monitoring 6
Interagency Cooperation 10
Voluntary Compliance/Awareness Effort 1]
Allocation of Responsibilities 12
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5ac <grounci
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 port ion 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
illegal.
Because the effect of this decision would have seriously disrupted
the distribution of electricity in this country, representatives
of the electric utilities, chemical industry, Environmenta1
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,
leaving provisions of the PCB rule that the Court's decision
had set aside still in effect for those who comply with the
Interim" 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-contaminated 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 visually 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 other 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 3,500 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 PCB-contarainated 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
PC3s on any portion of its external surface.
"Moderate leak" means any leak which results in any quantity of
PC'tJs rienning off or about to run off the external surface of the
P C 3 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
"^1 u i d on or around the PCB unit. Such inspection should not require
shutdown 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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PCB Units in Food and Feed Facilities
For PCS 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, upon 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.
*N0TE: 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 activities 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 products is subject to the quarterly inspection
requirements for all PCB transformers. .
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A11 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.
Vi olati ons
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 Section 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 Sect ion 6(e) of
TSCA. The following is a list of the various ways in which the
requirements of the Interim Measures Program can be violated.
° Failure 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. PCB and PCB-contamir.ated
transformers are subject to the weekly inspection requirements
if an exposure risk 1s 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 1n records whether leaks are moderate.
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0 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 moderate
leak or cleaning the external surface of the PC8 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 discovery (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 informati on in the report to EPA.
o Failure to maintain requi red records. This category includes:
o Maintaining no records,
o Maintaining incomplete records.
o Not initiating maintenance of records on the effective
date of the Interim Measures Program^
0 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 PCBs 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 imp roper
disposal and could resuit 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 PCBs 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 program for enforcement of the
PCB rule. These inspections are 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
Ito 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 will 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, 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.
Compliance Monitoring
^mpliance monitoring for the Interim Measures Program is divided
hto two parts: a routine compliance monitoring program consisting
of inspections conducted across the range of industrial categories
subject to the requirements, and a records review effort directed
specifically at the,«ut1lity and food and feed industries.
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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 com-
pliance with the PCB rule. Because of limited Agency resources
and the need to move forward with inspections in other segments
of the 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, complianee 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-jfor 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 faci1ity(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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If a utility company fails 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. Consequently, 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; an-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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since the weekly inspection requirement has been in
effect for several months. (The first weekly inspection should
have been completed by May 18» 1981.)
It should be noted that a food and fee'd facility may respond
that it does not have any transformers subject to the re-
quirements. Only PCB and PCB-contaminated 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.
° 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 or other deficiencies, the company may
be selected for further investigation, possibly including
an on-site inspection.
o £valuation
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 summaries will 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 ncluded.
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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Interagency Cooperation
The Food and Drug Administration (FDA) and the U.S. Department
of Agriculture's Food Safety and Quality Service (FSQS) 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 Reports. EPA will be receiving reports of moderate
PCB leaks at food and feed facilities. The Regions should set
up 3 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
f ac i1i ty.
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 other 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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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 Compliance/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 Assistance
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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,Allocation c" Res Don s 1 p i 1 11 i e"s
Headquarters (PTSED)
Regions
]. Awareness Effort
1. Awa renes s Effort
PTSED will work with Office of
Industry 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. Interaaency Cooperation
Regions may perform additional
educational activities.
2. Interagency Cooperation
PTSED will provide printed
materials for use in briefing
other agency staff. (PSB)
PTSED will provide assistance
and guidance material, as needed,
to foster interagency cooperation.
(CMB)
3. Compliance Monitoring
Regions will brief other agency
personnel on the Interim"Measures
Program.
Regions will obtain lists of
food and feed facilities
from FHA and FSOS.
Regions will set up a mechanism
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
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 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.
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Headquarters (PTSED)'
Reqions
PTSED will provide policy
assistance if needed for the
issuance of subpoenas. (PSB)
PTSED will provide guidance
for the review of records
submissions. (CMB)
3b. Reports of Moderate Leaks
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
3c. Routine Compliance Monitoring
Regions will designate an
individual to receive reports of
moderate leaks from food and feed
faci1iti es .
Regions will evaluate all reports
to determine if an Agency response
is needed. Response can range from
a fol 1 owap- telephone call, to
alerting food quality agencies, to
an on-site inspection.
3c. Routine Compliance Monitor-?™
PTSED will prepare inspection
procedures for compliance
monitoring for the Interim
Measures Program. (CMB)
4. Case Development
Regions will include procedures
to determine compliance with the
Interim Measures Program in their
routine PCB rule inspections.
4. Case Development
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 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 PTSED concurrence.
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Headquarters (PTSED)
Regi ons
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)
PTSED will prepare a national
summary. {CDLB)
PTSED will modify the enforcement
strategy and—procedures as
Reeded. (PSB)
Regions will prepare summaries
of responses to the records
requests and compliance data,
and forward to PTSED. Infor-
mation from routine compliance
monitoring may be included.
The first summaries should be
submitted at the end of the third
quarter of FY 1 982.
PTSED--Pesticides and Toxic Substances Enforcement Division
PSB--Poiicy and Strategy Branch
CMB--Compliance Monitoring Branch
CDLB--Case Development and Legal Branch
0TS--0ffice of Toxic Substances
FDA--Food and Drug Administration
FSQS--Food Safety and Quality Service
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D C. 20460
SEP ! 4 198
MEMORANDUM
SUBJECT: Civil Penalty Cases Involving Use of PCBs in Hydraulic Systems
Several administrative PCS 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.jV 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 sold'to
the company for its hydraulic machines;
1/ The phrase "ever contained PCBs" Is interpreted to mean ever contained
PCBs greater than 50 ppm in accordance with 5761.1(b) — "Unless it is other
wise specifically provided, the terms PCB and PCBs are used in this rule
to refer to any chemical substances that contain 50 ppm (on a dry weight
basis) or greater of PCBs..."
TO:
Enforcement Division Directors
Air and Hazardous Materials Division Directors
Surveillance and Analysis Division Directors
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- An oral statement was made by company representative!s) that PCB
fluid had been used 1n the hydraulic systems at one time; or
- Information 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 nunfcer
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 1s found 1n 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) 1s 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 containment 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 improper 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 containment, however, a storage charge may be appropriate.
B. When Absorbent Material Containing PCBs is Found in Trenches or Sumne
Near the Machines 21
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 PCB since the concentration is less than 50 nnm '
because of dilution [see §761.1(b)].
image:
-3-
C* When PCB Debris Has Been Removed from the Trenches or Sumps
The question of whether improper disposal of PCBs has occurred 1s again
raised In situations where the company practice is to collect PCB debris
fran the trenches or sumps to be discarded. If sampled debris 1s found to
contain greater than 50 ppra PCBs and is observed In a dumpster or containers
awaiting p1ck-up by a trash collector, a disposal charge 1s warranted.
Without a sample, 1t 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 1s discouraged. Although a charge for Improper
disposal is not recommended without a sample, a charge for Improper 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 Marcle Kleban (8-755-7999) of my staff.
Pes ces
Enforcement\^Jvi si on
image:
U.-irea States Pesticices and
Environmental Protection Toxic Substances
^aancv Enforcement Division
*>EPA Enforcement
and Strategy
Premanufacture
Notification
(PMN)
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Premanufacture
Notification (PMIM)
Concents Page
PART ONE: REQUIREMENTS AND GENERAL' INFORMATION
Section 5: Premanufacture Notification
Section 5 Enforcement Strategy Overview
Regulated Industries 1-2
Exemptions
Substances Excluded from Section 3 Review ^.3
Requirements of the Section 5 Program 1-4
Regulatory Options Under Section 5 1.4
Timetable 1-7
Interim Enforcement Policy l_g
Enforcement 1-8
Objectives 1-8
Voluntary Compliance 1-8
Types of Violations 1-9
Bases for Targeting Inspection* 1-12
Violation Detection Methods 1-13
Remedies 1-14
PART TWO; OPERATIONAL CONSIDERATIONS AND PRIORITIES
Priorities
2-1
Administrative Considerations 2-2
Allocation of Responsibilities 2-2
Program Integration 2-3
Enforcement Strategy
Section S:
Premanufacture Notification
August, 1 980
image:
Foreword
The final enforcement strategy consists of three parts. Part I
contains general introductory material. Part II contains
general operational concerns such as establishing enforcement
priorities and discussing the allocation of responsibilities.
Part III contains program implementation materials and consists
of three independent documents. These three documents are: (1)
the Section 5 Inspectional Procedures which provide detailed
inspection guidance to field staff members performing Section 5
inspections; (2) the Section 5 Neutral Administrative
Inspection Scheme which presents a prioritized selection scheme
for targeting Section 5 inspections; and (3) the Section 5
Penalty Policy Guidance which adapts the general TSCA Penalty
Policy to the specific needs of Section 5. Each of these three
documents can be detached and used separately by the
appropriate Agency units.
Page numbering is organized by Part. The first digit of the
page number refers to the Part, the second to the specific page
within that Part (e.g., page 3-12 refers to page 12 in Part
3).
Enforcement Strategy
Section 5:
Premanufacrure Notification
ii
August, 1 980
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PART THREE: PROGRAM IMPLEMENTATION MATERIALS
Section 5 Inspection 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 3-13
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 Background of the
Section 5 Penalty Policy 3-35
Enforcement Strategy
Section 5:
Premanufacture Notification
August, 1 980
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Part One
Requirements
and General Information
Contents -¦ Page
Section 5: Pramantifacttira Notification 1-1
Section 5 Enforcement StraE»^v Overview 1-1
Regulated Industries, 1~2
Exemptions ... - - - -
Substances Excluded from Section 5 Review
Requirements of the Section 5 Program
Regulatory Options Under Section 5
Timetable
Interim Enforcement Policy
Enforcement j_g
Objectives
Voluntary Compliance l_g
Types of Violations l_g
Bases for Targeting Inspections 1-12
Violation Detection Methods 1-13
Remedies 1-14
Enforcement Strategy
Section 5:
Premanufactura Notification
August, 1980
image:
?3 n Cne
1 Requirements and General Information
Section 5: Premanufacture Notification
Section S of the Toxic Substances Control Act (TSCA) and the
Premanufacture Notification (PMN) regulations proposed under
Section 5 of TSCA require chemical manufacturers, processors,
importers, and exporters* to notify EPA before manufacturing
processing, importing or exporting a new TSCA chemical (44 FH.
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 TSCA chemical is a substance that (1) does not appear in
the Inventory of Existing Chemical Substances published by EPA
under Section 8(b) of TSCA, (2) is not specifically excluded
from TSCA mandate (pesticides, firearms, ammunition, food, food
additives, drugs, cosmetics, devices, tobacco, tobacco
products, asd 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 to 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 iad.ustr.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 Strategy Overview
Section 5 and the proposed PMN Regulations require chemical
manufacturers, processors, importers and exporters to notify
EPA prior to the manufacture, processing, importation or
exportation of a new TSCA substance. Section 5 then allows EPA
to take regulatory action if any phase of the substance's
* While 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.
Enforcement Strategy
Section 5:
Premanufacture Notification
1-1
August, 1 S30
image:
Part One
1 Requirements and General Information
manufacture, processing, distribution in commerce, use, or
disposal 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 OE1s 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 Headquarters 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 the. PMN
requirements through the improper commercial 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 ia
the United States.
There are no accurate figures available regarding the number of
importers and exporters subject to the Sect'ion 5 requirements.
According to the American Importers Association, there are at
least 1,200 brokers and up to 35 ,000 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.
Enforcement Strategy
Section 5:
Premanufacture Notification
1-2
August, 1 980
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--arr One
1 Requirements and General Information
Exeaocions
EPA. may, upon application, exempt from some or all of the PMN
requirements a manufacturer, processor, importer, or exporter
of any of the following:
• A new substance where the test data is being
developed by another establishment,
• A new substance that is being test marketed,
« A new substance Chat 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.
Enforcement Strategy
Section S:
Premanufacture Notification
1-3
August, 1 930
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Part One
1 Requirements and General Information
Requirement a of the Section 5 Program
The proposed rules provide that notice can be accomplished by
the submission of a completed Premanufacture Notice 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 Potions Pnder Section 5
After OPTS receives a Section 5 notice, it has, by statute, 90
days for review. (For good cause the review period can be
extended 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). is authorised under Section 5(e) to issue a
proposed order or apply directly to a U.S. District Court for
an injunction to prohibit or limit the manufacture, processing,
distribution in commerce, 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 unreasonable 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
Enforcement Strategy
Section 5:
Premanufacture Notification
1-4
August. 1 980
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=an One
T flaquiramants and Genera/ Information
becomes final and is enforceable once the PMN 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) if
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 may issue a
proposed order or apply directly to a U.S. District Court for
an injunction to prohibit the manufacture, processing, or
distribution of the substance. (This is in contrast to Section
5(e) where the Agency may 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 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 objecti-ons are made within, the 30 days, the proposed order
becomes final and is enforceable once the PMN review period
expires (usually about 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 PMN" 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 amount of the substance' which may be
manufactured, processed, or distributed in commerce,
• Prohibit or limit the manufacture, processing, or
distribution in commerce- 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,
Enforcement Strategy
Section 5:
Premanufacture Notification
1-5
August, 1 980
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Pan One
1 Requirements and General 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 Allov 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 Inventory in accordance
with Section 8(b)(1). Thereafter, any person may
manufacture,process, or import the substance without giving EPA
notice. Other manufacturers, processors, importers, or
exporters who manufacture, process, import, or export the same
substance are also subject to any EPA requirements imposed upon
the original notice submitter.*
As premanufacture notification is not a certification process,
lack of any regulatory action by EPA during the notification
period does not prevent EPA from regulating the chemical at a
future date. For certain chemicals, EPA may prefer to initiate
followup actios, rather than regulate the chemical during the
notification period. For example, the manufacture of a toxic
chemica.1 which, the manufacturer states has limited exposure may
not warrant immediate control action. However, 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 of information. This can
be used to track a substance once' it clears Section
5.
• Under Section 5(a)(2), EPA may issue significant new
use rules (SNURs) 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.
* 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.
Enforcement Strategy
Section 5:
Premanufaeture Notification
1-6
August, 1 980
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=3f* One
1 Requirements 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
ei ther:
• Additional data on a substance became available
indicating negative impacts on health or
environment,
• Followup activities indicated serious changes in
exposure, 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., OSHA).
Timetable
An approximate timetable for implementation of Section 5 is
given below. Testing guidelines and significant new use rules
(SWJRs) will be developed during 1980 -81 . 0E will amend the
enforcement strategy as these programs are developed.
Action
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 Some Rules Provisions
Interim Policy - Revised
Final Section 5 Forms and Rules
Section 5 Testing Guidelines
Proposed
General Significant New Use
Rules Proposed
January 10, 1979
May 15, 1979
June 1, 1979
July 1, 1979
(30 days after
Inventory
fcublication)
October 16, 1979
Mid 1980
Late 1980
19 80
19 80
enforcement Strategy
Section 5:
Premanufacture Notification
1-7
August, 7 980
image:
Part One
1 Requirements and General 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 time 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
Ob i ectives
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.
7oluntarv Compliance
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, citizensand workers. The Office of
Enforcement (0E) is currently developing these programs with
the cooperation of Office of Pesticides and Toxic Substances
(OPTS) and Office of Public Awareness (OPA). The programs
should be completed in FY 81.
The voluntary compliance portion of the outreach program will
furnish the information industry members need for understanding
TSCA requirements. This information wilt like-ly include
interpretations and clarifications of specific regulatory
Enforcement Strategy
Section 5;
Pramanufacture Notification
1-8
August. 1 980
image:
"jrr C.-»e
1 Requirements anG Genera' Information
requirements 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 r-emain
within the law.
Tvpe6 of Violations
Noncompliance 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(1)(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 Illegally Produced Substance. If a firm
knew, or had reason to know, that a chemical substance it used
for counnercial 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 Exemption Restrictions. A
firm may seek an exemption from PMN under Section 5(h)(1) in
order to manufacture a new substance for test-marketing
purposes. Under this exemption, the Administrator may impose
restrictions on tie test 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 marketing violations may
constitute a "failure to notify" violation. (See discussion of
that violation category on page 1-10.)
Noncompliance with Research and Development Exemption
Res trictions. 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 time what the term "small
quantities for research and development" means.
Enforcement Strategy
Section 5:
Premanufacture Notification
1-9
August, 1 980
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Pan One
1 Requirements arid General Information
• 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 nondevelopment 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 15(1)(B) which provides that noncompliance with a
Section 5 requirement is unlawful.
Withholding Material Information from or Submission of
Materially Falsa or Misleading Information on a Section 5
Notice or Exemption Request. 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 fail to satisfy the Section 5 requirements,
but their submission is 'prohibited by Section 15(1)(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 commercializes 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 Section 720.12 of the
proposed rules constitutes a "failure to notify" violation.
This action is prohibited both by Section 15(1)(B) of TSCA
which makes it unlawful to fail, or refuse to comply with any
requirement prescribed, by Section 5, and by Section 15(3)(B)
which makes it unlawful to fail or refuse to submit notices aa
required by TSCA. The major variations of this violation
involve unidentified substances, substances identified by
lawful conduct, and substances identified by an associated
violation.
Enforcement Strategy
Section 5:
Premanufacture Notification
1-10
August, 1 980
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=arT One
1 Requirements and Gansral Information
• 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 avoided the
Section 5 requirements by legitimately placing their
substance on the Inventory, 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 o£ 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 purpos-e constitutes h failure to notify
violation because the firm is essentially
producing the substance without notice, or
applicable exemptions.
rnmm»Teial Production of a Research and
Development 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 development exemption, but it is also
a failure to notify violation.
Enforcement Strategy
Section 5:
Premanufacture Notification
1-11
August, 1 930
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Part One
1 Requirements and General 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 aad 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 will always prosecute the test
marketing violation, it will only prosecute the
failure to notify violation when the permitted
production and distribution is exceeded by 100
percent or more.
Bases for Targeting Inspections
In order to obtain the most efficient use of Agency resources,
OE 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 will 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
exportation.
Section 5(a) 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.
Shipping Records. These records will be the basis of targeting
inspections for improper commercial 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'en be inspected.
Exemption Requests and Approvals. 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 may 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 might be
commercializing the substance in violation of Section 5.
Enforcement Strategy
Section 5:
Promanufacture Notification
1-12
August, 7 980
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Pan One
1 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 example, 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 ia 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 I. The violation
detection program is tailored to meet the n£eds of the Section
5 enforcement program taking into account the number of
potential violators, the difficulty of discovering a
violation, and the availa-ble compliance monitoring resources.
Plant Inspections. The principal detection method will 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 comaercia.1 use violation.) Inspectors will need to
examine plant records (production, shipping, storage, disposal
Enforcement Strategy
Section 5:
Prsmanufacture Notification
1-13
August, 1 980
image:
ParxQni
1 Requirements and General Information
etc.), and is some cases they may be required co cake samples
or observe plane operation. To perform these inspections
effectively, inspectors will need special category confidential
business information authorization. (See Program
Implementation Materials 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 iu
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 nay be particularly helpfui in follovup
inspections of previous violators.
Inventory Checks. A firm that violates the requirement to
report a substance for the inventory may also violate Section 5
(failure to notify). Consequently, some Section 5 violations
will be detected by EPA inventory inspections.
Remedies -
After a violation has been discovered and any investigations
and inspections have been completed, OE must determine what
types of enforcement action to take. The possibilities include
issuance of a notice of noncompliance, assessment of
administrative civil, penalties, and initiation of civil, or
crimina.1 court actions.
Enforcement Strategy
Section S:
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1-14
August, 1 980
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Pan Ont
1 Require<n«n» and General Information
TABLE 1 — Targeting Bases and. Detection Methods
Violation
Noncompliance with
Sec. 5(e), Sec. 5(f),
and Sec. 5(f)/Sec. 6(a)
Orders, Rules, or
Injunctions
Commercial Use of an
Illegally Produced
Substance
Noncompliance with
Test Marketing Exemp-.
tion Restrictions
Noncompliance with R&D
Exemption Restrictions
Withholding Material
Information or False
or Misleading
Information
Failure to Notify
Basis for Targeting
Inspections
Section 5 Notices,
Orders, Injunctions,
or Rules
Shipping Records of
Other Firms that
Violated Section 5
Exemption Request
and Approvals
Outreach
Section 5 Notices
or Exemption
Requests
Industry Charac-
terization, Outreach,
Notices, Exemption
Requests, Other
Related Violations
Primary
Detection
Methods
Plant
Inspections,
Subpoenas
Plant
Inspections
Plant
Inspections,
Subpoenas
Plant
Inspections
Plant
Inspections
Plant
Inspections,
Subpoenas,
Inventory
Checks
Enforcement Straiegy
Section 5j .
Premanufacture Notification
1-15
Auaust. 1 S30
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Part Two
Operational Considerations
and Priorities
Contents
Priori
Administrative Considerations
Allocation of Responsibilities
Program Integration
Page
2-1
2-2
2-2
2-3
Enforcement Strategy
Section 5:
Premanufacture Notification
August.-1980
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Pan Two
2 Op«rai!onaf Considerations and Priorities
Priorities
Because of the Agency's limited resources,, ic is important that
OE establish violation priorities £or 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) associated- 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 meant only as a guide to
decision making and is sot a rigid OE policy.
Priority Violation
X Noncompliance with Section 5(e) or
Section 5(f) orders, rules, or
injunctions
2 "Failure to notify"
3 Vitholding material information from
or submission of materially false or
sisleading information on a Section
5 notice or exemption request
4 Noncompliance with test marketing
exemption restrictions
5 Noncompliance with R&D exemption
restrictions
Note.: "TJse 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 restriction, 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.
OE recognises that as the Agency gains experience in
administering the Section 5 enforcement program, these
priorities may be modified to reflect that experience. If QE
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 OE will re-order the priorities.
Enforcement Strategy
Section S:
Premanufacture Notification
2-L
August, 1 980
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?an T wo
2 Operational Considerations and Priorities
Administrative Considerations
Allocation of Responsibilities
The primary role of Headquarters in the enforcement of Section
5 will be working with OPTS in reviewing notices, coordinating
the overall enforcement effort, and taking appropriate
regulatory actions. Since Headquarters will be the only place
where all FMN 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 responsibility 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 exemption 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 Agency resources.
The Regions will be responsible for the Section 5(e)/5(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 amount 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 FY 81 will compel Headquarters
Enforcement Strategy
Section S:
Premanufacture Notification
2-2
August, 1930
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®3fJ r<.vO
2 Operational Considerations and Priorities
to either assist the Regions ia case preparation and Litigation
responsibilities or assume them if necessary. Over the first
two years of the program, Headquarters iavolvement'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 rsponsibilities, the involved
Headquarters attorneys will 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, ifpesticide is
involved, the Federal Insecticide, Fungicide and Rodenticide
Act. Ia addition, an inspection for the discharge of chemical
wastes into- the environment may reveal violations of the water,
air q^ -solid wast® pollution control regulations. Thus, it i$
important 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 u* by those EPA staff administering those
programs, this will be particularly so with Section 8(b)
Inventory inspections. A failure to report^ ,&n eligible
substance for the inventory determination strongly suggests
that the manufacturer in question has also committed a failure
to notify violation.
Enforcement Strategy
Section 5:
Premanufacture Notification
2-3
August, 1 980
image:
'table 2
Headquarters and Regional Roles
Violation
Failure to
Not if y
Noncompliance with
orders, rules,
and injunction
of Sec, 5(e),
Sec. 5(f), and
Sec. 5(f)/Sec, 6(a)
Withholding materiul
information from
or tiubuii6 6ion of
false or mis-
leading informa-
tion on Section 5
notice or exemption
request
Commercial use
of an illegally
produced substance
Noncompliance with
test marketing
restrictions
Target ing
Inspections
HQ lead
Regions support
1IQ lead
Regions support
HQ lead
Regions support
HQ lead
Regions support
I1Q lead
Regions support
Conducting
Inspect ions
Evldeuce
Gathering
Regions lead
HQ support
Regions lead
HQ support
Regions lead
)|Q support
Regions lead
1IQ support
Regions lead
HQ support
Regions lead
HQ support
Regions lead
HQ support
Regions lead
IIQ support
Case Preparation
& Litigation
Regions lead
HQ support
Regions lead
HQ support
HQ lead
Regions support
Regions lead*
HQ support
HQ lead
Regions support
Regions lead*
HQ support
Regions lead*
HQ support
Noncompliance with
It & D restrictions
HQ lead
Regions support
Regions lead
IIQ support
Regions lead
HQ support
HQ lead
Regions support
*The shortage of Regionul resources in FY 80 and FY 81 will compel Headquarters to
either assist the Regions in case preparation and litigation responsibi1ities or assume
these responsibi1ities if necessary.
2-4
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Part Three
Program
Implementation Materials
Contents Paze
Section 5 Inspection Procedures 3-]_
Introduction 3-1
Section 5 Violations List 3.3
Violation Specific Inspection Guidance 3-4
Section 5*Neutral Administrative Inspection Schem^ 3-17
Interiar 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 Background of the
Section 5 Penalty P.olicy 3-35
¦ I " J ' —
Enforcement Strategy August. 1980
Section 5:
Premanufactura Notification
image:
?3r, "r.rae
Introduction to Part Three
The program implementation materials are provided in three
separate documents. The first document, Section 5 Inspection
Procedures, provides general and violation specific inspection
guidance. The TSCA Base Manual. Volume 1 should be referred to
for general 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 Supreme Court's decision,in
Marshall v. Barlow's. Inc.. 436 U.S. 307, 98 S. Ct. 1816
(1978). It will guide both Headquarters and the Regions in
selecting firms for inspections and will 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 will offer
guidance to Regional and Headquarters attorneys in assessing
penalties for violations. This document provides matrices for
measuring Che degree of violation and a penalty assessment
example.
Enforcement Strategy
Section 5:
Pramanufacture Notification
August, 1380
image:
?3rt Thre*
3a
Section 5
Inspection Procedures
Introduction
Inspection Objectives
The objectives of Section 5 inspections are to:
• Determine if firms are submitting their new chemical
substances for Section S review;
• Determine if the firms subject to Secti.o.n 5(e) or
Section 5(f) rules, orders, and injunctions are
complying with their terms;
• Determine if 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 Preparation. Depending upon the type
of inspection involved, the inspector will need to
obtain and review certain documents prior to
conducting an inspection.
enforcement Strategy
Section 5:
Premanufactur® Notification
3-1
August, 1 980
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P.ir; Tires
3a Section 5 Inspection Procedures
The inspector should carefully consider what he will
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-inspection preparation.)
Depending upon the type of inspection involved, the
inspector will need to obtain and review certain
documents prior to conducting an inspection.
Verification Inspections. Inspections focused on
verifying statements in Section 5 notices or
exemption requests will require the inspectors to
become familiar with the statements to be
verified and the form which contains them.
Compliance with Restrictions Inspections.
Inspections focused on compliance with Section
5(e), Section 5(f), or exemption restrictions
will require the inspector to become familiar
with these documents. Review 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 ou the
chemical's production.
• Entry. See procedures presented in TSCA Inspection
Manual, Chapter 3, Section 2.
« Pre-Insnection Conference. Before beginning an
inspection, the inspector should discuss the focus of
the inspection during the opening conference with the
firm's management representative. The inspector
should 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
Enforcement Strategy
Section 5:
Pramanufaeturm Notification
3-2
August, 1 980
image:
Pan Tnree
3a Section 5 Inspection Procedures
relevant Co 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 £2ps his information, and again allay any
fears about the release of confidential business
information. (See TSCA Base Manual for detailed
discussion, at pages 3—61 to 3—63.)
Section 5 Violations List
• Noncompliance with Section 5(e) and Sect-ion 5(f)
orders, rules, and injunctions
• Total production baa
• Restricted production distribution, or use
• Commercial use of an illegally produced 3ubatan<««
• Noncompliance with test marketing exemption
restrictions
• Production, distribution or use restriction
• Recordkeeping violation
• Noncompliance with research and development exempt-inn
restrictions
• Overproduction
• Failure to adequately warn employees
» Failure to use substance for research and
development
Enforcement Strategy " A 19a
Section 5: 3-3
Premanufacture Notification
image:
3a Section 5 Inspection Procedures
Withholding material information from or submission
of materially false or misleading information on a
Section 5 notice or exemption request
Failure to notify
• 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 o£ 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 withholding material information from or
submission of materially false or misleading information on
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. By 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.
Pan Three
Violation Specific Inspection Guidance
The following section presents guidance for conducting Section
5 inspections. Although there are only six main violation
categories, there are variations within each category. These
six violation categories and 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
Section 5:
Premanufactur* Notification
3-4
August. 1 980
image:
Pan Three
3a Section 5 Inspection Procedures
Noncompliance 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
injunc tion.
• Total Production Ban. If 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
relevant records and take a sample if possible.
• Restricted Production. Distribution, or Use. In
those cases where a substance's production,
distribution, 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 Administor has imposed effluent or emission
limitations, the inspector will need to take
samples.
* It is still unclear i£ EPA. has the authority to impose
these restrictions on other firms, but the weight of
analysis favors the position stated in the text.
i«Trrs,"aW 3-5
Premanufacture Notification
image:
Pan Three
Commercial
Use
of
3a Section 5 Insoection Procedures
an Illegally Produced Substance
If a firm knows or has reason Co know Chat a substance it uses
for commercial purposes was manufactured, processed, or
distributed in commerce in violation of Section 5 o.r a Section
5 order, rule, or injunction, it has committed an improper
commercial use violation. OE will interpret "use for
commercial purposes" broadly to include any use in
manufacturing, processing, or distribution in commerce. Thus,
anytime an inspector finds a substantive violation of Section
5, he or she should examine that firms shipping records to
determine what firms, if 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 firm selected for inspection,
Headquarters 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 Headquarters 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 such records by EPA Officials
[4-2 Federal Register 64,57 5 (1977)].
For those substances 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
Section S:
Premanufacture Notification
3-6
August, 1 980
image:
33rt 7-tree
3a Section 5 Inspection Procedures
Analysis of Records. If the substance is:
(1) not on the Inventory,
(2) commercially used by the firm inspected,
(3) covered by TSCA (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 Section 3.*
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, 197 9)].
* 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, 197 9 or was manufactured at any
time for a non-TSCA use.
Enforcement Strategy
Section S:
Premanufactura Notification
3-7
August, 1 930
image:
?3rt Three
3a Section 5 Inspection 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 examine 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.
• Knowledge of Violation. Should the inspector find
evidence that an establishment is commercially using
a TSCA substance that is neither contained on the
Section 8(b) Inventory nor a TSCA exempt substance,
he must look for evidence of knowledge. Knowledge
can be presumed in nearly all cases because the
Section 5 and Section 8 statutory and regulatory
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
SPA meetings relevant to the regulation in question.
(Headquarters would be responsible for establishing
these points.) The regional inspector could add
support co the case by:
(1) establishing whether the firm in question
belonged to any trade as'soc iation,
(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
Section 5:
Premanufacture Notification
3-8
August, 1 980
image:
Par, Three
3a Section 5 Inspection Procedures
If evidence of knowledge 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.
Noncompliance with Test Marketing Exemption Restrictions
A firm may test market a new substance without submitting the
substance for Section 5 review under a Section 5(h)(1) 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 Production. Distribution, or Use
The objective of these inspections is to determine
compliance with the restrictions in the test
marketing exemption. The restrictions (if 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 sales 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 notify issue, see the
inspectional procedures for that Violation on page
15.
m Record Keeping 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 if the records kept by the firm
meet those requirements.
_ Enforcement Strategy
"Section 5:
Premanufacture Notification
3-9
August, 1 S80
image:
PanTnres 3a Sections Inspection Procedures
Noncompliance with Research and Development Exemption
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 this 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
exemption request to guide the inspection.)
The 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 "violations 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 how 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 commercially distributing the substance for a
nonreaearch and development use. Overproduction
strongly suggests illegal commercial distribution of
the substance. Any such distribution constitutes a
failure to notify violation.
• inadequate 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
Section 5:
Premanufactura Notification
3-10
August, 1 980
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Part Three
3a Section 5 Inspection Procedures
present his information to OPTS following the
inspection for a hazard determination. If the
substance is hazardous, the inspector should review
what warnings were given to the firm's employees.
(If 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.
• Nonresearch and Development 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
documents 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
development 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 inspectional procedures
below.
Withholding Material Information from or Submission of
Materially Falsa or Misleading Information on a Section 5
Notice or Exemption Request
This violation occurs as a result of the withholding of
material information from or submission of materially false or
misleading information on a Section 3 notice or exemption
request. A statement is material if the Agency would have or
in fact did rely on it in making its decision not to regulate a
new substance or allow an exemption. Headquarters will direct
what parts of the Section 5 notice or exemption request need
Enforcement Strategy
Section 5:
Pramanufacture Notification
3-11
August, 1 980
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?3rr Tnres
3a Section 5 Inspection Procedures
verification. The inspector mast 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 requests.
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
samples^.
Failure to Notify
The inspector will be looking for evidence that a new substance
is being manufactured, processed, imported, or exported "for
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 Sew Substance. The first approach is
used where the iaspector does not suspect any
violation but discovers a new substance being
improperly produced. There are five steps to follow
in this type of inspection.
Printout. For each firm selected for inspection,
Headquarters will provide a printout of all
substances that this firm has reported for the
Inventory, their CAS numbers (tif available), and
their inventory reporting form number (if
available).
Examine Records. The inspector should examine
shipping records (bills of lading, purchase
forms, etc.) storage records, and production
records foe new substances.
Inventory Status. 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.
Enforcement Strategy
Section 5:
Premanufacture Notification
3-12
August. 1 980
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Pa: Tnres
3a Sacfion 5 Inspection Procedures
Substances Not 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; (1) 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 estblishment has committed a "failure
to notify" violation*. [See proposed regulations
for Section 5, Section 720.2, Section 720.13,
Section 720.14, and Section 720.15 at 44 Federal,
Register., 2264-6S (January 10 , 1979).I
* Identified frew 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 ia 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 eases, there'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, 197 9 or was manufactured at any
time for a non—TSCA use.
Entorc&rr.snt Strategy
Section 5:
Premanufacture Notification
3-13
August, i 990
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Pan Tr.res
3a Section 5 Inspection Procedures
Chemical Wanes. To perform this inspection, the
inspector will need to know the trade'name,
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, produccion, or storage records. Should
the inspector find evidence of a violation, he
should photocopy all relevant records and take a
sample if possible.
• Substance Identified bv 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 submission, improper test marketing, and
improper research and development). The initial
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.
Withholding Information from or Submission of
False or Misleading Information. If the 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 a false and
misleading violation, he should examine the
firm's production and shipping records to see if
the substance was commercially distributed.
Noncompliance with Test Marketing Restrictions.
If the exemption holder produces more 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 EPA 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.
cniorcsment Strategy
Section 5:
Premanufacture Notification
3-14
August. 1980
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?3~ "r.ise
2a Section 5 Inspection Procedures
Noncompliance with the Terms of a Research and
Development Exemption. If a firm claims it is
manufacturing and/or distributing a new 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,
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
establish the failure to notify violation.
Enforcement St.'stagy
Section 5:
Premanu'acture Notification
3-15
August, i 23o
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ran Tfvss
3a Section 5 Inspection Procedures
Enforcement Strategy
Section 5:
Premanufacture Notification
August. 1 930
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Pan Three
3b
Section 5
Neutral Administrative
Inspection Scheme
Two neutral administrative inspection schemes for use in
targeting TSCA Section 5 inspections are discussed in the
following section. The Section 5 notice review program is in
its initial stages and many of the program elements will not
become .fully operational until some time in late FY 80. Thus
the Office of Enforcement (0E) 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 submitcing
materially false or misleading information on a
Section 5 notice or exemption request;
4. Using a substance produced in violation of Section 5
for commercial purposes;
5. Noncompliance with the terms of a test marketing
exemption;
6» Noncompliance with the terms of a research, and
development exemption; and
7. Violation of Significant Hew Use Rules (SinjRs) .
Enforcement Strategy
Section 5:
Pr a manufacture Notification
3-17
August, 1 980
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3b Section 5 Neutral Administrative Inspection Schema
During the first several months of operation, OE anticipates
that Che only active violation categories will be:
noncompliance with Section 5(e) and Section 5(f) orders, rules,
or injunctions, "failure to notify", withholding material
information from or submitting materially false or misleading
information on a Section S notice or exemption request, and
commercial use of an improperly produced substance. Thus, OE's
initial efforts will focus oa these four categories. When the
other categories become active sometime in FY 81, OE will shift
to the final 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 Inspection Scheme
• Noncompliance with Section 5(e) or 5(f) Orders.
Rules. or Injunctions
1. Inspect all firms subject to such orders, rules,
or injunctions
V Failure to Notify*
1. All members that are the subject of improper
production tips and/or complaints
2. A.11 firms that applied unsuccessfully for Section
5 exemptions
3 . A.11 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 SIC
code 2869
(b) All firms with primary manufacture in SIC
code 2865
(c) All firms with primary manufacture in SIC
code 2821
* All the firms in Failure to Notify subcategory 4 are the same
as those in Commercial Use Violations subcategory 3.
Consequently, selected firms should be checked for both
violations when they are inspected.
Enforcement Strategy
Section S:
Pramanufacture Notification
3-18
August, 1 980
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?an Three
3b Section 5 Neutral Administrative Inspection Scheme
5. All firms whose Section 5 notice submissions have
been extended
• Withholdine Material Information from or Submission,
of Materially Falsa or Misleading Information on a
Section 5 Notice or Exemption Request
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
« Commgrcial Use 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 chemcials
3. AIL firms with a history of both new chemical
production and of highly toxic substance
production
(a.) All firms with primary manufacture in SIC
code 2369
(b) All firms with primary manufacture in SIC
code 2865
(c) All firms with primary manufacture in SIC
code 2.821
* AIL the firms in Failure to Notify subcategory 4 are the
same as those in Commercial Use Violations subcategory 3.
Consequently, selected firms should be checked for both
violations when they are inspected.
Enforcement Strategy
Section 5:
Premanufacture Notification
3-19
August, 1 980
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Part Three
3b Section S Neutral Administrative Inspection Scheme
Discussion of Interim Scheme
The interim scheme presented above is divided first 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) all 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 violation 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 insufficient
resources to do a complete compliance monitoriog 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 lower 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 post hoc rationalizations.
* OE 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 for the allocation of
all inspectional resources.
Enforcement Strategy
Section 5:
Pramanufacture Notification
3-20
August, 1980
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3b Section 5 Neutral Administrative Inspection Scneme
For Chose 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 subcategory 4(c) (SIC Code
2821) only if all the firms in 4(b) have been
inspected.
• Commercial Use of an Illegally Produced Substan.ce
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 1 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.
Enforcement Strategy
Section 5:
Pramanufacture Notification
3-21
August, 1 980
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Pan Three
3b Section S Neutral Administrative Inspection Scheme
Discussion af Final Scheme
Sometime, in FTC 81, OE will issue Che final neutral
administrative inspection 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 that 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 FY 81. (At some point ia
the future, OE will add violations of significant new use rules
(SNUR) to the targeting scheme. The general SNUR program will
probably not be fully opperational until late FY 81 at the
earliest. Nevertheless, there will probably be SNTJRs 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 facilitate the statistical
evaluation of the targeting scheme's effectiveness. (See
Evaluation of Targeting Scheme, below, for a discussion of this
evaluation.)
Evaluation of Targeting 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.
I
OE can review these criteria by statistically evaluating the
violation rates of each criterion-defined subcategory in
comparison with the random subcategory of the same violation
category. The violation, races of each subcategory will be
statistically compared to the random subcategory, (if a firm
is selected both ia a criterion-defiaed subcategory aad the
random subcategory, the results will be counted in both.) in
this way, OE will determine if there is a significant
difference betweea the rate of violation of a particular
criterion-defined subcategory and. the random selection of the
members ia that entire violation category. If there is no
significant difference, then OE will realize uhat the criterion
in question should be dropped.
Enforcement Strategy
Section 5:
Premanufacture Notification
3-22
August, 1 980
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?an Three
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 found 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.
Summary of the Policy
Determining the Gravity Based Penalty
The gravity based penalty, based on nature, extent, and
circumstances of the violation is determined by the* General
TSCA Penalty Matrix reprinted on page 3-2S (Matrix I). The
case preparation officer will determine the 1) nature, 2) extent,
Enforcement Strategy
Section 5:
Premanufacture Notification
3-23
August, 1 980
image:
-jr. , 3C Section 5 Penalty Policy Guidance
and 3) circumstances 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 GBP 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, contro1-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 n 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)
, t
2) Control-Associated Data-Gathering Violations
• 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)
Enforcement Strategy
Section S:
Pramanufacture Notification
3-24
August. 1 980
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=an Three
Matrix I
General TSCA Penalty Matrix
EXTENT OF POTENTIAL DAMAGE
CIRCUMSTANCES
(PROBABILITY
OF
DAMAGES)
aiGE RANGE
HID RANGE.
LOW RANGE
A
MAJOR
1 .
2.
$25 ,000
20,000
3. 15,000
4. 10,000
5. 5,000
6. 2,000
SIGNIFICANT
$17,000
14,000
10,000
7,000
3 ,000
1 ,500
C
MINOR
$5 ,000
3 ,000,
1 ,500
1 ,000
500
250
Enforcement Strategy
Section 5:
Premanufacturs Notification
3-25
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Pan Thr«#
3c Section S Penalty Policy Guidance
3) Hazard Assessment Violations
• Failure to notify (all violations)
• Withholding material information from or submitting
false or misleading information on a Section 5 notice
or exemption request
« Noncompliance with research and development exemption
restrictions (overproduction)
• Any violation not listed in the above three
categories
Extant 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 determination.
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 1 and 2 (High) - the violation is likely to
cause damage
Levels 3 and 4 (Medium) -
Levels 5 and 6 (Low)
there is a significant chance
that damage,will result from
the violation
there is less likelihood that
damage will result from the
violation than from a level
3 or 4 violation.
Enforcement Strategy
Section 5:
Premanufacture notification
3-26
August, 1 980
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?3fi Three
3c Section 5 Penalty Policy Guidance
MATRIX II
Extent Level
A » c
Ma3or tlill°g
-*tnn ihs co 2200 lbs. 0 to 10Q Lbs.
Chemical >45.45 kg. " 290.9 kg. 0 to 45.45 kg.
Control >90 K5
Control- > 0Q lbs> t0 >1 ,500 lbs. 0 to 500 lbs.
Associated >J'500 lbs. 2? 27 , t0 >631.31 kg. 0 to 22/ .27 kg
Data- >681.31 <g •
Gathering
>1 tOO lbs >500 lbs. to 21,500 lbs.. 0 to 500 lbs.
Sazard >1.500 »». 2? >27 k Co 2631.31 kg. 0 to 227.27 kg
Assessment >081.0* *5 •
Notes in using Matrix II
1) Production records will generally serve as the extent
basis in the following violation categories:
•- Failure to notify (all violations)
• noncompliance with Section 5(e) or 5(f) orders,
rules, or injunctions
» Noncompliance with test marketing exemption
restrictions
• Noncompliance with research and development
exemption restrictions (all variations)
If the underlying violative conduct does aot relate to
production, another more appropriate record, should be
employed to determine extent. If, for example, the
violator disposes of 5 ,000 lbs. of the substance in
violation of the terms of a 5(e) order, then the disposal
record is the basis of the penalty.
2) The basis of extent in a commercial use violation will
be the amount of iLlegally produced substance received
by the violator.
3) If those records specified above are unavailable, the
penalty should be assessed on those records that are
available.
Enforcement Strategy
Section 5:
Premanufactura Notification
3-27
August. 1 980
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MAT it IX III
Hi mimst ances
l.evel 1
l.evel 2
l.evel 3
l.evel 4
l.evel 5
l.evel (>
Chemical
Coin ro t
V joint ions
a) 5(f) sub-
stance included
in a retail pro-
duct and/or dis-
fribi|ted to con-
sumers
b) 5(e), test
marketed or
Illegal commer-
cial use of sub-
slanco distrib-
uted to consumers
a) 5(f) sub-
stance pro-
cessed by an-
other finu
b) 5(e), tes(:
marketed or
illegal coib-
nercial use
of substance
included in
a retail pro-
duct but not
distributed
to consumers
a) 5(f) sub-
stance which
did not leave
violator's
premises
|>) 5(e), test
marketed or
illegal com-
mercial use
of substance
that was pro-
cessed by an-
other firm
> i
») 5(e),test
marketed or
illegal commer-
cial use of a sub-
Stance that did
not leave v iola-
tor's premises
Nature
of
V iola-
t ion
(*Ollt Vol
Assoc i at oil
pulu - (lath-
ering Vio-
|at ions
Serious impair-
ment and the
missing data is
mv avallable
Serious impair-
ment but tlie
data is avail -
ah 1 e
Important im-
pairment and
the data is
unavailable
Important impair-
ment but the data
is available
Less than im-
portant im-
pairment and
the data is
unavailabl e
l.ess than impor-
tant impairment,
hut the data is
available
Hazard
Assessment
V tolat ions
l:ailure to no-
t ify or with-
hold injj/ false
or misleading'
violations where
substance was dis
IrjIjiilet 1 to con-
sumers
l-ailure to no-
tify or wilh-
hol d ing/J'a 1 se
or mi siending
violations where
substance was
not distrUnited
to consumers
Research and
development
overproduc-
t ion where
some or al 1
of the pro-
duction not
accounted for
Research and de-
velopment over-
production where
-all of production
accounted for
3-
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?an Three
3c Section 5 Penalty Policy Guidance
The factors used in considering circumstances vary with the
nature of the violation. These factors are presented below and
summarized in Matrix III on page 3-28. The case preparation
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 iQ
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 noncompliance with 5(f) orders, rules, or
injunctions, the initial circumstances level is 2.
»¦ For the other violations in this category, the
initial circumstances level is 3.
2) Adjustment Factors:
• If the substance never left the violator's 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
distribution but never shipped to' the retail
distributor, the circumstance level increases by one
1 ev e 1.
• rf any of the produce was distributed to consumers or
was released uncontrolled into the environment, the
circumstance level will be increased by two levels.
Control-Associated Pata-Cachering 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
Enforcement Strategy
Section 5:
Premanufacture Notification
3-29
August, 1 980
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Parr Three
3c Section 5 Penalty Policy Guidance
initial circumstance level) and 2) the availability of the
missing information from otirer 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, tha level will be 6.
2) Adjustment Factor
• If the missing information cannot be produced by the
firm within.five working days, the circumstance-
determination will be increased by one level.
Hazard 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 Circumstance Level
• Failure to notify and withholding false or misleading
information violations automatically receive a level
of 2.
• Overproduction of a research and development
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 Co notify, or withholding false or misleading
information violations be distributed to consumers
the circumstance range would be increased to the *
highest level.
Enforcement Strategy
Section 5:
Premanufacture Notification
3-30
August, 1980
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Part Three
3c Section 5 Penalty Policy 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 level 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 Penalty
Follow the adjustment factor application instructions as
presented in the general TSCA penalty policy document, "TSCA
Civil Penalty System" of March 10 , 1980 at pages 9-16. The
only addition, to these instructions will be in adjustment
factor 4, economic gains from noncompliance. Here the penalty
should equal the gross sales of the illegally produced product.
The penalty should, in any case, not exceed the $25,000 per day
statutory limit following the application of adjustment factor
4.
Imposing Penalties on a Per Day 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 violations; 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, tjip penalty will be
assessed on the basis of the amount of substance involved in
that 24 hour period.
Continuing 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).
Enforcement Strategy
Section 5:
Premanufacrure Notification
3-31
August, 1 980
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3c Section S Penalty Policy Guidance
• Commercial. use of an illegally produced substance.
• Noncompliance with cesc marketing exemption
restriction (those aspects dealing with controlling
the substance).
• Failure to notify.
Noncontinuing Violations
• Noncompliance with test marketing exemption
restriction (record keeping aspects).
• Noncompliance with Section 5(e) or 5(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 submission
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 adjustment
factors for "government 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 toeach day's penalty
(although each day would still be limited to a maximum
$25,000) .
Example
A hypothetical firm was found to be producing a new TSCA
substance that had never been submitted to EPA for PMN review.
The violator voluntarily 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 product:, 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 Strategy
Section S:
Premanufacture Notification
3-32
August. 1 980
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Part 7,-iree
3c Section 5 Penalty Policy Guidance
substance that was already on the inventory. The gross annual
sales of the firm is $3,500,000 . (The penalty is worked out on
the worksheet at page 3-34.)
¦jhis 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 upward
because none of the new product reached consumers. This
results in a gravity based penalty (GBP) of $20,000 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 GBP. But the recall of the product by
manufacturer is evidence of a good attitude and the penalty is
adjusted down by 152 »
The firm has one prior violatio4n. 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 352 (502 — 152 ¦ 352)• 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 y^eld $1,500,000.
There were no government clean up costs from the violation as
all 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 ,500,000 anualiy. The 4 percent
gross sales yields a figure of $140,000. Thus, the penalty
would be $140,000.
Enforcement Strategy
Section 5:
Premanufacture Notification
3-33
August, 1 980
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CIVIL PENALTY ASSESSMENT WORKSHEET
Name of Respondent:
Address of Respondent:
(1) Complaint I.D. Number: ___________________
(2) Date Complaint Issued: ____________________
(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 increase or decrease for
culpability -15 Z
3. Percent increase for violation history . 50 Z
4. Add lines 2 and 3 35 Z
5. Multiply GBP 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
3. 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
I
11. Add lines 8 through 10 $ 1,500 .000
12. Total of other adjustments as justice
may require ....... . 0 ,
13.. Add. (or aubstract) line 13 to
(from) Line 12* 1 .500 .000
14. Maximum penalty for. small firm, (42 of
gross receipts) if applicable and the
information is available $ 140.000
*Line 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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Par; Tr.rae
3c Section 5 Penalty Policy Guidance
Detailed Background o£ the Section 5 Penalty Policy
This section states the rationale behind the policy summarized
in the first portion of this document.
Mature 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 bans.
Subsection 5(h)(1) 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 fail 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. Suck a violation is more a worker
protection law than a toxic substance control law
and may ultimately be enforced by the Occupational
Safety and Health Administration. However, for
penalty policy purposes, OE will consider it a
chemical control question.
2. Control-associated data-gathering requirements are
recordkeeping and/or reporting requirements
associated with a chemical conrrbl 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
restrictions would also fall into this category as
Section 5(h)(1)(B) authorizes the Administrator to
impose, among other things, recordkeeping and/or
reporting requirements.
Enforcement Strategy 3-3 5 August, 1 980
Section S:
Premanufacture Notification
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Part 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 otis leading informs tion, 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 premanufacture review, the penalty will be assessed on
the basis of the production records which indicate 30,000 lbs.
illegal production. Production records will generally serve as
the penalty basis in the following violation categories:
• Failure to notify Call variations)
• Noncompliance with Section 5(e) or 5(f) orders,
rules, or injunctions
• Noncompliance with test marketing exemption
restrictions
• Noncompliance 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.
Enforcement Strategy
Section S:
Premanufacture Notification
3-36
August, 1 980
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3c Section S Penalty Policy Guidance
It 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 sise increases rapidly for each bag. The
violations in the other two categories are generally less
serious and the penalty assessment increases mora 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 of 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
Application of the Extent 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 minpr 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-gathering. 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. (6 81.81
kg.) .
Enforcement Strategy
Section 5:
Premanufacture Notification
3-3 7
August, 1 980
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=3r: Three
3c Section 5 Penalty Policy Guidance
3) Hazard 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-assoc 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. (6 81.31 kg.).
as the Violation
Circumstances are used in 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 category on Haxtrix III (See page 3-28).
Then the officer would select the appropriate circumstances in
that category. Those circumstances involve a two step process.
The initial level is set by the overriding circumstance and
adjusted upward or downward depending on other less crucial
factors. The matrix provides the following levels for
measuring circumstances (probability):
Level 1 and 2. (High) - 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 /Aan from Level 3
or Level 4 violation.
Application of the Circumstances Factor to Section 5
I) Chemical control. For these violations, the initial
circumstance 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
Section 5:
Premanufacture Notification
3-38
August, 1 980
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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 substance's
toxicity is unreasonable, as in all 5(f) actions,
the toxicity level will 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 product was distributed to
consumers or was released uncontrolled into the
environment, the level will be increased by two.
2) Control-associated data-gathering. 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 monitoT 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 bjr,the firm within 5
working days of the inspection, the 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
mis-leading violations present such a serious
likelihood, of damage 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 much less serious
Enforcement Strategy
Section 5:
Premanufacture Notification
3-39
August, 1 980
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Par. Three
3c Section 5 Penalty Policy Guidance
violation and is assigned an initial circumstance
level of 6. If 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 §25,000 but that each day a violation continues is a
separate violation for which penalties maybe assessed. Thus
TSCA could allow for very large penalties. Tor some
violations, these large penalties will be appropriate. For
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 penalise Section
5 violations falling into the contro1—associated data—gathering
category, research and development exemption restriction
violations (overproduction) and. withhoIding/false or misleading
violations. The other violations are inherently more serious
threats to public health or the environmentjand will be subject
to the larger penalty that a per day analysis would provide.
Continuing violations are as follows:
• Noncompliance with Section 5(e) and. Section 5(f)
orders, ruLes, and injunctions (chemical control
aspects)
» Noncompliance,with research and development exemption
restrictions (violation of adequate warning
requirement)
• Commercial use of an illegally produced substance
_ Enforcement Strategy
Section 5:
Premanufacture Notification
3-40
August, 1 980
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3c Section 5 Penalty Policy Guidance
• Noncompliance with Case 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 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 adjustment
factors for "government 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 cost3,
$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).
enforcement Strategy
Section S:
Premanufacture Notification
3-41
August, 1 980
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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
image:
COMPLIANCE STRATEGY FOR THE TSCA 55(h)(4) PREMANUFACTURE
NOTICE EXEMPTION FOR CHEMICALS USED IN OR FOR INSTANT
PHOTOGRAPHIC OR PEEL-APART FILM ARTICLES
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 ^2_r ^4308 (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
not be distributed in commerce or used until a premanufacturi
jiotice under section 5(a)(1)(A) 1s 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.
ffEQUlft£MEHTS OF Ttifc. kKLT
Appli cabil1ty
This rule establishes the conditions for an exemption from
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
®*®^ption or submitting a premanufacture notice for the specific
M^'cal to EPA 90 days prior to manufacturing or processing the
^^fchemical 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.
Notice 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.
Requirements to Limit Exposure
All manufacturing, processing, and use operations involving
the new chemical substance must be performed in a demarcated,
special production area under the conditions found in Table II
Jntil the substance has been incorporated into a wet mixture,
Photographic article, or instant photographic or peel-apart film
arti-cl e.
The following activities are. allowed outside the special pro-
duction area provided the conditions given in Table II for these
ictivities 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.
5723.175(e)(8)
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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 in tent 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.
"-^ME MOMENT AMD REPEAL
The regulation provides for amending or repealing any term of
the exemption by formal rulemaking if 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)
REGULAR!) IMbUMkY
The regulated industry consists of those companies wh0<1) manu-
fart,. D ocess a new chemical substance used in or for instant
Srpeel-apart film articles and 2) manufacture the
artfcle and 3) sSbmit an exemption notice. EPA 1s aware of only
?wo companies which meet the first two requirements - Polaroid and
Kodak Therefore, they are the only two companies expected
W , ; for ", exemption. Each of these firms has several
¦>?tes where chemicals may be manufactured under the exemption.
designation of the location of manufacturing sites is required
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in the exemption notice.
rW-MCEMENT
^FORCEMENT 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.
(~Failure to file a notice when other exemption conditions are
not met is a PMN 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.
0 MONITORING
Failure to monitor.
Failure to monitor properly, e.g., unsuitable sample methods,
incorrect intervals, improper location.
8 ENGINEERING CONTROLS & EXPOSURE SAFEGUARDS
No engineering controls and exposure safeguards used where
requi red.
Inadequate engineering controls and exposure safeguards used
where required.
No labeling where required.
Improper or incomplete labeling where required.
° RESPIRATORY PROTECTION
Proper respirators not provided for individuals in Special
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Production Area (SPA).
Respirators not worn by individuals in SPA.
'Quantitative fit test not performed.
TRAINING
No training program.
Not all required individuals attend.
Inadequate/incomplete training program.
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 spi11/release control.
.Written procedures for responding to emergency situations not
^immediately accessible to employees in SPA.
Materials 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
equi pment.
PERSONAL PROTECTION DEVICES
Improper clothing or equipment.
CAUTION SIGNS
No signs.
Improper signs.
ENVIRONMENTAL RELEASE AND WASTE TREATMENT
waste not handled as hazardous waste.
Wastewater or discharge not pretreated.
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-6-
Wastewater or discharge not properly pretreated.
Process emissions not vented through appropriate control
devi ces.
0 RECORDKEEPING
Records not kept.
Records incomplete.
° RECORDS SUBMISSION
Records not submitted.
Records not submitted on time.
0 PROHIBITION
Prohibition violated.
0 AMENDMENTS
Violation of an amendment.
There have been no amendments at this time.
inspections
Neutral Administrative Inspection Scheme
Mi cites where chemicals are being manufactured/processed
^Iru are kept under this exemption will be inspected on a
or Records are kep should inspect each site after an
periodic b^ls. 1 ic| is submitted for that site, preferably
'IImS 120 "Sys after the notice Is. submitted. If no violations
within • should inspect again approximately one year
are found, the Region jnou Jt.on_ [f „„ violations are
fr0l during the second inspection, then the Region should re-
inspect each site approximately every two years.
Tf uinlat1ons are found, the Region should reinspect the site
riSvs This should continue until two consecutive mspec
within 120r^*'ted and no violations are found. After that, the
Reglon^hould lnspect the site approximately every two years.
Inspections may also be conducted at other companies/s1tes
based on tips or referrals.
Scheduling Inspections
Prior to scheduling inspections, the Region should contact
the company to discuss when the exempt chemicals will
image:
-7-
factured, where the records are kept» oil^dat^nee^no?
when EPA could Inspect. A specific Jnlowtlons ar!
be arranged with the company. Unannounce . .P . . exemntion
considered desirable to assure compliance with this exemption.
ADMINISTRATIVE CONSIDERATION?
Allocation of Responslbl1ities
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 PTSED.
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 (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 OTS concerns. maiviauai
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 regardino
compliance with the exemption regulation.
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-8-
4- Revld 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.
Arraror expert witnesses.
7. Make mmendatlons to OTS regarding amendments, repeal,
or prition of use of the exemption.
Reqi ons
The Regioril1:
1. Contaae company after receiving a copy of the exemp-
tion n:e from PTSED to determine when the exempt
chemic'n'll be manufactured, where the records are
kept, a time frame for inspection.
2. Schedulnspections based on the neutral administrative
inspect scheme in this strategy.
3. Perfonme 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.)
Program Integratii
During an insection to determine compliance with the exemption,
the inspector shoud also inspect for compliance with other TSCA §5
requirements. Prir to conducting an inspection to verify compliance
with the exemption the Region should contact PTSED regarding other
TSCA §5 submi ssioni'ac ti v i ti es of the company.
Through fhe ccnpliance monitoring activities related to the
enforcement of TSCA§5, the inspector may obtain compliance monitor-
ing information invjiving other EPA enforcement programs. For
example, an inspector may turn up violations relating to other
parts of TSCA or of the water, air, or solid waste pollution control
regulations. Thus, it is important for all those involved in
Section 5 enforcement to communicate non-Section 5 compliance
monitoring information to the appropriate office in EPA.
image:
TABLE I
INFORMATION REQUIRED IN THE EXEMPTION NOTICE
1. NAME OF MANUFACTURER - §723. 175( 1 ) {1) (i)
2. SITES AND LOCATIONS WHERE THE SUBSTANCE WILL BE MANUFACTURED
AND PROCESSED - §723.175( 1 )(1 ) ( 1 )
3. CHEMICAL IDENTITY - §723.175(i)(1) (ii)
4. IDENTITY OF IMPURITIES REASONABLY ANTICIPATED
§ 7 2 3 . 17 5 (i) (1) (i i i)
5. DESCRIPTION OF PHYSICAL AND CHEMICAL PROPERTIES
§723.175(i)(l)(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(i)(l)(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( 1 ) (1 ) (vi11 )
10. DESCRIPTION OF METHODS USED TO CONTROL AND TREAT WASTEWATER
OR DISCHARGE RELEASED TO A POTW OR OTHER RECEIVING BODY OF
WATER. IDENTITY OF POTW OR OTHER RECEIVING BODY OF WATER.
§723.175(1)(l)(ix)
11. CERTIFICATION THAT THE MANUFACTURER IS FAMILIAR WITH AND
WILL COMPLY WITH THE TERMS OF THE EXEMPTION - §723 .175( 1 )( 1 )(x }
ACRONYMS USED IN TABLES
POTW - Publicly Owned Treatment Works
TWA - Time Weighted Average
SPA - Special Production Area
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REQUIREMENTS^) limit exposure
SPECIAL PRODUCTION AREA
(SPA)
AREA ADJACENT
TO SPA
REMOVAL FOR
STORAGE OR
PROCESSING WET MIXTURES
OUTSIDE SPA
INCORPORATION
INTO ARTICLES
POSURE
MITS
Air Concentration - TWA
10 ppra for gases and vapors
50 ug/ro for particulates
Allowable TWA excursion of 50%
above for 30 minutes or less.
§723.175(e)(1)
Must not ex-
ceed limit for
waiver of res-
pirator protec
tlon in SPA.
§723.175(e)(10)
Must limit
exposure.
§723.175(e)(8)
Must take mea-
sures to limit
exposure dur-
ing operation
using engi-
neering con-
trols, train-
ing, hygiene,
work practice
and personal
protective
devices.
§723.175(g)
NITORING*
When suit-
able samp-
ling and
analytlca
methods
exist.
Must 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.
§723.175(e)(3)(A)
(See this section for details
of monitoring.)
Periodic
monitoring same
as for SPA In
areas where it
Is reasonable
to expect a
risk of inhala-
tion exposure.
§723.175(e)(10)
?crnonc ornurprn rn nr matmtaturn
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TAB^fl
REQUIREMENTS TO LIMIT EXPOSURE
SPECIAL PRODUCTION AREA
(SPA)
AREA ADJACENT
TO SPA
REMOVAL FOR
STORAGE OR
TRANSPORTATION
PROCESSING WET MIXTURES
OUTSIDE SPA
INCORPORATION
INTO ARTICLES
ITORING*
hen suit-
ble samp-
1ng and
nalytical
iethods
;o not
•xist.
A surrogate chemical substance
possessing comparable physical
chemical properties under
similar manufacturing and pro-
cessing must be used to assure
compliance with exposure
1Imlts.
§723.175(e)(3)(B)
Same as for
<%PA
5723.175(e)
(3)(B)
INEERING
TROLS 4
OSURE
EGUARDS
Controls and safeguards must
be used to ensure compliance
with exxposure limits.
§723.175(e)(4)
LabelIng
required. Must
include Identi-
ty or code,
statement of
any known haz-
ards, handling
instructions,
first aid
information,
spill control
directions, and
DOT notations.
§723.175(e)(9)
Must limit exposure, to
the new chemical sub-
stance.
§723.175(f)(1)
Controls and
safeguards
must be used
to limit
exposure to
the new chem-
ical substance.
§723.175(g)
PIRATORY
TECTION*
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
I ug/m for particulates with
I allowable TWA excursion above
for 30 minutes or less.
I
I $7?1.17Z(p)(?)
I
image:
TABLE II
REQUIREMENTS TO LIMIT EXPOSURE
SPECIAL PRODUCTION AREA
(SPA)
AREA ADJACENT
TO SPA
REMOVAL FOR
STORAGE OR
TRANSPORTATION
PROCESSING WET MIXTURES
OUTSIDE SPA
INCORPORATION
INTO ARTICLES
Required before employee can
enter. Must cover known phy-
sical-chemical and toxlcolo-
glcal properties of chemicals
handled in the SPA, procedures
for using personal safegaurds,
hygiene, handling procedures,
emergencies, and spills.
§723.175(e)(5)(1)
Required for employees
handling wet mixtures.
Must cover procedures for
using personal exposure
safeguards, hygiene,
handling procedures,
emergencies and spills.
§723.175(f)(2)(i)
Facilities for changing and
washup must be provided. No
food, beverages, tobacco pro-
ducts, or cosmetics allowed
In the Special Production
§723*.l75(e)(5)(11)
Appropriate standards that
limit exposure must be
used by employees handling
the wet mixtures.
§723.175(f)(2)(H)
Hygiene must
1imit expo-
sure.
§723.175(g)
Must be designed to ensure
compliance with exposure lim-
its. Spills or unanticipated
emissions must be controlled
by trained personnel wearing
suitable protective clothing
or equipment, such as chemi-
cal-resistant coveralls, pro-
tective eyewear,and gloves.
Written procudures and all
materials necessary for emer-
gency situations must be Imme-
diately accessible.
§723.175(e)(5)(111)
Must be designed to limit
exposure to the new cheml-
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.
§723.l75(f)(2)(111)
Work practices
must limit
exposure.
§723.175(g)
RECORDS REQUIRED TO BE MAINTAINED
image:
TABLE II
REQUIREMENTS TO LIMIT EXPOSURE
SPECIAL PRODUCTION AREA
(SPA)
AREA ADJACENT
TO SPA
REMOVAL FOR
STORAGE OR
TRANSPORTATION
PROCESSING WET MIXTURES
OUTSIDE SPA
INCORPORATION
INTO ARTICLES
Workers 1n 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.
§723.175(f)(3)
Personal pro-
tective de-
vices must be
used to limit
exposure.
§723.175(g)
Area must be clearly posted.
Sign must restrict entry to
trained personnel equlped 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
0 RELEASE TO LAND - §723. 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 - 5723.175(h)(2)
Wastewater or discharge must be pretreated before release to
a POTW or other receiving body of water. To release to a POTW,
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-
perties .
0 RELEASE TO AIR - §723. 175(h)(3 )
All process emissions must be vented through appropriate control
devices.
image:
TABLE IV
RECORDKEEPING*
0 PRODUCTION RECORDS - §723 . 175(j ) (1) (i)
Annual Production Volume**
Date manufacture began
° EXPOSURE MONITORING - §723 .175(j ) (1) (11)
Record of all monitoring including:
Chemical 1 d e n t i ty
Date of moni tori ng
Actual monitoring data for each monitoring location and
sampl1ng
Reference to or description of collection and analytic
techniques
If manufacturer does not monitor, records of reasons for not
monitoring and the methods used to determine compliance with
exposure limits must be kept.
H 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 information related to worker's exposure.
0 TREATMENT RECORDS - §723.175{j)(1)(iv)
Method of treatment if manufacturer releases treated wastewater
or discharge containing a new cTiemical substance to POTW or
receiving body of water.
~Records must be kept for 30 years following the final date of
manu faacture.
*A1though not required to be kept by the regulation,informa-
tion as to the estimated annual sales volume should also be
requested by the inspector.
image:
^0ST4%
W
"ȣ BRQtfc0
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
- ?5
' "* W -w '-J 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
comments received earlier from Headquarters and Regional
personnel. Major changes from the initial draft include a
more specific delineation of compliance monitoring prioriti
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.
"V
xes
v/-
A. E. Conroy Director
Pesticides and Toicic Substances
Enforcement: Division
image:
INVENTORY REPOKTIN3 REGULATIONS
FINAL ENFORCEMENT STRATEGY
TABLE OF CONTENTS
I. Summary ^
II. Strategy Development 2
A. Regulation 2
1. Objectives 2
2. Requirements 2
3. Regulated Industry 5
4. Timetable 6
B. Strategy Development §
1. Objectives 6
2. Priority Violations 7
3. Compliance 9
a. Voluntary Compliance 9
b. Compliance Monitoring 9
1) Tools 9
2) Application of Tools to Violations iq
3) Priority Activities X4
III. Strategy Implementation ]_g*
A. Program Management 15
1. Allocation of Responsibility 15
2. Delegation of Authority - Confidentiality Clearance 20
B. Outreach 20
C. Compliance Monitoring Program 20
1. Confidentiality 20
2. Training 21
3. Inspection Sites 21
4. Inspection for R&D Substances 21
5. Post Inspection Procedures 22
D. Enforcement Proceedings 22
1. Determination that a Violation Exists 22
2. Selection of Proper Enforcement Action 23
3. Liability 24
4. Civil Penalty Assessment Procedure 25
E. Program Integration 29
1. TSCA Programs 29
2. Other EPA Programs 30
image:
TABLE OF CONTENTS
Data Sources
Inspection Procedures
Violation Worksheet
Violation Citation Charges/Action Levels
Evidence in Support of Charges
Gravity Base Penalty Matrix
Guidance for Use of TSCA
Civil Penalty Assessment Worksheet
TSCA Civil Penalty Assessment Worksheet
Federal Register Publicatons
Statutory Authority
Appendix A
Appendix B
Appendix. C
Appendix D
Appendix E
Appendix F
Appendix G
Appendix H
Appendix I
Appendix J
image:
inventory reporting regulations
FINAL ENFORCEMENT STRATEGY
I. Summary
Inventory reporting regulations were promulgated under §8 (a) of
the Toxic Substances Control Act (TSCA) on December 23, 1977. The
major objective of the regulations is to allow EPA to acquire information
necessary for the compilation of an inventory of chemical substances
currently manufactured, imported, or processed for a commercial purpose
in the U.S., as required by TSCA §8(b). An initial inventory based on
reports frcm manufacturers 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 opportunity 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 manu-
facture a chemical substance or import in bulk any substance not on the
inventory must notify EPA at least 90 days in advance. Substances which
complete this premanufacture notification process and are manufactured
for a non-exempt *ccmmercial purpose will be added to the inventory.
This document contains the strategy of the Office of Enforcement
(OE) for enforcing the inventory reporting regulations. It discusses
the regulation requirements, violations, priority compliance monitoring
activities for FY79 and 80, case preparation and penalty assessment proce-
dures as well as the allocation of responsibilities between Headquarters
and the Regions.
Headquarters will have the major responsibility for selecting subjects
for compliance monitoring while the Regions will be responsible for
conducting inspections and case preparation.
In FY79 OE will concentrate its major efforts on detecting reporting
of substances excluded frcm the inventory 1) because manufactured or
imported solely for research and development or 2) becaase not mamfactured
or imported after January 1, 1975. OE will also attempt to identify persons
who failed to report for the initial inventory as required and whose
substances are beirg reported by processors during the revised inventory
reporting period. In FYSO, after publication of the revised inventory,
OE will use its resources primarily to respond to reports of inventory
reporting violations.
* See definition xn prcoosed premanufacture notification requirements
(44 FR 2242).
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- 2 -
II. Strategy Development
A. Regulation
1. Objectives
The inventory reporting regulations promulgated under §8(a)
of TSCA have two primary objectives.
First the regulations require information necessary for com-
pilation of the inventory of chemical substances required by
TSCA §8(b). TSCA §8(b) requires that the Administrator compile,
keep current and publish a list of chemical substances currently
manufactured or processed for a commercial purpose in the U.S.
Since the term "manufacture" includes "to import into the customs
territory of the U.S.," the inventory will also include chemical
substances imported for a commercial purpose. Any substance not
on the inventory is a "new" chemical substance. Under the §5
premarufacture notification requirement, a marufacturer of any
new chemical nust notify EPA before he can manufacture it for a
non-exempt canmercial purpose.
The inventory will be a continually expanding list. The
initial inventory is expected 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 bulk. Sub-
stances which complete the prema ru fa cture notification process
and are to be manufactured for a non-exempt canmercial purpose
will be added to the inventory. For a 210 day period after
publication of the initial inventory, additional chemicals may
also be added to the list by processors, users and certain importers.
Secondly, under authority of TSCA §8(a)(l)(A), these regulations
require reporting of production and site information which is
reasonably necessary for establishing a profile of the chemical
industry, monitoring chemical substances in the environment, and
setting Agency priorities for implementing other provisions of
TSCA.
2. Requirements
a. The initial inventory
Marufacturers and importers had to report for the initial
inventory concerning all chemicals they manufactured or
imported for a canmercial purpose in 1977 if (1) thirty per-
cent or irore, by weight, of the products manufactured or
imported consisted of the types described under Standard
Industrial Classification (SIC) Grcup 28 or 2911, or 2) the
total pounds of reportable substances equaled one million
pounds or more. In addition, marufacturers and importers
had to report concerning any chemical that was manufactured
image:
- 3 -
at a sinqle site or imported during 1977 in quantities greater
than 100,000 pounds. Companies which fell within the criteria
had to report:
1) the identity of each chemical substance,
2) for any polymer, the identity of at least those moncners
used at greater than two percent (by weight) in the maru—
facture of that polymer,
3) whether each substance reported was manufactured or
imported,
4) the site(s) where the substance was marufactured or
imported, whether the maru facture was site limited, and
5) the anount (in broad ranges) manufactured at each site
or imported during 1977.
Small manufacturers and importers did not have to report
production volune or the site(s) where a substance was manu-
factures or imported. A manufacturer or importer qualified
for this exception 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 not required to report for the inventory could,
nonetheless, report any substance they had manufactured or
imported for a canmercial purpose since January 1, 1975.
To avoid potential premaru facture notification, such persons
were responsible for ensuring that eligible chemicals they
manufactured or imported were reported by someone.
All information for the initial inventory had to be reported
by May 1, 1978. On April 17, 1978, the Agency announced that
a manufacturer or importer unable to meet this deadline because
of extenuating circumstances might be granted an extension
not to exceed June 1, 1978.
Persons beginning mamfacture or importation of a chemical
substance during the period between May 1, 1978 and the effective
date of the premanufacture notification requirements are required
to submit an inventory report when manufacture or importation
begins.
image:
- 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. During the 210 day reporting
period, however, any eligible chemical substance not on the
initial inventory may be reported by those who (1) have pro-
cessed or used the chemical for a commercial purpose since
January 1, 1975 or (2) have imported the chemical as part of
a mixture or article since January 1, 1975. (The latter persons
were also able to report for the initial inventory). Such
persons need only report chemical 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 from prosecution under TSCA
§15(2) for using a substance in violation of the premanufacture
notification requirements of §5. Importers of chemical
substances as part of mixtures avoid going through premanu-
facture notification by reporting during this period.
c. Reporting by trade associations or other agents
A trade association or other agent could not report for anyone
required to report for the initial inventory.
A trade association could report for any of the following
persons:
1) anyone who has manufactured or imported a chemical substance
for a canmercial purpose since January 1, 1975 and who was
not required to report for the initial inventory.
2) any processor or user of a chemical substance who chooses
to report for the revised inventory.
3) anyone who imports a chemical substance as part of a
mixture or article and chooses to report for the revised
inventory.
d. Prohibited 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 research 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 manufactured, imported, or processed for
a canmercial purpose since January 1, 1975.
image:
- 5 -
These substances include pesticides, tobacco products,
nuclear materials, firearms, and foods, drugs, cosmetics,
or medical devices.
4) mixtures.
In addition chemicals which are not considered to have been
manufactured, imported, or processed for a commercial purpose
per se are excluded from the inventory. Examples of such
chemicals are impurities, by-products which have no commercial
purpose themselves, chemicals which are not intentionally removed
from the equipment in which they were manufactured, and certain
other incidental chemicals (see 710.4(d)(3)—(8)).
e. Recordkeeping requirements
All 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, must keep records
indicating which manufacturer, importer, or processor will
be able to document to EPA. that reported chemicals were manu-
factured, imported, or processed since January 1, 1975.
f. Confidentiality
Manufacturers, importers, and processors may claim any
item of reported information to be confidential, including
the specific chemical identity. Confidentiality claims
must acccmpany the reported information and must be sub-
stantiated by a signed certification statement. EPA will
not disclose a confidential chemical identity to inquiring
dianical manufacturers unless they can show a bona fide
intent to manufacture the particular chemical (section 710.7(g)).
3. Regulated Industry
A characterization of the chemical industry performed for EPA
indiates that 10,000 manufacturers comprise the industry. 150
of these firms with sales of $100 million account for 80% of
industry sales.
There are no accurate figures available regarding the number
of importers subject to the inventory reporting requirements.
According to the American Importers Association, there are at
least 1200 brokers and up to 35,000 importers who might be
affected.
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4. Inventory Development Timetable
The following is a timetable of major dates in implementation
of the inventory. Related Federal Register publications are listed
in Appendix J.
Dec. 23, 1977 Promulgation of final inventory reporting
requirements
May 1, 1978 Deadline for submission of forms for initial
inventory
June 1, 1978 Extended deadline for submission of reporting forms
May 1979 Publication of initial inventory
June 1979 Premarufacture notification for manufacturers
and importers of chemical substances in bulk
May 1979 Complete computer system (Informatics) operational
February 1980 Publication of revised inventory
March 1980 Premarufacture notification for importers
of chemical substances as part of a mixture
B. Strategy Development
1. Objectives
The major objectives of a program for enforcement of the inventory
reporting requirements are:
a. to help ensure the integrity of the inventory so that it will
act as an effective guide for premarufacture notification
under TSCA §5.
b. to ensure the accuracy of production and site information
which will be used by EPA to set priorities for implementing
other sections of TSCA.
The inventory will be the sole basis for triggering the
premarufacture notification requirement under TSCA §5. The site
and production information reported, however, will probably
not be the only elements used in the determination of priorities
for implementing other TSCA sections. Therefore, the Office of
Enforcement will use its limited resources primarily to reach
the first objective.
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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 time
g. clerical errors
This strategy ranks each potential violation on the basis of the
economic incentive for its commission, 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 from the inventory
Thirty days after publication of the initial inventory,
any person who wishes to manufacture or import in bulk a
chemical substance not on the inventory must comply with
the premarufacture notification requirements of TSCA §5.
If a §4 testing rule is applicable to a new chemical substance,
a person must have the required test data before he can submit
a premarufacture notice. In addition submission of prenanu-
facture notification may delay, limit, or prohibit production
of a substance under §5(e) or §5(f). A person wculd have a
major economic incentive to report for the inventory any
chemical substance he intends to manufacture or import in the
future to avoid §5 requirements.
r&D substances and substances not manufactured, imported
or processed since January 1, 1975 are excluded frcm the
inventory by statute. Congress intended these substances to go
through the premanufacture notification process before being
manufactured or imported for a earnercia 1 purpose. Substances
not currently under the jurisdication of TSCA are also excluded.
(See II A.2.d.3) If these categories of substances (particularly
the former two) are included in the inventory, the success of
the premanufacture notification process will be jeopardized.
Because of the great economic incentive for committing this
violation and the great impact of the violation on §5
implementation, OE considers reporting excluded substances
the most important inventory violation.
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b. Reporting False Information
Same persons may submit false data with respect to production
volume and whether the substance is distributed for commercial
purposes outside the production site. The inventory reporting
regulations required reporting of production volume only in
broad ranges. However, a company might report a much lower
production volume 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 chemicals or substances not manufactured since
January 1, 1975 to avoid premarufacture notification requirements.
A company miqht report that a substance is not site limited
to avoid premarufacture notification which might be required if
later distribution outside the production site is covered by a
significant new use rule. There is no major economic incentive
for reporting false data aside from that associated with
avoidance of premanufacture notification. To the extent that
submission 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 impact
implementation 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 economic incentive
for failing to report for the inventory. This is particularly
true since by reporting a person avoids the necessity for
premanufacture notification.
Failure by a manufacturer or importer to report on chemical
substances as required will be considered a serious violation based
on its effect on the ability of the Agency 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
Marufacturers, importers, processors and trade associations
are required to keep certain records as described in I.A.2.e
above. There is no major economic incentive for committing
this violation. Failure to keep such records will result in
a presumption that information submitted to the Agency is
inaccurate. Since the Agency must be able to rely on the
information submitted to carry out TSCA §5 as well as other
image:
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sections of the Act, failure to maintain records particularly
with respect to production years and use for a ccmmercial purpose
will be considered a serious violation.
e. Failure to Include All Information
Marufacturers and importers whose total annual sales
exceed $5 million itsjst report on production volume and whether
the chemicals is site-1imitated. There is no major economic
incentive for ccmmitting this violation unless it is to hide
an excluded substance. To the degree that the emission could
affect the success of the pranamfacture notification program,
it will be considered a major violation.
f. Failure to Report on Time
There is no major economic incentive for a failure to report
on time. Although late reporting is preferable to failure to
report at all, it remains a violation.
g. Clerical Errors, Internal Inconsistencies, Other Missing
Information
Reporting errors of a clerical nature will not be the
target of enforcement actions.
3. Compliance
a. Voluntary Compliance
An effective program aimed at informing the affected industry
of the inventory reporting requirements was undertaken by the
Office of Industry Assistance. The general public would have
little interest in this regulation.
Based on comments received daring the comment period for
the proposed regulations, national public interest groups
are well-informed of the requirements. Any additional
attempts to reach local interest groups should be confined
to discussion of the inventory as it relates bo §5 require-
ments.
b. Compliance Monitoring
1) Discovery Tools
Tools potentially available to EPA for discovery of violations
of the inventory reporting regulations include the following:
a) inventory data
b) non-inventory data bases on marufacturers arri importers
of chemical substances
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c) reports of violations
o from private individuals/ccrapanies
o from other government agencies
o frcm other EPA offices
d) on-site inspection/investigation
Of these, the on-site inspection/investigation is the only
tool which can be relied on alone as the basis for filing a
complaint. Generally, OE will have to monitor compliance
with the inventory reporting regulations by developing a
neutral inspection schedule based on indications of potential
violation from the inventory itself, random selection from
the inventory, outside allegations of violation and indications
of violation discovered in the course of other TSCA or EPA
inspections.
2) Application of Tools to Specific Violations
a) Reporting Excluded Substances
i) R & D Substances
EPA may select persons for inspection because it suspects
them of having reported a substance manufactured or imported
solely for research and development. Such a selection may
be made based on one or a combination of the following methods;
o OTS will select from the inventory any substances produced
or imported in quantities of less than 1000 lbs/year and
reported by known mamfacturers or importers of R & D
substances.
o OTS will select frcm the inventory those chemical substances
which were assigned new Chemical Abstract Service (CAS) numbers.
o OE will select frcm the National Enforcement Investigation
Center (NEIC) violation list (Appendix A) manufacturers
or importers reporting for the inventory who have a
history of violating other EPA reporting or registration
requirements.
o Informatics will compare the inventory with lists of
substances mamfactured prior to 1977 (see International
Trade Commission (I1C) and Stanford Research Institute (SRI)
lists in Appendix A) to isolate substances appearing on
the inventory but not listed elsewhere as having been
mamfactured prior to 1977. This method is of limited
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value for several reasons. There are no specific listings
for imported substances. Because the ITC listing excludes
substances produced in quantities of less than 5000 lbs.
and both ITC and SRI listing are incomplete, a failure
to appear one either list may not indicate a violation.
ii) Substances Not Manufactured, Processed, or Imported Since
January 1, 1975
To determine which substances reported for the inventory
might not have been manufactured or processed since 1975,
the inventory will be compared with ITC and SRI data for
1975, 1976, are! 1977. Informatics will make this comparison
arri transfer the results through PTSED to the regions for
further investigation.
Since these lists are incomplete, substances isolated may
not be in violation. A percentage of the manufacturers of
substances isolated, however, will be included in a regional
inspection schedule along with a random selection of importers
who reported for the inventory.
iii) Chemical Substances Used Solely for Non-TSCA Purposes
To isolate substances improperly 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 commission
(nuclear materials), FDA (foods, drugs, cosmetics) and OPP
(pesticides).
Chenical substances used in products regulated by these
agencies may also have other uses appropriate for regulation
under TSCA. Therefore, EPA would have to conduct inspections
to verify whether substances isolated in this manner have
reportable uses. This approach consumes more resources than
it merits given the potential rewards.
b) Reporting False Information
There are no complete or accurate public data available
outside the inventory on production volume per chemical
substance or on site limitation. The only way to discover
substantial variation from reported production ranges or false
reporting of site limitation is through bocks and records
inspections. OE could include manufacturers, processors
and importers in inspection schedules based on reports of
violation or random selections from the inventory.
c) Failure to Report at All
The most difficult violation to discover will be a
failure to report at all. Outside allegations of violation,
isolation of manufacturers or importers of chenical substances
reported for the revised inventory by users and processors
and a comparison of inventory reports with available listings
image:
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may yield some suspects for inclusion in the inspection
schedule. The available listings, to the degree that they
are useful at all, can only indicate possible violations.
Manufacturers
Manufacturers are listed by SIC code in the following
compilations (See Appendix A):
i) Dun and Bradstreet
ii) PTS/EIS
iii) OSHA
iv) PCS
Chemicals are listed by manufacturer in the following can-
pi lat ions:
i) SRI
ii) ITC
iii) ORD
None of these listings is complete and none makes a dis-
tinction between manufacturers and processors.
Failure to report by those who exceed the poundage
criteria will also be difficult to detect. The lists avail-
able for comparative purposes (I1C, ORD, SRI) are incomplete
arri generally indicate only production capacity not actual
production volume.
Sales figures are generally listed by chemical or chemical
group and not always by manufacturer (ITC, Dun and Bradstreet).
Although some sales figures by manufacturer are included in
the ORD list, this information is incomplete and is limited
to 400 organics which are likely to be included in the inventory.
Importers
To bring chemicals into the U.S. after premarufacture
notification requirements go into effect importers must sign
a certification indicating that each imported chemical substance
is in canpliance with all TSCA requirements.
To determine whether importers have unlawfully failed to
report, EPA will rely on Customs Inspectors to notify EPA
when entry forms do not contain the necessary certification.
Customs will hold the shipment or release it under bord
until certification is verified. If the importer cannot
supply documentary proof of compliance with inventory
requirements, the substance will be refused entry.
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Non-documentary verification of the accuracy of
certification will be more difficult. Actual sample analysis
of substances as a means of verification is expensive and
time consuming unless the basic identity of the substances
is known. Sampling/analysis will be restricted to cases
presenting a strong suspicion of violation.
d) Failure to Maintain Records
This violation can be discovered only through on-site
inspections.
e) Failure to Include All Information
To isolate those manufacturers and importers who have
omitted site and production data and are in violation because
they have incorrectly described themselves as small (total
annual sales of less than $5 million), Informatics could
ccmpare sales information in the Dun & Bradstreet and
PTS/EIS lists against information reported for the inventory.
Dun and Bradstreet and PTS/EIS list sales by manufacturer
and SIC code. A comparison might also be made with the
sales information for the 400 organics included in the ORD
list. All listings, hcwever, are incomplete.
To isolate an otherwise small manufacturer or importer
who should have reported production and site information
for a particular substance because it was manufactured
or imported in quantities of over 100,000 pounds, Infor-
matics could compare inventory production information
with production capacity data on the SRI lists.
Since all manufacturers/importers are not included in
the available lists and the information included is not
reliable, OE would have to inspect a percentage of those
persons whose forms have missing information as well as
those abcut whom OE has received allegations of violation.
f) Failure to Report on Time
OE will seardi for manufacturers and importers
who failed to report as required and whose substances
are being reported by processors during the revised
inventory reporting period in the following manner:
i) OTS will select a random number of processors
reporting for the revised inventory and turn the list
over to OE for further investigation.
ii) OE will request from each processor a certification
that he is not also a manufacturer of the substance.
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iii) If the processor is not a manufacturer of the
substance, OE will request a list of the processor's
suppliers.
iv) OB will contact each supplier and ask for certifi-
cation that he was not required to report for the initial
inventory (i.e., substance was not marufactured/imported
after January 1, 1975)
v) OE will conduct a routine records inspection of a
percentage of the suppliers identified.
vi) If OE finds an alleged violator, his name
will be turned over to the Premanufacture Review
Division at the same time case preparation is
begun to bring an enforcement action for violation
of the inventory reporting regulations.
g) Clerical Errors, Internal Inconsistencies, Other
Missing Information
Clerical errors, internal inconsistencies, or missing
information such as signatures, names and addresses, prin-
cipal technical contacts, registry nunbers, or EPA code
numbers discovered on the form are being handled by the
Chemical Abstract Service (CAS), iriiich has contracted
for the responsibility of compiling the inventory. When
such clerical mistakes are observed, CAS will either
return the form or communicate directly with the company
by letter. Should these procedures be unsuccessful in
resolving the matter, the appropriate EPA Regional Off ice
could be called in to assist. As indicated earlier,
reporting errors of a clerical nature will not be the target
of enforcement actions.
3. Priority Compliance Monitoring Activities
Since a major function of the inventory is to act as a trigger
for the premanufacture notification process, OE will place its
major emphasis on those ccmplianoe monitoring activities 1)
designed to insure the integrity of this function and 2) which
can reasonably be undertaken given available resources (see
II.B.3.b.2)). With this purpose in mind, compliance monitoring
activities in order of priority are:
a) those designed to detect inclusion of R & D substances.
b) those designed to detect inclusion of substances not
manufactured since January 1, 1975.
c) those designed to detect failures to report on time.
d) those conducted in response to reports of any of the
inventory reporting violations.
image:
Subjects will be selected for compliance monitoring on
the basis of the neutral inspection schemes described in
(II B.3.b.2)).
Thorough compliance monitoring prior to initial inventory
publication would ideally insure the integrity of the published
inventory as a §5 trigger and prevent confusion resulting from
post publication deletions. Practically, OE can do little to
enforce the inventory prior to initial publication.
OE will conduct its inventory enforcement program primarily
during the period between publication of the initial inventory
and publication of the revised inventory.
The following table indicates the emphasis OE will place on
inventory reporting compliance monitoring activities after
inventory publication.
% Allocation of Resources Available for Inventory Enforcement
1Stage
CM Activity
% of Total Resources I
I After Initial
I Inventory
|Publication
Affirmative CM for
R&D Substances
Affirmative CM for
Substances Not
Manufactured or
Imported after 1975
40% |
30% |
Affirmative CM for
for Late Submissions
20% |
Responsive CM to
Reports of Other
Violations
10% |
IAfter Revised
I Inventory
I Publication
Affirmative CM for
R&D Substances
Affirmative CM for
Substances Not
Manufactured or
After Imported 1975
Responsive CM to
Reports of Other
Violations
100% |
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III. Strategy Implementation
A. Program Management
1. Allocation of Responsibility
The following table summarizes the allocation of responsibility
for management and implementation of the inventory enforcement pro-
gram.
| Headquarters | |
1 PTSED I OTS | Regions I
1
1 R & D Substances
1 1 1
1 1 1
1 1 i
1
I o Select Subjects
|
i 1 l
X i X | 1
1 1 1
I
I o Notify Regions
|
1 I 1
x| I 1
1 1 1
1
| o Conduct Inspections
1 1 1
1 I X I
1 1 1
I
I o Prepare Cases
I 1 1
X* I | X* 1
1
I Substances Not
I Manufactured or Imported
I After 1975
1 1 I
1 1 1
1 1 1
I 1 1
1 1 1
1
I o Select Subjects
1
1 I 1
x 1 X | 1
I 1 1
1
1 o Notify Regions
I
1 1 1
XI I 1
1 1 t
1
I o Conduct Inspections
1
J ' I
1 1 X 1
1 1 1
I o Prepare Cases
1 I 1
1 1 X I
1
I Reports of Violation
I
1 1 1
1 1 1
1
I o Investigate Reports
i
1 1
XIX 1 X 1
1 1 1
i
| o Conduct Inspections
i
1 i 1
I 1 X 1
1 ( 1
i
I o Prepare Cases
' ' 1
X* 1 1 X 1
1
| Late Submissions
! 1 1
1 1 1
I o Identify Subjects
1
I 1 -1
x 1 X 1 I
1 1 1
I
I o Send Notices
t
x | 1 1
1 1 1
1
I o Conduct Inspections
' 1
1 1 X 1
1 1 1
1
I o Prepare Cases
1 !
1 1 X 1
headquarters will take over case preparation for R & D substances
where 1) more than one region is involved or 2) the R&D determination
is a complex one.
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The allocation of responsibilities illustrated in the table is
based on a) special expertise, and ease of access to data, and b)
resources required for a given activity compared with c) resources
actually available.
a. Special Expertise and Ease of Access to Data
Headquarters OE will be responsible for working with
OTS to select subjects for compliance monitoring activities
because of the greater ease of access to inventory data
as well as other data required in making the selections.
b. Resource requirements
Resources will be required for selecting subjects from
inventory and non-inventory data bases, for inspection/
investigation, and case preparation as follows:
1) Selection of subjects
a) Inventory data
OE will use several approaches to select candidates
for inspection frcm data submitted for the inventory:
i) EMring the revised inventory reporting period,
OTS will forward to QE on a monthly basis a list
of processors who have reported. OE will go through
the steps described in II B. 3. b. 2) f) to determine
whether any of the suppliers of the processors are
in violation of the inventory reporting requirements.
Selection of processors by OTS will require approxi-
mately 2 weeks. Further follow-up by OE Headquarters
prior to inspection by the Regions will require
approximately 2 weeks.
Informatics One month after publication of the
initial inventory, a complex computer system will
be available to OE for selection of inspection
candidates. OE can request candidates based on any
of the parameters reported for the inventory with a
turn around time of 2 days.
b) Nort-inventory data bases
Date available to OE outside of the inventory are
limited and not extremely reliable. (See Appendix a
for description of data sources.) While there are a
number of listings of importers, there is no compre-
hensive listing of specific chemical substances by
importer. Information on manufacturers is also poor
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and makes no distinction between manufacturers and
processors. As a result, establishment of a complete,
reasonably accurate industry profile for comparison
with the inventory reporting data is not possible.
The limited data which are available could be used as
a starting point in selecting manufacturers and
importers for inclusion in an inspection schedule only
for select violations as indicated in (II. B. 3.b.2)).
OE can expect a turn around time of 2 days to obtain
a list of inspection candidates from any non-inventory
data base on computer tape and available within EPA.
If a non-inventory computer tape must be compared with
the inventory, it may take as long as two weeks to
obtain results. If non-inventory data is available
only in bound form,the tine required to obtain a candi-
date list will be 2 days for inventory printout and at
least 2 weeks by OE personnel or a contractor to make
the manual comparison.
2) Investigation/inspection
OE will have to investigate any substantive reports of
violation before instituting any enforcement action.
Resources required will range from those required for
writing a letter to the alleged violator requesting clari-
fication of the circumstances to those required for an
on-site inspection.
The following elements were considered to determine
resource requirements for establishment inspections:
o preparation time
o travel time
o books and records inspection
o inspection report preparation
Requirements per inspection will vary with differences
in travel time, the complexity of the potential violation
being investigated, and the experience of inspectors in
conducting this type of inspection. Given these variables,
PTSED feels that an average inspection will require 5 days.
3) Case Preparation
Case preparation will vary depending on whether a case is
settled or goes to a hearing. PTSED estimates that case pre-
paration through settlement will require 15 days while case
preparation through a hearing will require 15 days for write-
up and 15 days for litigation (a total of 30 days.)
It is estimated that violations will be discovered in 10%
of the inspections conducted. Of the resulting cases, it
is estimated that 85% will be settled while 15% will go to
a hearing.
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d. Application of available resources to strategy
resource requirements
Based on the fiqures contained in the preceding section
(III.A.l.b.) and the resources available in FY79 and FY80,
the following calculation can be made to summarize the scope
of the inventory reporting enforcement program in FY79 and
FY80.
30 workdays =
10 Workdays =
5 workdays -
220 workdays -
4 workyears =
3 workyears =
X
.10 X • =
(.10X)(.85)(15)=
(.10X)(.15)(30)=
Headquarters inspection schedule
development FY 79
Headquarters inspection schedule
development FY 80
one inspection
one work year
resources available in FY79
resources available in FY80
total lumber of inspections
number of case preparations
number of case preparations
for settlement
number of case preparations
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 also be responsible for any case
preparation resulting frcm the inspections. Regions should,
however, adhere to the Concurrence Procedures (See March 27, 1979
memo to Regions) prior to proceeding with any case. These pro-
cedures are particularly important to insure a consistent approach
in cases involving an R & D substance since the definition for
such a substance may be subject to varying interpretations.
In cases where classification of a substance as R & D is
genuinely open to dispute, Headquarters will take over the case.
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2. Need for Delegation of Authority and Confidentiality
Clearance
All Regions have authority to conduct inspections under TSCA.
Currently, however, Regions do not have adequate enforcement
personnel cleared to access and copy confidential information
in the course of an inspection or to access confidential data
reported to EPA which may be necessary for adequate case pre-
paration. If sufficient Regional personnel do not receive con-
fidentiality clearances, the inspection and case preparation
responsibilites must shift to Headquarters.
B. Outreach
Headquarters will be responsible for implementing Outreach as
described in II. B. 3. a.
C. Compliance Monitoring Program
Once OE has selected subjects for compliance monitoring, an
onr-site inspection will be used as the most effective tool for
discovering violations. Before the inspection program can proceed,
the following issues must be addressed:
1. Confidentiality
Because it is quite likely that inspectors conducting
a §8(b) inspection will need to gain access to information
claimed confidential, all inspectors must have a security
clearance from the Office of Toxic Substances.
Inspectors must be thoroughly familiar with procedures
in the TSCA Confidential Business Information Security Manual.
Conf idential data reviewed and collected as part of an inspect ion
must be treated with the same strict security measures as con-
fidential data submitted to the Agency under TSCA reporting
requirements.
2. Training
All TSCA inspectors should be familiar with basic principles
of chemistry. No advanced training in diemistry, however, is
necessary for conducting inspections related to inventory reporting
requirements.
Inspectors must be thoroughly familiar with the Inventory
Reporting Regulations, the Inventory Enforcement Strategy, and
the procedures for conducting TSCA inspections as outlined in the
PCB Inspector's Manual and Appendix C of this Strategy. There
will be no need for sample collection.
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3. Inspection Sites
Since it is likely that ccmplete records will be kept at
corporate headquarters or a company's major business office,
the initial inspection should be conducted there. If necessary,
additional inspections may be required 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 and records inspection. The determination that a
substance has been reported in violation of the R&D exclusion
will be more difficult. A substance may be initially presumed
by EPA to be an R & D chemical because it is produced in
annual quantities of less than 1000 lbs. and there is no
other public information available to indicate that it has
been produced for a commercial purpose. While a books and
records inspection may not clearly rebut or affirm this
presumption, the following considerations should be kept in
mind:
Pre-Revised inventory Publication
o A manufacturer must be able to produce clear evidence
that a substance is used for commercial purpose.
Sale of a substance is not enough alone to justify
its classification as a reportable substance in
commercial use. A manufacturer must be able to pro-
duce, documentation such as letters from customers
certifying that the chemical in question is being used
for purposes other than research and development.
o A company must use consistent criteria for distinguishing
R&D from test market and other commercial substances.
EPA should honor these criteria as long as the company 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 and another set to justify
exemption of a substance from premarufacture notification
requirements under §5(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
individual. A person who because of his training, educa-
tion or experience 1) is able to appreciate the health &
safety aspects of the substances used under his supervision;
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2) is responsible for enforcing methods of scientific
experimentation, analysis, or chemical research to
minimize such risks and 3) is responsible for safety
assessments and clearances related to the procurement,
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 manufacturer 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
commercial 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 which the inspector
believes he found during the inspection and shall describe
all relevant supporting evidence. After completing the
Inspection Report, he shall submit that document, the Vio-
lation Worksheet, a copy of his applicable Field Notes arti
other relevant supporting documents to the case preparation
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.
D. Enforcement Proceedings
Regional enforcement officials shall examine each Inspection
Report and any other relevant material submitted by the inspector
and make the following determinations:
1. Is there a probable violation?
2. If so, what type of enforcement action, if any, should
be brought?
3. Against whom should the enforcement action be brought?
4. If the enforcement action is one for administrative
civil penalty assessment, how much should the proposed
civil penalty be?
Guidelines for makinq each of these determinations are
provided below:
1. Determination that a Violation Exists
Each failure by a person to ccmply with a specific inventory
reporting requirement for a single chemical substance shall
constitute a separate violation. To determine whether a probable
image:
- 23 -
violation exists, the case preparation officer shall consult the
Violation Citation Charges (Appendix D) and Evidence in Support
of Charges (Appendix E) and compare them 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 charge. 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 wili support a violation charge, he/she will
transmit the material to the Regional enforcement attorney who
will determine what enforcement action should be brought against
the alleged violator.
2. Selection of Proper Enforcement Action
The Agency may bring a number of enforcement actions
against an alleged violator. The Agency may:
a) issue a notice of non-canpliance
b) assess an administrative civil penalty
c) institute a civil court action
d) institute a criminal court action
To determine what general level of enforcement action would
be appropriate for the violation standing alone, the enforcement
attorney shall consult the Violation Charges/Action Levels (Appendix
0) and Evidence in Support of Charges (Appendix E). Thereafter,
the enforcement attorney shall determine what specific enforcement
action should be selected by considering the following criteria.
Nbtice of Non-compliance
A notice of non-compliance may be issued where:
1) the violation does not impede the Agency's ability to
enforce the premanu.facture notification requirement,
2). the violation affects the accuracy of the chemical
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 inventorv
reporting regulations, and
4) the violation does not appear to have been willful.
image:
- 24 -
A notice of nort-ccmpliance should be issued only if the
enforcement attorney determines in his/her discretion that
the violation passes these tests and that the issuance of a
notice of non-ccmpliance will be sufficient to induce the
violator to cease violation of the regulation in those
respects stated in the notice of non-compliance.
Administrative Civil Penalty
Mcst violations will be handled by administrative civil
penalty assessed according 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-
ment of'an a3ministrative civil penalty, if the alleged violator
ignores the civil penalty.
Criminal Court Action
Criminal action will be recommended 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 premanufacture
notification system.
3. Liability
The Inventory Reporting Regulations define "persons"
to include individuals as well as corporations, partner-
ships or associations. In taking enforcement action to
redress violations of these regulations, therefore, EPA
generally has the cption 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 employees. The Agency,
however, reserves its right to impose individual liability
under appropriate circumstances. If EPA brings an action
against a partnership or an unincorporated association, the
partners/members will, of course, be jointly and severally
liable. (Depending on whether the "entity" or "aggregate"
theory of partnership prevails in a given state, EPA will
have to name the partnership or the partners to ensure the
validity of its complaint.)
In an action against a totally or partially owned
subsidiary, EPA may join any parent company which plays
a substantial role in the business affairs of the subsidiary.
image:
- 25 -
4. Civil Penalty Assessment Procedure
a. Threshold decision and ccmplaint
Once the enforcement attorney has determined that a civil
penalty is warranted, he/she must prepare a Ccmplaint 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 diarges contained in the ccmplaint.
b. Independently Assessable Charge
A separate civil penalty shall be assessed only for
each violation of the inventory reporting regulations
which results from ah independent act (or failure to
act) of the respondent and which is substantially dis-
tinguishable from any other charge in the ccmplaint.
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 ccmplaint
will be separately assessed. For example, a manufacturer
may falsely report a large production volume to hide the
fact that he is reporting an R & D substance for the
inventory. He would be charged with two violations:
reporting false information and reporting an excludable
R&D substance. However, since the second charge grows
cut of the first, the manufacturer would be assessed a
civil penalty only for reporting an excludable substance.
c. Civil Penalty Assessment System
A civil penalty system for use by EPA in implementing
TSCA is currently being developed under contract. The
civil penalty assessment system is composed of two elements:
A Gravity Base Penalty (GBP) which provides a method of
assigning penalties to violations based on their seriousness;
and Adjustment Procedures which provide a method of adjusting
the Gravity Base Penalty bo account for mitigating and/or
exacerbating factors related to the violator.
Under this system violations of TSCA have been grouped
into two major categories: control violations—those
involving mishandling of a regulated chemical substance an3
data gathering violations—those involving failure to adhere
to a monitoring, recording or reporting regulation. Data
gathering 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 developing information needed to
assess the threat of a new or existing chemical substance.
image:
- 26 -
Violations of the Inventory Reporting Regulations
fall into the category of non-associated data gathering
violations. The overall TSCA penalty system has been
developed around violations of regulations of a chemical
substance and must be adapted somewhat to accommodate
violations of non-associated data gathering regulations.
The basic structure and guidelines, however, do provide
the required approach.
i) Gravity Base Penalty
The major modification of the overall TSCA civil
penalty assessment system to suit inventory reporting
violations occurs in the assignment of the GBP.
Generally EPA will use a Gravity Base Penalty Matrix
(Appendix F) to determine the GBP amount for a vio-
lation of TSCA. OE has modified this GBP matrix in
two respects to accommodate the inventory reporting
regulations.
Penalty amounts in the GBP matrix have been
assigned based on the seriousness of the violation.
Two parameters are used to established the severity
of a violation: extent of damage and potential that
damage will occur. For inventory reporting violations
the extent of the violation defined by the section
of TSCA affected and the potential damage by the
potential that the violation will seriously affect
implementation/ enforcement of the TSCA section.
In addition the GBP matrix has been modified to
eliminate as inapplicable the "Significant" level
from the "Extent of Damage" indicator and the "Mid-
ranqe" level from the "Potential Damage" indicator.
The following is a description of the measures of
"extent" and "potential" for violations of inventory
reporting regulations.
/EXTENT/
Major - A major violation is one that affects the
premarufacture notification requirements.
Minor - A minor violation is one that cculd affect
sections of TSCA other than §5.
/POTENTIAL/
High Range - The violation directly affects EPA's
ability to enforce or implement a TSCA
requirement.
Lew Range - The violation results in a lack of
data which is important but not critical
to TSCA enforcement or implementation
procedures.
image:
- 27 -
p?ig<ari on consideration of the above-mentioned
factors the following GBP's are suggested for each of
of the potential inventory reporting violations. (See
Appendix D for potential action levels in addition to a
complaint.)
o Reporting Excluded Substances:
Extent of Damage
Major - The report affects the Agency's premarufacture
notification requirements.
Potential for Damage
High - If an excluded substance is reported for
the inventory, EPA will not be able to
implement or enforce the §5 requirements
with respect to the substance.
QBP « $25,000
o Reporting False Information:
Extent of Damage
Major - The false information affects the
premarufacture notification requirements.
Minor - Hie false information affects sections
of TSCA other than §5.
Potential for Damage
High - The false information results in the
inclusion of an excluded substance and
thereby affects EPA's ability to enforce
or implement §5.
Lew - The false information results in lack of
data used to select chemicals for further
study.
GBP
Major/High - Uie GBP will be assessed under the
violation for reporting an excluded
substance. Mb separate GBP will
be assessed for false reporting.
Minor/Low - $250
image:
- 28 -
o Failure to Report
Extent of Damage
Major - The failure to report affects implementation
of §5 because the substance has been
reported by no one.
Minor - The failure to report potentially affects
only implementation of other sections
of TSCA because the substance was reported
by someone else.
Potential for Damage
High - It may result in needless pre-
manufacture notification by other
manufacturers.
Low - It results in a lack of data for use
in selection of chemicals for further
study.
GBP
Major/High - $25,000
Minor/Low - $250
o Failure to Maintain Records
Extent of Damage
Major - Hie failure to maintain records for
production years and use for a
commercial purpose could affect
implementation of section 5.
Minor - The failure to maintain records could
affect implementation of TSCA sections
other than section 5.
Potential Damage
High - The lack of production and commercial
use records cannot be compensated by
other information to substantiate
reporting of a non-excluded substance.
Low - In most cases lack of records can be com-
pensated with other information and will
result only in a lack of substantiation
for data which is important but not critical
to EPA selection of substances for further
control.
image:
- 29 -
GBP
Major/High - Hie GBP will be assessed under the
violation for reporting an excluded
substance. NO separate GBP will be
assessed for failure to .maintain records.
Minor/Lew - $250
o Failure to Include All Information
Extent of Damage
Major - The failure affects premarsufacture 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.
GBP
Major/tiigh - The GBP will be assessed under the
violation for reporting an excluded
substance. No separate GBP will be
assessed for failure to include all
information.
Minor/Lew - $250
o Failure to Report in Time
Failure to report on time will be considered
under two time frames - before initial inventory-
publication and after initial inventory publication*.
Before Initial Inventory Publication
No GBP
Untimely reporting theoretically affects the
integrity of the inventory as a basis for pre-
manufacture notification. In fact, however, as
long as reports were received in time to he included
in the initial inventory, the Agency will be able to
implement §5 properly.
image:
- 30 -
After Initial Inventory Publication
After initial inventory publication, the violation
automatically changes to Failure to Report and should
be handled under those guidelines.
o Clerical Errors
EPA will take no enforcement action against
mere clerical errors.
ii) Adjustments Factors
All the rules and procedures presented in the
overall TSCA Penalty Policy for adjustments should be
applied to the GBP for inventory reporting violations.
d. Computation of the Civil Penalty
Dav of Violation Defined Since the inventory reporting
regulations establish specific deadlines for compliance, the
duration of any violation discovered cculd be computed from
the deadline of the date of compliance. Sudi an approach,
however, would result in unduly harsh penalties. Therefore,
for purposes of computing the civil penalty for an inventory
reporting violation, the day of violation will include only
the day of discovery.
e. Worksheet
The Civil Penalty Assessment Worksheet (Appendix H) shall
be used to compute the proposed civil penalty and to record
any subsequent adjustment to the proposed amount. The
Worksheet serves as a guide to the Agency in arriving at
a final civil penalty, and as a memorandum of the Agency's
deliberations concerning the violations cited. The Worksheet
need not be sent to the respondent as part of the ccmplaint
but should be made available to him upon request. Detailed
instructions for computing the proposed penalty and completing
the Worksheet appear in Appendix G.
E. Program Integration
1. TSCA Programs
a. Impact of Violation
Only two violations will have a major direct impact on
other TSCA implementation and enforcement programs. Reporting
of an excluded substance or a failure to report at all will
impact implementation and enforcement of the §5 premanufacture
notification requirements.
image:
- 31 -
b. Communication Mechanism
1) The Regions will notify OE Headquarters of potential
enforcement actions for either of the above-mentioned
violations through the Concurrence Procedures.
2) If OE Headquarters concurs in the action, it will
notify OTS of the pendency of the action and will confer
with OTS to determine whether the circumstances of the
alleged violation warrant:
a) premanufacture notification including
a halt to production for 90 days and a
civil penalty for violating the inventory
reporting requirements, or
b) premaru facture notification with no
halt in production and a civil penalty, or
c) premanu facture notification with or
without a halt to production and a notice of
nort-ccmpl i ance
d) a civil penalty.
3) OE will notify OTS of the outcome of the
enforcement proceeding.
4) A reported substance which was excluded frcm the
inventory but which is being manufactured or imported
at the time the violation is discovered is subject
to the premarufacture notification requirements as is an
eligible substance for which no report was submitted to
EPA. When premarufacture notification is required, OE
Headquarters will check with OTS to ensure that §5
procedures have been initiated by the violator.
5) A person who reported an excluded substance but is
not manufacturing/importing it at the(time the violation
is discovered will face a civil penalty and removal of
the substance from the inventory. OE/OTS will announce
removal 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
monitoring 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 monitoring activities will be of little
value to other EPA enforcement programs.
image:
APPENDIX A-l
DATA SOURCES; Suimary
Data Hamfacturer
Distinction
Processor
Importer
Name & Address
Listing
by
SIC Code
listing
by
CAS ft
Listing
by
Chemical
Listing by
Chemical
Group
Listing
Chemical
Group
Production
Volume/
Capacity
"Total
Sales
Previous
Sales/ EPA
Chemical Violation
Source
[>m art!
vea
no
no
no
no
no
gross
sales
no no
Brartstreet
Irriustry
assistance
ves
no
no
no
no
no
no
no
no no
yes
no
no
no
incomplete
yes
by chemical oc
yes chemical qroup
no
chemical group
(not by manufacturer) no
1TC
OKP
no
yes
400 orqanics
no
no
incomplete
inoanplete incomplete no
"
yes
no
no
no
no
no
no
no no
OS'lA
yes
no
no
no
no
no
ves
no no
PTS/E1S
no
ves
10,000
no
no
no
no
no no
SRI
(Jf.IC violation
ves
no
no
no
no
no
no
no yes
List
Customs
no
no
no
by
Customs
regions
yes
broad
cateqories
no
no
no no
Rareau TSUS
AM. Importers
Assn. Directory
1200 brokers
no
no
no
general
categories
of imports
onlv
general
categories
of imports
onlv
no
no
no no
Reqister of
&n. Importers
fc Exporters
no
no
35.000
no
no
no
general
categories
of imports
only
general
categories
of imports
onlv
no
no
no no
image:
A-2
Data Sources
Manufacturers/Chemical Substances
Name
Subject Coverage
Coverage
Date
Update
Frequency
Availability
Comments
Dun & Bradstreet
.U.S. firms by SIC code
. gross sales
1859-present variable
EPA/OPE
Steve Weil
755-2770
. no distinction
between manu-
facturer/pro-
cessor
. no production
figures
. no listing by
chemical sub-
stance
. data not reg-
ularly updated
& often inaccurate
Industry Assistance
. manufacturers
continual
Office of
. based on D&B, write-
List
. importers
Industry
ins, etc.
. trade associations
Assistance
. no production, sales,
. law firms, consultants
Joe Boyle
or SIC data
etc.
755-3852
41,000 entries
International Trade
Commission (ITC)
"Synthetic Organic
Chemicals - U.S.
production and
Sales"
. domestic production (by
original manufacturers
only) and sales of
synthetic organic
chemicals and raw mate-
rials from which they
are made
. generally minimum pro-
duction volume reported
is 5,000 lbs.
. minimum sales value is
$5,000
. items listed by primary
manufacturer
. alphabetical listing of
reporting manufacturers
and their addresses
. data supplied by 800
producers
1916-present annual
Hard copy in
EPA Library
Computer
access through
Steve Heller
OPM/54938
statistics for
chemical or group
are given only when
there are 3 or more
producers and there is
no possibility of
violating confiden-
tiality
all manufacturers are
not listed by chemi-
cal substance
image:
A-
Manu facturers/Cherai cal Subs tances
Coverage Update
Name Subject Coverage Date Frequency Availability Comments
ORD
. 400 organic chemicals variable
variable
Cincinnati
. does not contain
Orqanic Chemical
listed by CAS #
IERL
carpiete product
Producers Data
may include:
Dave Becker
slate for every
Base
. total chemical
(8) 684-4481
plant
production & prices
. inorganic & small
. site specific pro-
volume of specialty
duction capacity
chemicals are not
addressed
. data is not uni-
formly available
for all listings
. will probably be on
inventory
OSHA-Irvdustry List
. name and address of all
variable
OSHA
. no information on
firms inspected
Susan Nelson
production or sales
. 4 digit SIC codes
Office of
. no distinction
. ranked by injury severity
Policy and
between manufacturers
Analysis
and processors
Integration &
Evaluation
Roan 4605 or
Jack Ratalinas
Heerf, Mgmt.
Info. System
Rm. 3700
523-7115
PTS/EIS Plants
. U.S. firms with more than 20
revised
NEIC
. no distinction
employees, annual sales over
quarterly
Doug Seba
between manufacturers
$500,000
(8) 234-5306
processors :
. 4 digit SIC codes
. no breakdown by
. sales by plant in category
specific chemical
. county by county
substance
. market share
. no production volume
117,000 citations
. no sales data per
chemical substance
image:
A-4
Manufacturers/Chemical Substances
Name
Subject Coverage
Coverage
Date
Update
Frequency
Availability Comments
Stanford Research
Institute (SRI)
"Directory of
Chemical
Producers"
10,000 chemicals
manu facturers
production capacity
OPE
annual Judy Nelson
(1977)
Betty Johnson
(415) 326-6200
X-68627
availability
only in
hardback
no distinction
between manufacturer
processor
no actual production
volume
no sales information
image:
A*-5
Importers/Chemical Substances
Name
Customs Bureau
TSIJS
Subject Coverage
Coverage
Date
Update
Frequency
Availability
Comments
American Importers
Association
Directory
American Importers
and Exporters
Directory
listing by broad
chemical categories
(TSUS #)
regional fiqures on
import volume arid
price
annual Available but
no ready access
because of
confidentiality
cons iderat ions
1200 members-brokers
importers
annual available PPSED
Ted Rowan AADA
(212) 490-2723
35,000 names
no listing by
chemical sub-
stance
no listing by
manufacturer
no sales figures
by manufacturer
or chemical sub-
stance
, lists only general
categories of
irnports
1974 ed. in
library
PTSED has on order
inaccurate
listing only by
general categories
i.e., ferilizers
image:
A—6
Substances Not Regulated Under TSCA
Coverage Update
Name Subject Covered Date Frequency Availability Comments
OPP/EPA
. reqistered pesticides
current
Elgin Fry
need active
name
Paul Cassy
ingredients,
. registrants
69430
not products
FDA current Food
Ralph Strand
245-1567
Drugs
Winston Cobb
427-8171
image:
A-7
EPA Violation Information
Name
Air Compliance
Data System
Subject Coverage
Coverage
Date
Update
Frequency
Availability
Comments
Violations listed by:
. point source
. SIC code
. county
1972-present variable
Stationary
Source
Enforcement
Division Hq's
Frank Smith
755-0103
no distinction
between manufacturers
& processors
PCS
. facility locations for
permit holders
. SIC code
. permit information
variable
Water
Enforcement
Bill Milligan
755-0991
no violations listed
PEMS . manufacturers by estm. # 1974-present variable PTSED
. by state
. by violation
NEIC List Listing of violators of current NEIC-Denver working on compreherv-
other EPA regs. by SIC Doug Seba sive listing available
code to PTSED for selection
of firms for inspection
schedule
image:
Additional
k-8
Information Sources
Name Subject Coverage
Coverage
Date
Update
Frequency Availability
Comments
Census Bureau
not available to
PTSED
Confidential
Interstate Commerce
Commission
not available to
PTSED
Confidential
image:
Jdix B-l
Violation; Reporting Substances Excluded from the Inventory
R&D Substances
Regulatory Requirements
Inspection Procedure
Documentation
§710.4(c)(3)
Any chemical substance marufactured,
processed, or imported solely in small
quantities for research and development
as defined in §710.2(y) is excluded
from the inventory.
§710.2(y)
Smal1 quantities for research and
development are defined as:
1) quantities of a substance no qreater
than reasonably necessary for purposes of;
. scientific experimentation on;
. analysis on;
. chemical research 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
manufactured, imported or processed in
quantities of less than 1000 lbs. are
for R&D purposes.
A person reporting a substance produced
in such quantities has the burden of
certifying that it is not for R&D.
Ask for the company's criteria for
determining whether a chemical subs-
tance is to be classified for R&D.
Ask vhat specific procedures are
involved in developing a test market-
ing program for a chemical substance.
Ask for company documentation in
support of non - R&D classification
for this particular chemical substance
Ask to see production records for
the chemical substance from the first
year of production.
Ask to see sales records for the
chemical substance from the first
year sales took place.
Ask to see records listing buyers.
Ask Co to produce correspondence
from customers demonstrating that
the substances has been commercially
distributed or is in test marketing
phase.
Make copy of written criteria.
If written criteria are not avail-
able, obtain a statement from a
responsible official outlining the
criteria and attesting to their use
by the company.
Make a copy of written procedures.
If no written procedures are avail-
able, obtain a statement from a
responsible official outlining the
procedures and attesting to their
use by the company.
Make a copy of any documentation
If no documentation is available,
obtain a statement from a re-
sponsible official outlining
specific support for the company's
classification of the substance.
Make a copy of production records.
Make a notation in the field book
of production records which
available.
Make a copy of sales records.
Make a notation in the field bock
of sales records which are not
available.
Make a copy of names, addresses
and phone numbers for later veri-
fication of the quantity of the
chemical substance sold and the use
of the chemical substance by the
buyer.
image:
B-i4
R&D continued
Regulatory Requirements
Inspection Procedures
Documentation
Ask to see records indicatinq size
and rurrber of production site(s) for
the chemical substance.
Ask to see records indicatinq the in-
ternal use to which the chemical is
put if not sold.
Ask to see any advertisments regarding
the use of the substance.
Ask about the educational background
and present professional duties of
any person in charge of use or
distribution of the substance.
(after publication of revised
inventory)
Make a copy of available records.
Make a notation of observations
in the field book if any on-site
visit is make.
Make a copy of available records.
Obtain an affidavit certifying
this use from a responsible
company official.
Make a copy of any advertisements.
, Make a notation in the field
book if no advertisements are
available.
. Obtain a statement from a
responsible company official
as well as the person in
charge of the use or distri-
bution of the substance at-
testing to that person's
education and professional
responsibilities.
image:
B-3
Violation: Reporting Substances Excluded from the Inventory
Substances Not Manufactured, Processed, or Imported Since January 11, 1975
Regulatory Requirements Inspection Procedure Documentation
§710.4
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 records or (for
importers) purchase records for the
chemical substance frcm 1975-1977.
. Ask to see sales records for the
chemical substance from 1975-1977.
. Ask to see records listing buyers of
the chemical substance frcm 1975-1977.
. Ask to see records of use if the
chemical substance is not sold.
. Ask to see advertisements regarding
sale or use of the substance from
1975-1977.
. Make a copy of available records.
. Make a notation in the field book
of periods for which there are no
such records.
. Make a copy of available records.
. Make a notation in the field bock
if there are no sales records.
. Make a copy of names, addresses,
and telephone nuntoers for veri-
ficiation of the year and the
amount of the sale.
. Make a copy of records indicating
internal use.
. Obtain a statement certifying
internal use from a responsible
company official.
. Make a copy of advertisements.
. Make a notation in the field bode
if no copies of advertisements
exist.
image:
B—4
Violation: Reporting Substances Excluded From the Inventory
Chemical Substances Requlated Under Other Acts
Regulation Requirements
Inspection Procedure
Documentation
§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 suhstance" does not
include:
(1) Any pesticide when manufactured,
processed or distributed in commerce
as a pesticide.
(2) Tobacco or any tobacco product, but
not including any derivative products.
(3) Any source material, special nuclear
material, or by product material.
(4) Any food, food additive, druq,
cosmetic, or device, when manufactured,
processed, or distributed in commerce
for use as a food, food additive, druq,
cosmetic or device.
Ask to see records substantiating
a use that does not fall into the
excluded categories.
Ask to see advertisements regarding the
non-excluded use of the substance.
Ask to see records listing buyers who
use the substance for a non-excluded
purpose and correspondence demonstrating
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 copy of the records
Obtain a statement certifying
the use from a responsible
company official.
Make a copy of any advertisements.
Make a notation in the field
bode if no such advertisements
are available.
Make a ccpy of addresses and
phone numbers for later veri-
fication of the non-excluded
use.
, Make a copy of the records
, Make a notation in the field bock
if information is not available.
, Make a copy of any records dis-
tinguishing between amounts of the
chemical substance produced for
excluded and non-excluded uses.
, Make a notation in the field
bode if the information is not
available.
image:
"0-5
Violation; Reporting False Information
(Production Volume/Site Limitation)
Regulatory Requirements
§710.5
Manufacturers and importers (other than
small manufacturers or importers) who
are required to report must report in
addition to:
. the identity of the chemical
substance
. monomers used at qreater than
2% (by weight) in the manufacture of
the polymer; and
. whether the substances reported are
manufactured/imported (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,
• the amount manufactured
at each site or imported
during 1977.
Inspection Procedure
. Ask to see records indicating the
number and size of production sites
. Ask to see production records for the
chemical substance fran 1975-1977.
. Ask to see sales records for 1975-1977
. Ask to see a list of buyers.
If you suspect that an R&D chemical has
been reported follow the additional
procedures outlined in B-1,2.
Documentation
. Make a copy of available records
If records are not available,
make notation of this in the
field book.
. Make copy of records.
Compare this information with data
indicating the mirtoer and size
of production 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 phone numbers for later
verification of sales.
image:
B-6
Violation: Failure to Report At All
Regulatory Requirements
Inspection Procedure
Documentation
§710.3(a)
Domestic manufacturers and importers
nust report for the initial inventory
concerning all chemicals they manufacture
or import for a commercial purpose in
1977 if:
1) 30% or more, by weight, of the pro-
ducts they manufacture or import consist
of the types described under Standard
Industrial Classification (SIC) Groups
28 or 2911, or
2) the total pounds of reportable
substances equal one million pounds or
more per site for manufacturers
(even if not in SIC 28 or 2911)
3) the chemical substance was manu-
factured or imported in quantities
qreater than 100,000 pounds.
§710.3(c)
Processors and users of a chemical
substance for a conmercial purpose
are not subject to initial inventory
requirements.
Ask to see records supporting failure
to report
Ask to see production records
for all substances manufactured
in 1977.
Ask bo see records of total amount of
chemical substances imported in 1977.
Make a copy of any records
Make a notation in the field
bock of any recoards not avail-
able.
Make a copy of records in-
dicating that 30% by weight
of the chemical substances
are in SIC code 28 and 2911.
Make a copy of records indicat-
ing total reportable chemical
substances manufactured or im-
ported is one million pounds or
more.
Make a copy of records indicating
that any chemical substance is
manufactured or imported in
quantities greater than 100,000
pounds.
Make a notation in the field
bock if any of the above
mentioned records are not
available.
image:
B-7
Violation: Failure to Maintain Records
Regulatory Requirements
Inspection Procedure
Documentation
§710.1(c)
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
such records by EPA officials.
Ask to see records substantiating
all information required to be
reported for a chemical substance
. identity
. monomers used at qreater than
2% (by weight) in the
manufacture of any polymer
whether manufactured, pro-
cessed or imported.
. production site(s)
. vhether site-limited
. amount manufactured at
each site or imported
during 1977.
. Make copies of substantiating
information.
. Make a note in the field book of
any records not maintained.
image:
B-8
Violation: Failure to Report All Required Information
Regulatory Requirements
Inspection Procedure
Documentation
Initial Inventory
§710.3(a)(1)
. Ask to see total sales figures for 1977
Any person who manufactured chemical
substances in 1977 must report:
1) All chemical substances at each site
for vrtiich 30% or more by weight fall into
SIC Group 28 or 2911.
2) All chemical substances at each site
where one million pounds or more were
manufactured.
3) Any chemical substance manufactured
at a site in quantities greater
than 100,000 lbs.
§710.3(a)(2)
Any person who imported chemical
substances in 1977 must report:
1) All chemical substances for which
30% or irore by weight fall into SIC
Croup 28 or 2911.
2) All chemical substances imported
as part of a total of one million
pounds.
3) Any chemical substance imported
in quantities greater than 100 000 lbs.
. Ask to see 1977 production records for
each suspect product.
. Make a copy of records.
If records are not avail-
able, make a notation in
the field book.
. Make a copy of the records
. If they are not available, make
a notation to this effect in the
field book.
image:
B-9
Violation: Failure to Report Ml Required Information
Regulation Requirements Inspection Procedure Documentation
§710.5
Manufacturers and importers required to
report must report:
1) the identity of the chemical substance,
2) those monomers used at greater than
2% (by weight) in the manufacture of a
polymer,
3) whether the substance is manufactured
or imported
Manufacturers must also report:
1) the site at vfoich the substance is
manufactured and whether the chemical
substance is manufactured only within
a site.
2) the amount of the chemical substance
manufactured at each site.
Importers must report the total amount
of ctiemical substance imported.
§710.5(a)(3)
Any small importer or manufacturer
(total annual sales of company, parent-
company, and all companies ownel or
controlled by the parent together are
less than $5 million) is exempt from
reporting production volume (for
quantities less than 100,000 pounds)
and site information.
image:
Appendix C-l
Inventory Reportinq Regulations
Reearanended Format
Establishment Inspection Checklist
Date
Name of Facility
Dun arri Bradstreet #
Location
Phone Nuntoer
Inspector
Persons Contacted:
Name
Title
Eftone Number
image:
C-2
Record Maintenance (1977)
Chemical Identity
Monomers used at greater
than 2% (by weight) in
the manufacture of a
polymer.
Chemical Substance is
Manufactured
Processed
Imported
Production
30% by weight in SIC Group 28 or 2911
Total
Per Chemical Substance
Sales
Total
Per Chemial Substance
Distribution
Use
internal (Site-limited)
External
Advertisements
Production Site(s)
Size
Number
Criteria for R&D Substances
Criteria for test marketing substances
Qualifications and responsibilities of the
person in charge of production & dis-
tribution of a chemical substance
'later revised inventory publication
image:
Appendix D-l
Citation Charges arrf Action Levels for Violations of the
Inventory Reporting Regulations Promulgated Under Section 8(a) of
the Toxic Substances Control Act
PERSON FAILED TO OOMPLY WITH THE PROVISIONS OF THE INVENTORY REPORTING REQUIREMENTS
PROMULGATED UNEER SECTION 8(a) OF THE TOXIC SUBSTANCES CONTROL ACT IN THAT THE 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. (42 FR §710.3(a)(1)(i)(a))
Action Level: Complaint and/or
Premanufacture Notification Requirement
A2. Failed to report concerning a chemical substance manufactured in the
U.S. for a canmercial purpose during 1977 as required because the total
pounds of reportable chemical substances manufactured at that site
equals one million pounds or more.
(42 FR §710.3(a)(1)(i)(B))
Action Level: Complaint and/or
Premanufacture Notification Requirement
A3. 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.
(42 FR §710.3(a)(1)(ii))
Action Level: Ccmplaint and/or
Premanufacture Notification Requirement
A4. Failed to report concerning a chemical substance imported into the u.S
for a ccmmerical 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)(1)(i)(A))
Action Level: Ccmplaint and/or
Premanufacture Notification Requirement
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 oound<? or
more. (42 FR §710.3(a) (2)(i) (B)) ^ r
Action Level: Ccmplaint and/or
Premanufacture Notification Requirement
image:
D-2
A6. Failed to report concerning a chemical substance imported into the
U.S. for a commercial purpose during 1977 as required because imported
in quantities equal to or greater than 100,000 pounds.
(42 FR §710.3(a)(2)(i)(B))
Action Level: Ccmplaint and/or
Premanufacture Notification Requirement
A7. Failed to report a chemical substance by the May 1, 1978 deadline
without an extension (42 FR §710.6(a))
Action Level: Notice of NOn-canpliance or
Ccmplaint and/or Premanufacture
Notification Requirement
AS. Failed to report the site at which he manufactured the chemical sub-
as required for all but small manufacturers. (42 FR §710.5(d) (2))
Action Level: Notice of Non-compliance or
Ccmplaint
A9. Failed to report the business address at which he imported the
chemical substance as required for all but small importers (42 FR
§710.5(d)(2))
Action Level: Notice of Non-compliance or
Ccmplaint
A10. Failed to report the amount of the chemical substance which he manufac-
tured at each site for vfaich reporting was required in 1977.
(42 FR §710.5(d)(4))
Action Level: Notice of Ndn-canpliance or
Ccmplaint
All. Failed to report the amount of the chemical substance which he imoori-pH
during 1977. (42 FR §710.5(d)4)).
Action Level: Notice of Non-compliance or
Ccmplaint
A12. Failed to report that manufacture of the chemical substance is site
(42 FR §710.5(d)(3) lce -Limited.
Action Level: Notice of NOn-compliance or
Ccmplaint
A13. Falsely reported the amount of the chemical substance manufactured
at any site during 1977. (42 FR §710.5(d)(4))
Action Level: Notice of Non-ccmpliance or
Ccmplaint
image:
D-3
A14. Falsely reported the amount of the chemical substance imported
during 1977. (42 FR §710.5(d)(4))
Action Level: Notice of Non-compliance or
Gcmplaint
A15. Reported a chemical substance excluded frcm the inventory because
manufactured solely in small quantities for research and develop-
ment. (42 FR §710.4(c) (3)).
Action Level: Notice of Non-canpliance or
Ccntplaint and/or
Premanu facture Notification Requirement
A16. Reported a chemical substance excluded from the inventory because
imported soley in small quantities for research and development.
(42 FR 5710.4(c)(3))
Action Level: Notice of Non-compliance or
Complaint and/or
premanufacture Notification Requirement
A17. Reported a chemical substance excluded from the inventory because
processed, solely in small quantities for research and develop- "
ment. (42 FR §710.4(c)(3))
Action Level: Notice of Non-canpliance or
Canplaint
A18. Reported a chemical substance excluded frcm the inventory
because not manufactured, for a commercial purpose January 1,
1975. (42 FR §710.4(c)(4))
Action Level: Notice of Non-ccmpliance or
Canplaint and/or
Premanufacture Notification Requirement
Al9. Reported a chemical substance excluded from the revised inventory
because not processed for a commercial purpose since January 1,
1975. (42 FR §710.4(c)(4))
Action Level: Notice of Non-compliance or
Canplaint
A20. Reported a chemical substance excluded frcm the inventory because
not imported for a commercial purpose since January 1, 1975
(42 FR §710.4(c)(4))
Action Level: Notice of Non-ccmpliance or
Ccntplaint and/or
Premanufacture Notification Requirement
image:
D-4
A21. Reported a chemical substance excluded from the inventory because
regulated under the Federal Insecticide, Fungicide and Rodenticide Act.
(42 FR 5710.4(c)(1))
Action Level: Notice of Non-ccrnpliance
A22. Reported a chemical substance excluded from the inventory because
regulated under the Federal Food, Drug and Cosmetic Act.
(42 FR §710.4(c)(1))
Action Level: Notice of Non-compliance
A23. Failed to maintain records that document information reported
under the regulations (42 FR §710.1(c))
Action Level: Notice of Non-canpliance or
Complaint
A24. After being presented with a warrant, failed to permit access to
records that document information reported under the regulations.
(42 FR §710.1(c))
Action Level: Complaint
A25. After being presented with a warrant, failed to allow EPA officials
to copy records that document information reported under the
regulations. (42 FR §710(c))
Action Level: Complaint
image:
E-2
Sales/distribution records indicate that less was produced than was
reported. There are no other records indicating on-site (non-
sales) use to complement the sales figures.
A14. Purchase records shew higher figures than those reported.
Purchase records show lewer figures than those reported.
Sales/distribution records shew higher figures than those reported.
Sales/distribution records show lewer figures than those reported.
A15. Evidence may vary frcm company to company. Generally a violation
can be supported if a company 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 considered together.
Before publication of the revised inventory:
. The substance is marufactured in quantities of less
than 1,000 pounds.
. The substance is gold but purchasers cannot corroborate
commercial use.
. The substance is not sold, and there is no record of
use in any process resulting in another commercial
product.
After publication of the revised inventory:
. The substance, whether or not sold, is used by or under
the direct supervision of a technically qualified individual
who is concerned with evaluating the physical chemical,
and performance characteristics of the substances.
A16. Evidence may vary from company to company. Generally a vio-
lation can be supported if a company is inconsistent in
formulating criteria defining an R&D substance for §8(b) and
55(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 imported in quantities of less than
1,000 pounds
. The importer has no records to substantiate that the
final user uses the substance for commercial purpose
or uses it in a process resulting in another commercial
product.
image:
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 super-
vision of a technically qualified individual who is....
concerned with evaluating the physical, chemical, and
performance characteristics of the substance.
A17. Evidence may vary from company to canpany. Generally a violation
can be supported if a cctnpany is inconsistent in formulating
criteria defining an R&D substance for §8(b) and §5(h).
The following factors, which alone would not be sufficient to
indicate a violation, may create a stronger presumption
when considered together:
Before publication of revised inventory:
. The substance is processed.in quantities of less
than 1,000 pounds.
. The substance is not sold, and there is no record of
use in any process resulting in another commercial
product.
After publication of revised inventory:
. The substance, whether or not sold, is used by or under
the direct supervision of a technically qualified
individual who is concerned with evaluating the physical,
chemical, and performance characteristics of the substance.
A18. other data sources show the substance has not been manufactured
since January 1, 1975.
Canpany production records show no evidence of manufacture
since January 1, 1975.
Company sales/distribution records show no evidence of sales
since January 1, 1975.
Reputed buyers fail to corroborate purchase.
Company records show no evidence of internal use.
A19. Other data sources show the substance has not been processed since
January 1, 1975.
Company production records show no evidence of processing since
January 1. 1975.
Company sales/distribution records show no evidence of
sales since January 1, 1975.
Reported buyers fail to corroborate purchase.
image:
E-4
Company records shew no evidence of internal use.
A20. Other data sources show the substance was not imported
since January 1, 1975.
Canpany production records show no evidence of importing
since January 1, 1975.
Ccmpany sales/distribution records show no evidence o£
sales since January 1, 1975.
Reputed buyers fail to corroborate purchase.
Canpany records show no evidence of internal use.
A21. Substance has a use regulated under FT ERA and there is no
evidence of another current use for the substance in advertise-
ments sales/distribution or other ccmpany records.
A22. Substance has a use regulated under FFDCA and there is no
evidence of another current use for the substance in advertise-
ments sales/distribution or other canpany records.
A23. No records are available to substantiate claims upon routine
inspection. Affidavit from inspector attests to this fact.
A24. Affidavit frcm inspector 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 from inspector attests to the refusal by the person
to allow him to copy records upon presentation of a search
warrant.
image:
APPENDIX F—1
GRAVITY BASE PENALTY MATRIX
1 | | Extent of Damage |
1 1
I
MAJOR
I MINOR I
1 1
1 Potential that I
1
High 1
25/000
1 |
I 5,000 j
1 Damage will I
Range I
20,000
I 3,000 |
1Occur !
1
1 |
1 I
LCW I
5,000
I 500 |
1 1
Range 1
2,000
1 250 |
image:
Appendix G-I
Guidance for Computation of Civil Penalties Using the
TSCA Civil Penalty Assessment Worksheet
Scope
The TSCA Civil Penalty Assessment Worksheet is to be used to compute
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
modifications or adjustments of the proposed penalty. The Worksheet
also serves as an office record of the case and as a memorandum of the
Agency's deliberations concerning the penalties proposed and finally
assessed for the violations cited.
Gravity Base Penalty
(1) List the "Charge Code Number" as indicated under column headed
"Charge Code". Such charge code numbers must conform to the charge as
written in the ccnrplaint.
(2) List each "primary" charge in the same order as it appears in
the ccmplaint. A charge which represents an independent act (or failure
to act) and which is substantially distinguishable from 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 ccmplaint but which does not arise from independent acts and
which is^ot substantially distinguishable frcm another previou^y
cited charge). TSto independent penalty shall be assessed for sudi a
charge.
(4) The "penalty base figure", 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 adjustment
is in order, consult the "Table of Adjustment Factors - History" and
the accanpanyirg guidance to determine the approbate adjustment
factor. Enter the percentage increase on the worksheet.
(6) Review information relating to culpability of the violator.
If an adjustment is in order, consult the guidelines to determine the
adjustment factor. Enter the adjustment factor (20% or 40%) on the
worksheet.
image:
G-2
(7) Review sales data and culpability level to determine if an
adjustment to account for Ability to Pay is appropriate (Ability to Pay
adjustments are only made when there is a level 2 or 3 culpability).
Consult the guidelines to determine the adjustment factor and enter
the percentage decrease on the worksheet.
(8) Total the percentages entered under Items (5), (6) and (7)
and adjust the GBP in Item (4) by this percentage. Enter the resulting
modified GBP on the worksheet.
(9) Enter the explanation for modification 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 modification, the
proposed penalty will be the same as the base figure under Item (4).
For any primary charge for which the base figure has been increased
or decreased, the "modified 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 Item (10).
(12) If at the settlement conference, respondent makes and sub-
stantiates additional representations concerning history of violation,
culpability, inability to pay or remain in business or "such other
natters as justice may require" which the Agency could consider in
mitigating the proposed penalty, enter a summary 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 compulsion to mitigate the proposed penalty.
(13) If reduction is deemed appropriate for the penalty proposed
for a given charge, enter the percentage by which the proposed penalty
should be further decreased.
(14) Compute the "negotiated penalty amount" for each primary
charge based on the percentage reduction (indicated in Item (13)) of
the penalty proposed for that charge (indicated in Item (10)), and
enter the amount.
(15) Enter the "final civil penatly amount" for each primary
charge. Where there has been no negotiation or reduction, the final
penalty will be the same as the proposed penalty for that charge under
Item (10). Where there has been a reduction from the proposed penalty,
the "negotiated penalty amount" under I tan (14) shall be the final
penalty amount.
image:
G-3
(16) If the respondent introduces na* facts at the settlement con-
ference which bear on the gravity of the violation and which may modify
the original charges, enter the date of the conference, a summary of the
new facts, and a summary of the substantiation. Then begin a new Work-
sheet to reflect the modified charges and a new proposed penalty.
Total Final Civil Penalty Assessed
(17) Enter the "total final civil penalty assessed" as a result of
the following: (a) Default (number 4 in the heading of the Worksheet);
(b) consent agreement (number 5 in the heading of the Worksheet) after
a settlement conference;
(18) Enter the "total final civil penalty imposed" as a result of
the Final Order of the Regional Administrator.
image:
Appendix H
CIVIL PPW .TV ASSESSMENT HHlKSItKET
iUDi of |«St>»knt
KUksi of KL-s(ionJent_
1. GonpUlnt I.D. >to.
2. Data Cnplalnt Issued
3. Data Answer Hec'd
4. Date Default C*Jer fient_
5. Date Consent Agreement
Signed
i. Dabs final icilec Scut
7. Ditt Rtaltbinui iuc'd '
TTi (2l
Charge ft uvtry
Cute Ovirge(s)
Nucwer
Cravity Haw WMlty
^141
GI1P
(I'huxiit in
matrix cell)
{51
History
Percentage
Increase
Adjustments
Culpability
Mrcentage
Itecrea&e
m
Inability to
Fay Percentage
Decrease
ftOpOSt*!
<hT~~
Mulifi*) («!•
($ reflecting
Increase or
docrease if
applied)
Adjusted penalty
—noi un —*—
Froiused Kccantagt (!)
Kiulty Decrease
(total toe history,
culpability.
Inability to pay,
other (utters am
Justice aay
require
fHl
Negotiated
Penalty Mount
It reflecting %
decrease if
applied)
final pena
7I5T
Final
Civil
Penalty
taont
T51
Ussser Included Charged
prepared by_
li| Vital Proposed Penalty J_
Concurrence by_
17) Dotal final Civil tensity Assessed f_
111 lotal final Civil penalty |if«tal J_
image:
WORKSHEET {»f»«tse SH«)
Deriving the Modified Penalty 2ase Figure
<91 "Modification ot the Penalty Ba3e Figure (under line(8)
Oats of Modification
Reasons Sot Modification
Date of Conference
(12) Additional Representations
History ____________
Substantiation
Culpability
Substantiation.
Inability to Pay/ Continue in Business
Financial Data Offered by Respondent (Source and Summary)
Other matters as justice may «qui»_
Substantiation^
(16) New Gravity Determination
New Facts
Prepared Sy_
image:
APPENDIX I
FEDERAL REGISTER PUBLICATIONS
March 9, 1977
April 12f 1977
April 28, 1977
July 8, 1977
August 2, 1977
October 3, 1977
Deceirfcer 23, 1977
March 6, 1978
April 17, 1978
October 24, 1978
Original Proposal of Inventory Reporting
Regulations (42 PR 12120)
Supplemental notice of proposed rulemaking,
including additional information pertaining
to proposed regulations , and instructions
for use of the Candidate List of Chemical
Substances (42 FR 19298)
Notice of availability of the Candidate List
of Chemical Substances for use in reporting
Chemicals for inclusion in the inventory.
(42 FR 21639)
Notice to amend procedures for securing a
copy of the Candidate List on computer-readable
tape (42 FR 35183)
Pe-proposal of Inventory Reporting
Regulations (42 FR 39182)
Supplemental notice (42 FR 53804)
Final Inventory Reporting Regulations
(42 FR 64572)
Supplemental Clarification and Notice of
Meetings (43 FR 9254)
Supplemental Clarification and Availability
(43 FR 16178)
Policy for Revised Inventory Reporting
arri Draft Report Form (43 FR 49688)
image:
APPENDIX J-l
Statutory Authority for the Inventory Reporting Regulations and
Enforcement Program
—Section 8(a)(1)(A) authorizes the Administrator to require, by rule, the
maintenance of records and submission of reports regarding production by-
products, population exposure, etc cf a chemical substance.
—Section 8(b) directs the Administrator to ..compile, keep current,
and publish a list of each chemical substance which is manufactured or
processed in the United States... Such list may not include any chemical
substance which was not manufactured or processed in the United States
within three years before the effective date of the rules promulgated
pursuant to [the inventory[
...The Administrator shall not include in such list any chemical sub-
stance which is manufactured or processed only in small quantities (as
defined by the Administrator by rule) solely for purposes of scientific
experimentation or analysis or chemical research on, or analysis of, such
substance or another substance, including such research or analysis for
the development of a product."
—Section 11(a) authorizes any duly designated representative of the
Administrator to "...inspect any establishment, facility or other premises
in which chemical substances or mixtures are manufactured, processed,
stored, or held before or after their distribution in ccmmerce...Such
an inspection may only be made upon the presentation of appropriate cre-
dentials arri of a written notice to the owner, operator, or agent in charge
of the premises...to be inspected. A separate notice shall be given for
each such inspection, but a notice shall not be required for each entry
made durirq the period covered by the inspection. Each such inspection
shall be commenced and completed with reasonable promptness 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 promises or conveyance inspected (including records, files, papers,
processes, controls, and facilities) bearing on whether the requirements
of this Act applicable to the chemical substances or mixtures within such
premises or conveyance have been complied with.
—Inspections are prohibited, under Section 11(b)(2), which extend to:
"(A) financial data, (3) sales data (other than shipment data), (C) pricing
data, (D) personnel data, or (E) research data (other than data required
by this Act or under a rule promulgated thereunder), unless the nature
and extent of such data are described with reasonable specificity in the
written notice required by [Section 11(a)].
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APPENDIX J-2
—Section 11(c) authorizes the Administrator to require by subpoena
"...the attendance and testimony of witnesses and the production of
reports, papers, documents, answers to questions, and other information
that the Administrator deems necessary" for carrying out this Act.
—Section 15(1) makes it "...unlawful for any person to fail or refuse
to comply with...any requirement under Section 5 ...or any rule promul-
gated or order issued under Section 5."
—Section 15(2) makes it "...unlawful for any person to use for commer-
cial purposes a chemical substance or mixture which such person knew
or had reason to know was manufactured, processed, or distributed in
commerce in violation of Section 5... a rule or order under Section 5...
or an order issued in action brought under Section 5...."
—Section 15(3) makes it "...unlawful for any person to fail or refuse
to (A) establish ard maintain records, (B) submit reports, notices, or
other information, or (C) permit access to or copying of records, as
required by this Act or a rule thereunder."
—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)(1) provides for the? assessment of civil penalties not
to exceed $25,000 for each violation of Section 15.
—Section 16(b) provides for criminal penalties of fines of not more than
$25,000 for each day of violation, or imprisonment for not more than one
year, or both, for 5<nowir*3 or willful violations of Section 15.
—Section 17(a) gives jurisdiction to the district ccurts of the United
States to provide specific enforcement regarding the provisions of
Section 15, or to canpell 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 manufactured, processed, or distributed in commerce
in violation of this Act or any rule promulgated or order issued under
this Act.
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•"* - 1
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
UUN 2 3 1980
OFFICE OF ENFORCEMENT
MEMORANDUM
SUBJECT: Inventory Penalty Policy
TO: 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.
Deputy Assistant Administrator
for General Enforcement
Attachment
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Inventory Penalty Policy
It. Introduction
This section of the TSCA Penalty Policy describes the application
of i£he policy to violations of the Inventory reporting regulations.
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 violations.
5) Application of. the Gravity Based Penalty.
-6) The use of adjustment factors.
7) Relationship to §5 penalties.
II. Violation Determination
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.
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A notice of non-compliance will be the most appropriate action
if the following circumstances exist:
1) It cannot be held that the alleged violator "knew or should
have known" about the Inventory reporting regulations.
Circumstances 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 identification, 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 deadl*
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
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reported on time.]
2) A firm learned of 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.]
h civil penalty will be the most appropriate action in cases where
circumstances indicate that a firm "knew or shouid have known" of the
procedural or substantive requirements of the regulations 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 yst 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 m 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 associations.
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.
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• 4 -
IV. independently Assessable Charge
If a civil penalty is the appropriate t^es of enforcement
action for identified violations, the enforcement attorney/case
preparation officer mast still determine whether a civil penalty
should be assessed for each identified violation. A separate
. r- /-iniv for each violation of the
civil penalty shall be assessed only tor eacn
which results from an independent
Inventory reporting regulations whicn r
*.\ r\f the respondent and which is substantially
act (or failure to act) of the respoi
„.har rharae in the complaint. A given
distinguishable from any other charge
j «MH«tantiallv distinguishable from any
charge is independent and substantias
s»csessinq separate penalties if each charge
charge for the purpose of assessing r»
* recuired by the other. Thus, not
requires an element of proof not require *
< in the complaint will be separately
fcevery charge, which may appear
# , manufacturer may fail to report at all
assessed. For example, a manufacturer my *~
u -„»i mhatance for which reporting is required,
concerning a chemical sudstan
He could be charged separately for failing to report each ite» of
information required by the regulations. However, since the charge
at- all contains the same elements required to
for failure to report at all concan »
prove a failure to report individual items of information, a civil
penalty should be assessed only for the failure to report at all.
V. Multi-day Violations
TSCA §16 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 computed
from the appropriate deadline for compliance. Such an approach, however,
would result in excessive penalties. Therefore, for purposes of
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computing the civil penalty for an Inventory reporting violation, there
will be only one day of violation, the day on which the violation is
discovered by EPA. No inventory violation will be considered a
continuing violation.
VI. Calculation of the Gravity Based Penalty
The Inventory Reporting 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
.... r« nt from the "damage" which determines
assessment" violations Ls different irom
and "control associated data gathering"
the GBP for "chemical control ana conuui ^
. , „ former case is to the abilityof the
violations. The damage xn the former case j
¦Agency to carry out its regulatory functions, while in the latter two
cases, the damage is to health or the environment. As a result, the
GBP for -hazard assessment- violations is based on consideration of
qualitative factors rather than of quantitative factors such as pounds
of the chemical involved as is the case with the GBP for -chemical
control- and -control-associated data gatherinj" violations.)
The GBP 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 insignificant.
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 GBP
matrix follows.
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EXTENT CF POTENTIAL DAMAGE
MAJOR
i 1
I SIGNIFICANT I
MINOR |
Level A
I Level B I
Level C 1
1 1
*»
1 1
1
1 HIGH RANGE I
i
25,000
! !
1
1 f
2
1 1
1
1 MID RflJGE i
3 1
15,000
1 f
I
i r
4 1
1 I
1,000 I
I LCW RANGE I
5 1
5,000
1 1
500 I
i r
6 1
I 1
200 1
A. Extent
The "extent" of damage caused by an Inventory reporting violation
is measured by__the potential impact of the violation on the Agency' e
ability to implement and enforce TSCA. The GBP matrix for the
Inventory reporting regulations provides two levels for measuring
<0fent:
t»evel A (Major) - Potential impairment of the Agency's ability to
properly implement and enforce §5 PMN requirements
for a given substance.
Level C (Minor)- Potential impairment of the Agency's ability to
rely on the Inventory 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.
CirCUtltS tSHCeS /, £$- K'irrn U c~t £ c viu. t
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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Level 1 The violation causes the unnecessary submission of a
PMN by a third party, and the Agency has unnecessarii
spent the resources required for a complete premanu-
facture review.
d Ranqe - The violation causes the unnecessary submission of a
PMN by a third party, and the Agency has unnecessarii
*Spent resources in beginning premanufacture review.
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.
The violation has unnecessarily caused the Agency to
receive premanufacture notification forms for a given
chemical.
The violation could have resulted in subversion of
the^PMN requirement if the substance had been
included on the Inventory.
The violation results in impairment of the Agency's
Inventory data base with respect to less than tha
total number of information items required to be
reported concerning a chemical substance.
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
had been included in the data base.
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 Violation^
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 npondH
Level 1 implement S5 in that it could resuk in Y
avoidance of timely premanufacture notifies
because the substance was include on fch* tlor
Inventory. ¦—
Level 3
Level 4
Low Range
Level 5
Level 5
Level 5
Level 6
Level 6
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- 8 -
$5,000 Major
Low The substance reported is ineligible for
Level 5 inclusion on the Inventory. Although the
substance was not included on the Inventory,
the Agency had to expend substantial resourc
to prevent subversion of the §5 PMN require-
ment.
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, (late* report).
[Note: A violation will be found and will be
assessed for each inaccurately reported item
Citation Charge Codes A8-12
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 oron®^
Level 1 implement §5 in that it may result in ne*S
less PMN by a third party.
Minor
$1,000 Mid If the substance was reported bv someone
Level 4 else, the violation affects the*Agency's
ability to use the Inventory data as a
basis for hazard assessment and complianc
monitoring. e
Citation Charge Codes Al-6
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o Failure to Report on Time
Persons whose late reporting has resulted in
the commencement of PMN activity will be
assessed a penalty '-nder the Major extent
category. The penalty level assessed will
depend on the stage of the PMN review process
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 adjustment factors discussed in the TSCA Penalty Policy pages
9-17 can be applied to Inventory violations without further modification.
fall. Relationship to Penalties under §5 TSCA
It should be noted that certain Inventory reporting violations may
result in violation of the §5 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 §5 requirements.
Major
$25,000 High
Level 1
15,000 Mid
Level 3
5,000 Lovf •
Level 5
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Appendix A
Sample Citation Charges and Action Levels for Violations of the
Inventory Reporting Regulations Promulgated Under Section 8\a) of
the Toxic Substances Control Act
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE INVENTORY REPORTING
REQUIREMENTS PROMULGATED UNDER SECTION 8(a) OF THE TOXIC SUBSTANCES
CONTROL ACT IN THAT THE 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 §710.3{a)(1){i)(A)}
Action Level: complaint and/or > t
premanufacture Notification Requirement*
A2. Failed to reDort 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 §710.3(a)(1)(i)(B)
Action Level; complaint and/or ,
Premanufacture Notification Requirement*
b. 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 §710.3v3>)\1) ( )
Action Level: Complaint and/or .
premanufacture Notification Requirement*
A4. Failed to report concerning a chemical substance imported into the
U.S. for a commercial purpose because 3 0% or more of the products
imported are described by Standard industrial Classification (SIC)
Group 28 or 2911. (40 CFR §710.3\a)\2)\1)ii)\A))
Action Level: Complaint and/or
premanufacture Notification Requirement*
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 §710.3\a)\2)ii)\B))
Action Level: Complaint and/or
premanufacture Notification Requirement*
|A complaint alone will be appropriate in cases where another person has
^ported concerning the chemical substance. PMN should be required
in 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 §710.3 \a)\2)\i)\B))
Action Level: Complaint and/or
Premanufacture Notification Requirement*
A7. Failed to report a chemical substance by the July 1, 1979 dead-
line. {40 CFR §710.6{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"!^? all but small manufacturers.
(40 CFR §710.5{d){2))
Actipn 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 §710.5{d){2))
Action Level: Notice of Non-compliance or
(Complaint
A10. Falsely reported the amount of the chemical substance which
he manufactured at each site for which reporting was
required in 1977. {40 CFR §710.5\d)\4))
Action Level: Notice of Non-compliance or
Complaint
All. Falselv reoorted the amount of the chemical suoscance which he
imported during 1977. {40 CFR §710.5{d){4))
Action Level: Notice of Non-compliance or
Complaint
Al2. Falsely reported that manufacture of the chemical substance is
site limited. {40 CFR 5710.5(d)t3))
Action Level: Notice of Non-compliance or
Complaint
* See Appendix A-l
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A-3.
A13. Reported a chemical substance excluded from the Inventory
because regulated under the Federal Insecticide, Fungicide
and Rodenticide Act. (40 CFR §710.4(c)(1))
Action Level: Notice of Non-compliance
Complaint and/or
premanufacture Notification Requirement**
A14. Reported a chemical substance excluded from the inventory
because regulated under the Federal Food, Drug and
Cosmetic Act. (40 CFR §710.4(c)(1))
Action Level: Notice of Non-compliance
Complaint and/or
Premanufacture Notification Requirement**
A15. Reported a chemical substance excluded from the inventory
because manufactured solely in small quantities for
research and development. {40 CFR §710.4(c)(3))
Action Level: Notice of Non-compliance or
Complaint and/or
Premanufacture Notification Requirement**
A16. Reported a chemical substance excluded from the inventory
because imported solely in small quantities for the
research and development. (40 CFR §710.4(c)(3))
Action Level: Notice of Non-compliance or
j;Complaint and/or
:iPremanufacture Notification Requirement**
*
A17.Reported a chemical substance excluded from the inventory
because processed solely in small quantities for research
and development. (40 CFR §710.4(c)3))
Action Level: Notice of Non-compliance or
Complaint
Al8. 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 Requirement**
**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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A-4
A19. Reported a chemical substance excluded from the Inventory
because it is an impurity. (40 CFR §710.4(d)(1))
Action Level: Notice of Non-compliance or
Complaint and/or
Premanufacture Notification Requirement**
A20. Reported a chemical substance excluded from the Inventory
because it is a byproduct with no commercial purpose. (40 CFR
S710.4{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))
-Action Level: Notice of Non-compliance or
Complaint
**See A-3
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£\ \
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. O.C 20460
July 22, 19S2
MEMORANDUM
SUBJECT: Compliance Strategy for the Preliminary Assessment
Information Reporting Kule (Level A Rule)
The final version of the Level A Rule was published in
the Federal Reqister on June 22, 1982 (47 Federal Register
26992). Attached is" the Compliance Strategy for this
role. A proposed strategy was circulated in July, 1980, for
comment. This document reflects comments on the proposed
strategy and changes to the proposed rule.
If you have any questions please contact Pamela Harris
(FT S 755-9404) of my staff.
TO:
Air and Hazardous Materials Division Directors
Environmental Services Division Directors
Toxic Substances Branch Chiefs
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 kor the preliminary assessments
INFORMATION REPORTING RULE (Level A Rule)..
Overview 1
Requirements of the Regulation 1
Who Must Report
L1 s ted Chernlc al s
Exempti ons
What to Report
Reporting Period
When to Report
Where to Report
Compliance Assistance 5
Regulated Industries 5
Compliance Background .6
Obj ecti ves
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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, 1 : no- jtratogy t*H' I'rel iminary Assessment I ntorra tion Reporting
Rule Under 7 3 C A § 8 ( a ) - (Level A Reporting Pule)
C v e r v i e w
The Environmental Protection Agency (EPA) publ1 shed the Preliminary
Assessment Information Reporting Rule on June 22, 1982 ,
authority of Section 8fa) of the Toxic Substances Control Act
(47 Federal Register 2o9->Z). Manufacturers including importers ra«st
subrnT~t i 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 pri
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 §8 Reporting Rules.
The Preliminary Assessment Information Reporting Rule anticipates two
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
recrooosed ™ ll Fed Reg. 27009 . dated Oune 22 ,1982 . Processors,
will be asked to report only if the Agency does not obtain sufficient
information about the chemicals from the manufacturers.
The Pesticides and Toxic Substances Enforcement Division (PTSEO) will
concentrate its major compliance monitoring efforts on the detection
of th« following violations: (U 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 reaulation of a dangerous chemical. The enforcement activities
will also assist OTS in assessing overall validity of the information
submitted.
Requirements of tne Regulation __ _
Who Must Report
have to report are those who produce or import any
Manufacturers who have unces or wh0 apply any method of extraction.
of the listed chemic mined substance to make it marketable
refinement or purificat o undefined or variable concentra-
??o^iU"JeTorrnUerroCre™ariet<n9 as a listed chemi=a, <s not
subject to this rule.)
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Importers should report chemical substances imported in bulk in any
qrade 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 inc1ude.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 §712.30. (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 u"<jer the specific
Isomer CAS number if they were producing an isomer alone. They
should rpnort a chemical under the more general CAS number if they
Ire a SlSre .f Isomers. T»n Is the same policy used
for Inventory reporting.
Exempti ons
A smell business exemption applies 1f 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 $30,000,000.
A small ouanti ty exemption applies if,a site manufactures less than
S00 ki 1 ograms (1 ,1 <><¦' pounds) of the chemical.
Other exemntfons are for fmporters of mixtures and articles, manufac-
s c develops t chemicals (1) and manufacturers
sole y produce ?he chemical as an impurity or . byproduct or a
nonisolated intermediate. There are n£ exemptions for test marketing
< *>\
(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 1n commerce of a
limited amount of a chemical substance or mixture or article con-
taining 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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- J -
What to Report
The Information required by this rule must be reported on the
Preliminary Assessment Information Reporting form. (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 "readily ascertainable Information. This
is the most accurate Information easily available to the submitter.
The data reporting section of the form (Section IV on P«J9e 2) has
two parts: Part A: Plant Site Activities and Part B: Chemical
Substance Processing. Production, processing and use at each single
domestic manufacturing site must be reported on Part A. 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 general population from the chemical.
Part A
0 Items 1 and 2 - Total quantities of chemical imported
and domestically produced.
# Item 3 - Quantities of chemical lost
- Item 3(a) Indicates .quantities 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 1n wastes not treated to
destroy the chemical
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° Items 4, 5, 6, and 7 - Quantities of chemical, worker
hours and number of workers 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.
0 Item 8 - Quantity of chemical the manufacturer makes into
products to be used by industry or in consumer products,
i ncludes:
- The chemical itself and mixtures containing the chemical.
- Articles with some release of the chemical possible.
- Articles with no release.
Part B
0 Item 9 - Quantity of chemical the customer malces 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 manufactured 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
1n §712.30. (The company reports the period covered by its report
on page 1 in the upper right corner.) If the Company did not
manufacture a chemical during that year, it does not report for 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 resubmission from OTS for good cause. (The Assessment
Division will 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 Toxic Substances
Environmental Protection Agency
P. 0. Box 2080
Rockville, Maryland 20852
Compliance Assistance"
I AO
Information about the rule has been published in various trade
« «ose published by the Chemical Manufacturers
Association, Chemical and Engineering News and J^ers, so that
the chemical industries subject to the rule * maoi will send
about its content. The Industry c®. ^ i,nowr,
rnnipc of thp Federal Register notice and the form to all known
ma'nlflc^rers STWsiffen^ I frf e'sln ?h%
the inventory). Members of CMA will not receive Packages In the
initial mailing. Under an agreement between CMA and IAO, CMA
members will call IAO and specify the number of forms na"*n
the contact to whnm IAO should mail the forms. IAO will then mail
the mt ° o' h mo 1 • (This procedure has been adopted because
tfhe mailinq 1i st 1s set up to mail forms to plant sites whereas most
men.be?? Jm lan?"hePforms »«ile\"h";p?"J?dhef!drS"rt?":' .
ShJ'do'nSt' 0? rn'fnuJl? 0a?™ngS -ay
ohtain lh«m hv ralllno the IAO (800-454-9065) which 1s the source of
a 1 orms Personswhonee^assistance U filling out the.forms may
!L mii'thI k!!h -<11 direct their question to someone in the Agency
also call IAO which will direct ine « ,, , addition.
who can «"'St « ' 'y.!' J},!!, ,iI,»ierst«nil«|S of the
instructTon willdeceive a chance to correct them. OTS will return the
form to the submitter with a letter explaining the
'fo^rkflJe^eTanT. d«dli»e for resub,ss1on Submitters who
desire further advice on resubmissions may call IAO.
Regulated Industries—11
^ruiarure;Lr45ue"t0edcr;"e,!p"rp^:u,fborra;?<,uir?stanrtts?;:ted
that 330™ompan1es Will report on "l4"" .J" ' 'otal
of 1300 reports. Processors may be asked to report at a later date.
IAO will cudoIv PTSEO with a 11st of companies which may be subject to
the rule ba?ed on the Inventory and the updated IOA mailing list of the
reporting forms.
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rbmpliance Sc.cTground
Objectives , ^ „ ,,
The objective of the compliance strategy is to ensure that all
required Information is reported in a timely and accurate fashion.
Types of Violation
There are four types of violations under TSCA §15(3)18):
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 falsified form does not satisfy the ^ c f "to \ °I
this rule under TSCA §8(a). and 1s a violation of TSCA §15{3){B) 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 ab lity to make
decisions concerning a chemical's effects on health and environ-
ment. Failure to submit the reports required by this rule 1s a
violation of TSCA §15(3)(B).
Failure to o«rnrt r.nmpletely or Consistently: Incomplete or
inconsistent reports also impair the Agency s ability to ake
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 OTS
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 Reoort 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 1s necessary under TSCA
and 1f so what form it should take. Late reports unnecessarily
delay the regulatory process. Reports which arrive later than 30
days after the deadline for submittal, resubmittal or extension will
be referred to PTSED for enforcement response. (OTS will process
reports which are less than 30 days late in the normal manner.)
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L i'incnTa^cc^bni tor i ng „
Von.pl iance «onf toeing for this rule will be P* r<-° J^d 1 n three
phases. These phases are Reports Processing and Verification
Neutral Administrative Inspections, and Response to Jips-and Com-
„ 1 , n», aii tines, during all three phases all Information
rljorUd or CO Uc eo from companies -111 be treated as Confidential
Business Information (CBIi following TSCA CB! procedures
otherwise specifically cleared through 5 P since
depends to some extent upon cooperation between IPTSED and °T5. Since
OTS is familiar with the regulated community, it will play a significant
role in violation detection.
Phase I: Reports Processing and Verification
Phase I of the compliance monitoring scheme ^intended to detect
incomplete or inconsistent reports and late ep • . . reports
tions will be detected 1n the course of routine Pressing of reports
by the Informatics General Corporation, ^ Reoorts which
Review of forms will Indicate 1 ncomplejc reports. ««P°^ which
contain certain tvoes of inconsistent Information will also be
detected as oart of the routine processing. Late reports are those
received \igSificantly later (30 days) than the required deadline.
Many inconsistent and incomplete forms J** °I.
misunderstanding of the reporting requirements and procedures.
?; n s >r r r"
response ir%Cru"nirs!'oTSWinib"f""n«™Ple« °r Inconsistent
rAiv£iii\i ;rsiDijo,r,UpTru«>.iiBfJ45!r.,t#tr.:j:i:s!rti;,e...n.
violations to PTSED for app P company in violation will accompany
the1r"ferral 'oTs'Sill also certify, as appropriate, that the Agency
did no treceivethere ports within:SO days •' Jh. .1
deadline or that the reports do not satisfy the requirements of the
rul e.
Since these violations are usually self-evident, "'11 generally
be "nHrmld\° the course of OTS """J"'"" Trooram
no insDections will be necessary for this phase of the program.
If?!,-?*™ artivities by OTS in this phase are a conse-
olation detect nrocessing of the forms by Informatics. Details
of6the OTS p«cess1"9 procedures are available from the Information
Control Branch (ICS) of OTS.
Phase II: Mitral 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 verification inspections.
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VtTi ficjtioi insPect,ons,^luebfpjareceivesrtheareporting forms,
-KMch submitted forrs. As the E ntrol niJT,ber for each form will
V data along with the document control number rore tfl
} put into the computer. The computer s,tes. a
production and geographical \ inspected using two
computer program will select tne
cri teri a:
• SUe - one fourth of the sUes j.l.etjj for
Vrll&ill SM i". 1. th. secono fourth
and so forth.
° Geographical dJst^butl°? the^t-cen^of °the total forms
in any state should equal the percent «
received which came from that state.
, .-.J., will be random. The computer
Within these two parameters cJi1verse that consists of all sites
program will consider an initial universe
which reported.
A few, about 5-10%t of the veJi ! ste^o^the Inventory as
companies which did not report out ar®. insoectlons will be targeted
manufacturers of a listed chemical. . f Headquaters. The -CMB
by the Compliance Monitoring Branch lu received forms or are on the
will obtain from I AO a list of s i tesw . -ca-js# Together with OTS,
Inventory as manufacturers of Level « c ^ return forms.
--^B will determine which sites on the business, or have already been
^mpanies which are clearly ncr °!?^erin se deleted from the list of
identified as violators of the rule wi targeted so that the percent
non-reporters. These inspections win . 1s equal to the percent of
of the inspections performed in ?acn y Otherwise the selection
companies on the list which are in
will be random.
j-j t0 pxsEO's Compliance Monitoring
Inspection reports will be fonjf}r°Jr r0mDared with Information received
Branch (CMB). These reports will oe £.de the information obtained
by OTS. OTS and PTSED PerSon?eI the information reported to the
during the inspection con^!5n w*11 refer the case to the Region for
Agency. If it is not, then PTSED
appropriate action.
, * *a differences between data reported and the
Significant, unexplained the Agency will take enforce-
data in the file represent a violation.
ment action.
Phase III: Response to Tips and Complaints
to EPA by complaints from competitors,
Some violations may be reP°r;®^ Referrals from the various divisions
former employes or other sou^nfQrmation about possible violations,
of OTS are another s°ur"f°£wirded to PTSED for Investigation. The
These complaints wflJ* *n depena on the nature of the «ltege<(
nature of the li investigation 1s to determine If
Isolation. The first .. rui« and if a report has been
7-he manufacturer is subject to the rule ana p
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-9-
recetved by OTS. The case wi11 then be referred back to the Regions
for an on site Inspection, if appropriate. The Agency will investigate
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 (CMS)
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 5 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 1s 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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"hilt; the rule has no recordkeeping requirements, relevant records
are likely to be kept for tax 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
and 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.
7FJMIUI STRATI VE CONSIDERATIONS
Program Management
DTccn .n/1 dts have developed report processing procedures that will
PTSED and 0T5 nave oeve uh faiiure to report, failure to report
dete5lt!?vPInd consistently, and late reporting. PTSED and OTS will
also target Inspections under the NAIS described in this document.
The Regions will conduct the inspections.
With OTS 1s iraoortant. The results of Inspections will
give oil an estate of the overall reliability of the
data reported under this rule.
Assistance from OTS 1s 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
i^formation" be used to complete the form, there are plausible
Ionizations for some minor inconsistencies between data already on
file with EPA and data discovered 1n the course of an inspection
consultation with OTS will be necessary in most cases, so that only
significant inconsistencies are the subject of enforcement actions.
*<nc that indicate a possible violation will be investigated first
Iffurther Investigation 1s indicated, the case will
il rlf.lr.t toiheRegion. A result of all inspections will be sent
thl Compliance Monitoring Branch (CMB). CMB will collaborate with
OTS M determine if a "olation has occurred. Any violations detected
SI H^adouarters or the Regions will be referred to the appropriate
Region for enforcement response, with concurrence from Headquarters.
Allocation of Kesponsibility
PTSED
o Policy and Stategy Guidance
o Liaison between Regions and OTS
o Violation determination (with OTS)
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.11.
fc 0 T S
o Processing of reports (detection and certi>ication of reporting
violations)
o Targeting NAIS 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 Oevelop cases and litigation with Headquarters concurrence.
Program Integration
t * ^ . , . „ Rule may be useful to working
Information received under this kui« 7 f#r % jf,c
groups which are developing "9fh^e°9roups .111 be In conformance
chetnlcals. Release of ^"confidential Business Information,
with TSCA procedures for handling uum
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appendix: Definitions of Terms
Byproduct: Any chemical substance or fixture produced
without a separate commercial intent during the manufacture,
processing, use, or disposal of another chemical substance
or mi xture.
Chemicals from natural sources: Chemical substances which
are extracted from an ore, from oil, or from any otner
natural source.
Impurity: A chemical substance unintentionally present with
anotner chemical substance or mixture.
Intermediate- Anv chemical substance that 1s consumed, in
whole or in part, in chemical reactions used for the intentional
manufacture of other chemical !u,>sJ"c"roJse'of "altering
that is intentionally present for the purpose of altering
the rates of such chemical reactions.
Anv intermediate that is not inten-
?? ated intermediate.;. ^» f , manufactured.
donally removed from «' J„ u is manufactured, equip.
nen^whUh is ancillary"" the reaction vessel, and any equipment
through Shich ?he Usance passes during a "»«»"««''««aJ"cess
but not including tanks or other vessels in which the substance
is stored after its manufacture.
Reactant: A substance which enters into and is altered by
a chemical reaction.
Process categories:
Enclosed Process - The process is designed and operated so that
there is not intentional inadvertent releases occur
process category, on y g t0 prevent worker exposure and
ana special measure ti _ "Special measures" refer to pro-
envi ronmenta1 contamin«11 on. mJnitored an<j used t0 prevent
cedures and rubbers and other recovery equipment
worker exposure, and . mentdj release, Equipment with
employed to Prevent ing wouid be allowed in this
emergency pr-essure would not. With regard to handling
category; h mical persons who handle closed packages
the manufactured would be counted under "enclosed process.
Persons Who package or transfer the unpackaged chemical would oe
counted In one of the following categories.
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^Controlled Release Process - The process is operated in a
* on trolled manner to minimize release of the chemical into
the workplace, kelease should generally be within prescribed
limits. These limits may be dictated Iby government regulations
or by company guidelines. If the chemical is vented outside
the plant, the process is a "controlled release" process. Uo
not count general space ventilation fans.
Upen Process - The chemical is routinely in direct contact with
the atmosphere (workplace or outside the 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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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
PCSTICIOES AND TOXIC SUBSTANCES
AC 30 802
memorandum
TO:
Air & Waste Management Division Directors
Environmental Services Division Directors
Toxic Substances Branch Chiefs
SUBJECT: Asbestos Reporting Rule Compliance Strategy
On July 30, 1 982, the Envi ronmental Protection Agency
published the Asbestos Reporting Rule. Attached is a copy
°f the the Compliance Strategy for this rule.
A draft of the strategy was circulated to the Regions
during July for comment. The final version of the strategy
incorporates those comments where appropriate.
If you have any questions, please call Pamela Harris
at FTS 382-5649.
i rector
ic Substances
Enforcement Division
cc:
Asbestos Coordinators
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ASBESTOS REPORTING RULE
COMPLIANCE STRATEGY
Pesticides and Toxic Substances Enforcement Division
image:
Asbestos Reporting Rule
Compliance Strategy
Overview
Requirements of the Rule
Regulated Industries
Compliance Issues
Obj ecti ve
Types of Violation
Industry Notification
Compl i ance'Moni toring
Compliance Monitoring Priorities
Neutral Administrative Scheme
Administrative Considerations
Program Management
Program Integration
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OVERVIEW
The purpose of the Asbestos Reporting rule 1s to obtain current
information about major aspects of asbestos manufacture and pro-
cessing to support the Agency's asbestos investigations into the
risks from asbestos (47 Federal Register 33198, July 30, 1982).
This rule is being developed in conjunction with analyses by the
Consumer Product Safety Commission (CPSC), the Occupational Safety
and Health Administration (OSHA), and the Mine Safety and Health
Administration (MSHA). The CPSC is studying asbestos in consumer
products, while OSHA and MSHA are reviewing the current occupational
exposure standard.
The Rule requires that persons subject to the Rule complete and
submit certain forms to EPA.
The objectives of the compliance strategy are to ensure that
o All persons who should report do report;
o Information is reported accurately;
o All reports are received by the Agency in a timely fashion.
Possible violations of the rule are failure to submit forms, failure
to properly complete forms, late reporting, and falsification of
i nformation.
Compliance monitoring activities will consist of reviewing notices
received, cross checkjng industry lists to determine that all
persons who are subject to the rule do report, investigating
reports of noncompliance, and inspecting the records of some
manufacturers importers and processors.
REQUIREMENTS OF THE RULE
The reporting requirements of the rule are outlined below:
A. Who must report (§763.65)
1. Persons who were miners, millers or primary processors
of asbestos or importers of bulk asbestos in 1981
(§763.56(a)) (EPA form 7710-36) must report.
2. Secondary processors of asbestos or importers of asbestos
mixtures (§763.65(b)) (EPA form 7710-37 parts I and II)
must report.
3. Persons who are importers of asbestos mixtures or
articles containing asbestos in 1981 (§763.65(c))
(EPA form 7710-37, parts I and III) must report.
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4.
Some persons described in parts 2 and 3 above, will be
selected in a sample survey to fill out EPA form 7710-36,
y e t c t c C f A \ \
(§763.65(d)).
B. What to Report
1. Submitters report all information required by the
appropriate sections of the EPA forms. (See the "Instruc^
tion Booklet -- Reporting Commercial and Industrial Uses
of Asbestos" printed with the rale in the Federal
Register for a discussion of the reporting requirements
and definitions.) EPA form 7710-36 and EPA form 7710-37
can be obtained by telephoning the Industry Assistance
Office {IAO) 800-424-9065.
2. Miners, primary processors and secondary processors must
report information "known or readily ascertainable" by
the respondent, including all information in a person's
possession or control, plus all information that a
reasonable person might be expected to possess, control,
or know, or could obtain without unreasonable burden
or cost.
3. Information already reported to CPSC may be referenced on
the form and,need not be submitted unless the respondent
has informed the CPSC of his objection to sharing data
with EPA in which case submission to EPA<is mandatory).
(Information for 1981 which was not required by CPSC
but is required by EPA must be submitted on EPA forms.)
C . Exemptions (§763.65(f))
1 Secondary processors of asbestos who process asbestos to
repair articles, construct buildiags or other similar
activities or to apply, assemble, install, erect, consume
or repackage the mixture without modification are exempt.
? Persons who are small manufacturers, processors or
Importers, as defined by §763.63(m) (i.e., who employed
no SSrethan 10 full-time employees at any one time in
1981) are exempt.
D. Schedule f<*r Reporting
U rSbestosm(§763!65(a)rEPAPfS%S7710-36 must be submitted
by November 30, 1982.
Processors and importers of asbestos mixtures
2" <SH3dsmi S (") report by October 30, 1982.
nmressors who are selected for additional
3" reporting shall submit the required data within 90_da£s of
the receipt of EPA notification to do so.
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E. Where to Report
Respondents will mall completed forms to
U. S. Environmental Protection Agency
Post Office Box 2070
Rockvllle, MD 20852
F, Confidential Business Information
Respondents may claim Information confidential by checking
the appropriate spaces on the form and signing the certification
statement.
REGULMLD INUUSlklLS ~~
Tufl „llla annH*c to oersons who are miners or primary processors
IS ,^lstosP mnoJtefs of bulk asbestos, asbestos mixtures or
of asbestos, importers w &nd certain seCondary processors of
C°PTSED has obtained a partial list of 3,131 persons to whom
asbestos. PTSED has Corporation of Bedford, Massachusetts
DreDared ?his ?i t'unJer a contract from EPA. The list contains the
'names of some companies which do "J* "b"J" " " al"
not differentiate between primary and |«ondairy pirocessors. In spite
of its flaws, it is an useful guide. Sources for the list are.
1. Dun and Bradstreet tape for four SIC categories.
2891 Adhesive and Sealants (968 establishments)
2952 Asphalt Felts and Coatings (350 establishments)
3292 Asbestos Products (325 establishments)
*?93 Gaskets, Packing, and Sealing Devices
(553 establishments)
2. Asbestos Information Association list.
T u.Mnnal Emission Standards for Hazardous Air Pollutants
(NESHAP) listing from EPA Compliance Data System.
4. NIOSH printout of asbestos-containing products.
5. Bureau of Mines mailing list.
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6. Asbestos/Cement Pipe Producers Association.
7. Friction Materials Standards Institute members.
8^ U.S. Customs List for 1980 for importers of asbestos.
9. State Industrial Directories.
The list is organized by Region. The appropriate section of the
list for each Region will be sent to the Regional Asbestos Coordi-
nator (RAC). The RAC may obtain the national list from PTSED,
if he needs it. PTSED will ask the RAC to help update the list
by recommending possible deletions and additions. The RAC may
wish to contact state agencies which regulate the asbestos industry
to obtain information to update the list. The list will also
be updated by adding the names and address of persons who request
the reporting form.
COMPLIANCE ISSUES ~
The objective of this compliance strategy is to ensure that all
persons subject to this rule file their reports in a timely and
accurate fashion, and that no persons subject to this rule fail
to report.
Types of Violation
There are four types of violations:
1. Falsification of reports.
2. Failure to report.
3. Incomplete reporting.
4. Late reports.
Falsification of Reports: Falsification of any of the items
required by the rule would lead EPA to draw incorrect conclusions
about the threat to health and the environment posed by the con-
tinued manufacture or import of asbestos.
Submission of a falsified form does not satisfy the requirements
of this rule under TSCA §8(a), and is forbidden by TSCA §15(3)(b)
Knowing falsi fication of information submitted to the government
is also a violation of 18 U.S.C. Section 1001 and is, or may be
a criminal offense. '
Failure to Report: Failure to submit a report, as required by
the rule, would greatly impair the Agency's ability to make
decisions concerning asbestos' effects on health and the environ-
ment. Failure to report is a violation of TSCA Section 15(3)(b)~
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Incomplete Reports: Incomplete reports only partially impair the
Agency's ability to regulate asbestos. If OTS can readily obtain
the missing information from the submitter, then no violation will
have occurred. OTS has decided to offer reporters two correction
cycles to complete their report. The "8(a) Asbestos Flow Process" (1)
details, the OTS policy with respect to correction cycles. However
if the submitter continues to withhold critical information, a '
violation of TSCA Section 15(3)(B) will have occurred.
Late Reports: Late reports impair the Agency's ability to compile
data on segments of the asbestos industry and will delay planned
analysis. Reports received later than 30 days past the deadline
for reporting or more than 30 days past any extension granted by
OTS will be referred to PTSED for enforcement response. (Exten-
sions may be granted by OTS for good cause. Reports submitted
within the extended time period will not be treated as violative.)
INDUSTRY NOTIFICATION ; ~ "
The proposed Asbestos Reporting Rule was published in the Federal
Register (46 F.R. 8200, January 26, 1981). Written comments were
solicited prior to May 27, 1981. Following that date there was a
20 day period during which EPA personnel were available to meet in
Washington, D.C., with interested persons. Comments were "received
and_responses to the comments are addressed in the final rule, in'
addition, articles about the rule have appeared in major trade
j ournals.
The list of companies described in the Regulated Industries sprtinn
were used as a mailing list to di stri bute~7FfTeT~FF~THe^rirre and th*>
required form. The Industry Assistance Office (800-424-9065) will
be available to answer any questions about the rule or the form.
j^uHKlANCE: MONITORING * —
Compliance Monitoring Priorities
There are four methods available to the Agency to detect violations
In order of practical application they are:
1. Reviewing forms received by the Agency for timeliness
accuracy, and completeness.
2. Cross-checking the list of asbestos miners, millers
importers and processors against reporters of forms'
received to detect failures to report.
3. Verifying reports by reviewing company records.
4. Investigating reports of noncompliance.
(1) "8(a) Asbestos Flow Process" is a document which outlines
the report processing procedures that Informatics General
Corporation, the OTS contractor, will use. These procedures
will detect late reports, incomplete reports, and some reporti
cVnVroV°Bra-nch.he " "°"ab,e fr°m the
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Reviewing Forms: The information required by this rule is to be
submitted on the appropriate prepared forms. All required infor-
mation should appear on the form. Using the procedures in the
8(a) Asbestos Reporting Flow Process", OTS and its-. contractor
Informatics General Corporation will process the forms. Unreported
information is easily detected and will be investigated. Late
reports will also be referred to PTSED. Information which appears
to be unsatisfactory will also be investigated. For instance,
the submitters may report unknown in several places on the form.
However, repeated use of "unknown" as a response is probably
unwarranted. The report processors will flag the report for
investigation if "unknown" is used in place of expected data.
If a submitter has not reported satisfactory and complete informa-
tion after OTS has allowed the submitter two opportunities to do
so, the matter will be referred to PTSED.
When OTS refers late or incomplete reports to PTSED, OTS will
describe the type of violation and certify that the report
received is in violation. When suspected violations are
referred, OTS will give the reasons for its conclusion that
the report is or may be in violation and recommend specific
Investigations which the Regions may perform. (For instance,
OTS may report that worker numbers are inconsistent and recommend
investigation of personnel records.)
Cross-checking List of miners, mi 11 ers , processors and importers.
The Agency has compiled a list of persons whon may be subject
to the rule. The Agency mailed a reporting package to each
person on the list developed by GCA and updated as described in
the Regulated Industries Section. The Agency requested recipients
of the package to inform the Agency if they are not subject to
the rule.
The Agency will treat non-respondents to the updated list in the
following manner. (Non-respondents are pers.ons who received a
reporting package but neither submitted the form nor informed
the Agency that they were not subject to the rule.)
August 30, 1982
October 30, 1982
November 30, 1982
December 14, 1982
J anuary 21 , 1 983
Effective date of the rule
secondary processors and importers of
asbesos mixtures report
Miners, millers, primary processors and
importers of bulk asbestos report
OTS (Chemical Control Division (CCD))
sends letter to non-respondents
reouesting either submittal of form
Sr notification to EPA that they are
subject to the Rule.
PTSED will send a list of persons who
have still not responded to each Region.
The Reqions will try to determine if
the persons who did not respond are subject
to the rule.
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If It can be determined that a non-respondent was subject to the
rule, the Regions will pursue appropriate enforcement response.
The Regions will inform PTSED of the results of its investigations.
PTSED will inform OTS (Information Control Branch) .of the results
of the Regional investigations.
Reviewing Company Records: Some companies which have apparently
complied with the rule will be randomly selected for inspection
to verify the information on their forms. The companies which
the Agency inspects will be chosen by computer using statistically
valid criteria. Other companies which are on the list but did not
submit a form will be randomly selected for inspection to verify
that they are not subject to the rule. (See Verification Inspection
Scheme.) ~ ~
Investigating Reports of Noncompliance: The Consumer Product
Safety Commission, state or federal agencies, current or former
company employees, or competitors may have information which
implies that a company is violating the requirements of the
rule. Information which comes to the attention of EPA Headquarters
will be transmitted to the appropriate Region for investigation.
In some instances, the case may be resolved by telephone or writ-
ten communication with the company. In others, inspection or
subpoena of the firm's records may be necessary. The "RAC should
inform PTSED of all alleged violations which come to his attention.
OTS will refer submitters of forms with unresolved problems to
PTSED. For example, companies which excessively report that
information is unknown and continue to refuse to submit the
requested i nformation after two opportunities will be inspected.
Companies that report "unknown" for more than 50% of the fields
where that response is permitted may be targeted for inspec-
tion. If the inspector, using routine inspection procedures,
is able to discover the information, then the company has not
reported "readily available information", and is in violation
of TSCA.
Neutral Administrative Inspection Scheme
There are two reasons for an inspection of a company.
1. Suspicion of violation based on a complaint, tip
or referral from OTS.
2. Verification of data submitted by companies. (See
Verification Inspection Scheme.)
Both types of inspections will be targeted by the Compliance
Monitoring Branch (CMB), PTSED on a quarterly basis. The.
Agency will investigate all allegations of violations. Alle-
gations which are received in the regions should be forwarded
to headquarters.
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CMB will begin targeting inspections 45 days after the appropriate
compliance deadline. This 45 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 the resolution of some reporting problems. Specifically the
targeting will conform to the following schedule:
\
December 14, 1982 Begin targeting inspections of Secondary Processors
January 14, 1983 Begin targeting inspections of Primary Processors
Targeting inspections of nonsubmitters will begin 45 days after
December 14, 1982, the date OTS sends letters to nonrespondents.
Thus, targeting of these inspections will begin on January 31,1983.
Each quarter, CMB will know how many inspections each Region will
have to perform to investigate allegations of violations. CMB
will then target inspections of companies which did not return
forms. This number will not exceed 10% of the inspections performed
during that quarter. (PTSED may increase this percentage if the
Agency discovers that a large number of persons subject to the
rule have not reported.) This is to verify that persons who did
not report are not in violation.
CMB will then ask the reports processing group in OTS to target
the remaining inspections using the selection program described in
the discussion nf the vpri fi cati on Inspection Scheme. At least 5
additional sites should also be selected tCMB 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 additional sites.
This procedure will target both processing sites and corporate
headquarters. If necessary, CMB should call the company's technical
contact reported on the form and determine whether the pertinent
records are available at the plant site or at corporate headquarters.
The inspection will be conducted at the location of the records.
While the rule has no recordkeeping requirements, relevant records
are likely to be kept for tax or business purposes, or to comply
with other Federal regulations. Section 11 of TSCA provides that
EPA has access to these records.
Verification Inspection Scheme
Verification inspections will be targeted from among all the sites
which submitted forms. As the EPA receives the reporting forms,
the data along with the document control number for each form will
be put into the computer. The computer data base will then contain
production and geographical information on all reporting sites. A
computer program will target inspections from an Initial universe
which consists of all sites which reported using a statically valid
selection criteria.. These criteria include geographical distribution
of the reporters, production volume, worker population, and type
of industry (miners, millers, secondary processors, etc.).
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a fow about 10%, of the verification inspections will investi-
gate companies which did not report but are listed as manufacturers
gate companies ,«hp«tos These inspections will be targeted by
the''ComDl lance Monitoring'Branch (CMB) from Headquarters. The
CMB Sill obtain from IA0 a list of sites which received forms or
listed elsewhere as manufacturers or processors of asbestos,
are listed eisewn° determine which sites on the list
^r^r/eiurn forms l^Ipantes Hmc are clearly no longer in
? ^ have already been Identified as violators of the rule
business or have aire® J .. f - non-reoorters. These inspections
will be deleted t the percent of the inspections performed
will be SO that the percent^otoJ comp/nl.es on the l1st of
non-reporters"which are in that Region. Otherwise the selection
will be random.
I nspecti ons
/¦. -j will be sent to the Region near the October 30,
Inspection Guidance w inspectors will compare the data on
1982, compliance date. fnes. Significant,
the form with the data in the dPtay orted and the data in the
unexplained Enforcement action should be taken
files represent t0 the Enforcement Response Policy,
against violators according to ine
with concurrence from Headquart
ADMINISTRATIVE r.nMSIDtka! IONS —
a
Program Management
OTS and PTSED Kave developed report Processing procedure^ that
will detect suspected vioiat ting> PTSED will also target
to report completely and Va fb d ,• n this document. The
inspections under the NAib aesu
Regions will conduct the msp
,.i ic irnoortant, The results of inspections
S?°l'OTS Wi th an es?imate of the overall reliability of
the data reported under this ru e.
x „ ot? ic necessary for violation detection. For
Assistance from 0 evidence to false reporting is the report
instance, a key piece o from 0TS wjll als0 help enforcement
that OTS received. Pe . ff1cance 0f discrepancies between data
personnel deter.,. ^'"tle m«. Consultation with OTS will
Unnecessary ?n most cases, so that only significant inconsistencies
are ?he subject of enforcement actions.
i nHi rate a possible violation are to be investigated
Any tips that "Jica P^ qt$ review of the form submitted by
f i rst at If further investigation is indicated, the
the al]®9ed viola ^ Region. Any violations detected by
case will be referr Reqions will be referred to the appropriate
Region3for*"enforcement response, with concurrence from Headquarters.
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Allocation of Responsibility
PTSED
o Write Policy and Strategy Guidance
o Act as liaison between Regions and OTS
o Concur with enforcement responses to violations
OTS
o Process reports (detection and certification of reporting
violations detected by the reporting process)
o Target verification inspections using computer program
Regi ons
o Perform inspections
o Determine violations
o Develop cases and litigation with Headquarters concurrence
Program Integration
Information received under this Rule may be useful to working
groups which are developing other regulations under TSCA for
asbestos. Release of data to these groups will be in conform-
ance with TSCA procedures for handling Confidential Business
Information.
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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 vrho 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 concern i ng th1 s St rategy please
contact Pamela Harris of my staff at FTS-382-5567.
ctor
Staff
Office o Substances
Attachment
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21 MOV 7983
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
0 ve rvi ew
Regulated Industry
Requirements of the Rule . . . .
Enforcement Objectives
Voluntary Compliance
Types of Violation
Violation Detection
Application of Detection Methods
Priorities
Administrative Considerations .
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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._Jist.
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 art entity which have as their
purpose, in whole or in part, the obtaining of a commercial advan-
tage. This 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 chemi cal s/mi xtu res 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 TSCA. Under §4(e), the
ITC is directed to revise the list every six months as it deems
necessary.
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 invo-lved
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 required 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 tosearch
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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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, 19"^ 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 teratogenicity, and the biological
and environmental fate tests listed in §716.10(h) through (j).
E xc I uded Repo rt i nq
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:
° studies or data which have been published in scientific
1iterature
° studies which have been submitted to EPA or studies
submitted to any other Federal agency without claims of
confidentiality
0 studies conducted or initiated by or for another person
who is subject to the requirements of the rule
° studies of chemical substances which are not on the
TSCA Chemical Substance Inventory
0 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 Reqi ster.
0 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 1 i sted in §716.10
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-4-
0 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
fixture 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.
° 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 be followed when submitting information.
How to Report
Submission of Copies of Studies .
Each study submitted under §716.6must be_accompanied by a
cover letter containing the following information:
° name, address, job title, and phone number of the
submitting official
0 the name and address of the company on whose behalf the
study was made
° 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 (CAS) Registry
Number, if known.
Submission of Lists of Studies
Lists submitted under §716.7 must include.
0 Onqoing 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 com-
pleti on.
° Studv 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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The lists submitted under §716.7 must be grouped by
chemical, including CAS number, if known, and must be accompanied
by a cover letter. The cover letter must contain the. name, job
title, address and telephone number of the submitting 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 §§716.6 and 71(5.7 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 §716.7 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 onecopy with confidential
material deleted. Claims of confidentiality must be in
accordance with §716.16 of the rule.
Enforcement Objectives
e thic strategy for monitoring compliance
t^provide^further'tncentlve for compliance .1th this ru!e.
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V~o1untary Compliance —
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
? fh, ° it is essential that industry be well informed of its
requirements Not only should enforcement efforts be directed
^rUr-ln, industry, of r.p.rt . n.n-ex..pt
program developed by OTS includes.
1.
2.
Notification to industry that the rule was been
promulgated and that compliance must occur with-
in 60 days. A summary of the rule's
was included in the notice.
UHU I w i 11
requi rements
Was I rio iuucu >1. —-
Notification to industry if and when additional
chemicals are added to the list in §716.17 of
the rules.
Types of Violations
: S U I Vfuiavi^/»w
Five potential violations of the §8(d) requirements in order of
P riori ty are:
° Falsification of data
0 Failure to submit copies
0 Failure to submit lists
° Failure to report on time
Failure to follow prescribed reporting procedures
iflcatio" nT — ~~
•r- ,«.<«« seriously threatens the Agency's efforts to
Data ^als1^ic]anwirnnmental and health effects. Violations
evaluate a substa^!Pcted by analyzing data submitted to OTS. While
of this sort are detectd,ta falsification is smaller than detec-
the likelihood of Je^Qlatfons, any case of suspected data falsifies-
ting other types of violations, y
t i on will be given highest priority.
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f a ilure 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 A in its
determination of whether sufficient data exists upon winch 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 test!ng under §4(a)- Therefore,
industry, through timely submission of existing studies, could
partially or in some instances totally obviate the need for further
testi ng.
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 as 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 timelv submission of health and safety studies is essential
to effi^erlt rulemaking under TSCA. Industry may fail to submit
adverse health and safety studies in a timely fashion in an effort
to delav eventual regulation of a chemical substance. The failure
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
particularchemical, it will be considered a failure to report or a
failure to report on time, as appropriate.
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-8-
Appli cation 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 TSCA test i ng .
Although compliance with the §8(d) rule is important to the
Agency, EPA does not intend to conduct an extensive affirmative
compliance moni tori ng program. The Compliance Monitoring Staff
(CMS) 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 gra*nts
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:
0 reports from employees of manufacturers, processors
and distributors of chemical substances involved in
the generation of such reports,
0 rpnnrt.s from cont ra ct o rs / co nsu 11 a nt s who conducted
health and safety studies for manufacturers, pro-
cessors and distributors,
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competitors who are subject to the requirement of §8(rt),
0 $4 GLP inspections, and
0 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.
Renorts 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 invest,-
gation.
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 testinq
Tabs of the requirements of §8(d). y
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 subje.ct 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
identified.
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§4 GLP Inspections
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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 5716.17 to determine whether' the 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 OTS.
Compliance Investigations
The most effective use of investigation as an enforcement tool
under 58(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 Agencyobtai
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 i n the following order of priority to insure
maximum discovery of violations:
0 Response to Evidence of Failure to Submit or Falsification
of Copies of Studies
° 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 (OTS) will:
0 Re responsible for determinations of the lateness of
a rpoort 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.
0 Be responsible for determinations of whether prescribed
reporting procedures had been followed.
0 Assist in the preparation of a subpoena when necessary.
° Provide CMS with current lists of chemical substances
or mixtures subject to § 8(d} reporting.
Compliance Monitoring Staff
The CMS will:
° Act as liaison with OTS, OLEC and Regions.
° Schedule any necessary inspections upon consultation
with the Regions.
° Assist in preparation of a subpoena when necessary.
° Provide Regional Offices with current lists of chemical
substances or mixtures subject to §8(d) reporting.
_Qffice of Legal and Enforcement Counsel
The Office of Legal and Enforcement Counsel (OLEC) will:
0 In conjunction with CMS and Regional Counsel, deter-
mine whether the evidence in a case is sufficient to
issue a complaint.
° Assist in the preparation of a subpoena when necessary.
Regional Offices
Regional Offices will:
0 Transmit any allegations received to CMS for action.
° Participate in field inspections, when necessary.
0 In conjunction with Headquarters, prepare and serve any
subpoena.
0 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 OTS 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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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
QSC 3 I B80
OFFICE OF ENFOftCEMENl
MEMORANDUM
SUBJECT: Guidance for Pilot TSCA Cooperative Enforcement
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, Maryland, Ohio,
Michigan and California to submit proposals. The.Regions
should work with these States to develop 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, 19 81.
If you have any questions, please contact John Martin
of my staff at 755-1075.
Agreements
TO:
Enforcement Division Directors
Air & Hazardous Materials Division Directors
Surveillance & Analysis Division Directors
A. or
Pestic ances
E
Attachment
cc: Toxics Contacts
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X. Introd uc tlon
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 FY 1981 in the form of Cooperative Enforcement Agreements.
The general objectives of this program are to:
Prevent or eliminate unreasonable risks to health
or the environment from certain chemical substarfces;
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 , 1979]. This
memorandum 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.
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II. 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 expanded * enforce-
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 the 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 State's ability to carry out its proposed program. The
applicant should address the following areas as well as any
others .which might pose.problems:
1. Authority to Conduct ..the Proposed Program
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.
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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 chemicals regulated
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 Federally regulated
chemical within the State. In addition State regulat-ions
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 without 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 be contingent on such authorization by the
State legislature.
*^3. Access to Confidential Business Information
A State should also describe the extent of its authority to
gain access to cenfidential business information, the specific
types of data considered confidential, and the extent to which
the State may disclose such confidential business information
to EPA to enforce TSCA.
All' afppri'catIon's'"stlo-uT<f Include atr opinion of ¦•the- State- Attorney
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 PCS 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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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
mofit 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.
Ill* 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 budge t over the period of ¦ the•agreement. 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
specifically, address 1) haw 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 considers
o The number of each type of PCB 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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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 will provide a basis for allocating resources in the
State's management plan.
!
In ranking its own priorities, each State should consider EPA
priorities and the respective capabilities of the Stat£ and
the EPA Regional Office to address most effectively the 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 following PCB User" Industr'ies-65%
Metals
Chemicals
Paper and Lumber
Mining
Transformer repair services
Automobiles
.Textile
Stone, Clay and Glass
Railroad
•Utilities
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,
—i 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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c) Spill Investigations-10%
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)**5Z
1) Inspection of records for completeness and discrepancies
2) Physical examination of inventories to determine com-
plance with storage and recordkeeping regulations.
e) Inspection of Manufacturing Facilities-5% — Determining
compliance with PCB manufacturing restrictions by
checki-ng: 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
Program may differ from State to State due to differences in
the number of storage facilities, disposal facilities, industries
wkich use PCB equipment,¦and the respective compliance monitoring
authorities and capabilities of EPA and the State. As a result
¦tfre-.-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
Qeeds of both the State and EPA. While States are encouraged
to engage in as many activities of the national program as
Possible, it is not necessary for a State to undertake all
activities to receive assistance.
Program Evaluation
A well managed PCB cooperative enforcement program requires
Periodic evaluation to ensure that limited resources are
u®ed effectively. The goal of the evaluation process is to
identify needed program adjustments that will foster the achieve"*
°ent of program objectives. Such adjustments could include
s*Ufting priorities, changing the level of compliance monitoring
activities or improving the training of enforcement staff.
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The State should develop a mechanism to evaluate Its proposed
PCB program. The description of the evaluation mechanism
should address the following:
o Functional Responsibility. It is essential that the State
clearly identify the person(s) responsible for performing
program evaluation.
Timing. The State should specify when program evaluations
will occur. Generally 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 specific
.evaluation tools, and .describe. ..how it- will use- these ..tools
to evaluate various program elements. Among the evaluation
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 h$s developed its list of priority areas
under the. agreement-it should • discuss 1 t-s - plan ¦ for
carrying out a balanced program to address each of these
areas during the period of the agreement. Where the nature
°f 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
the outputs does not permit numerical expression, a clear
narrative statement of the outputs should be included.
(Appendix III contains a suggested format for reporting
the projected outputs).
**• Proposed Budget
£ach appplication must contain the State's proposed budget
f°r the program. Expenditures must be supported by itemized
statements or fact sheets showing the cost for equipment,
Personnel, training, supplies, contractual services, etc.
EpA, when funding activities under the agreement, will
Slve 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
inspectional and analytical equipment. Non-essential equio-
!JaX*SUS?h"?* WU1 be giVSn l0W Prlority- The requirements
OMB Circular A-102 attachment 0 apply to all procurement
actions.
The State's share of the "total project cost" shall be 252
and may be paid in direct or allowable indirect contributions
by in-kind contributions. Expenses incurred by the'State '
for activities not specifically stated as grant commitments,
out related to PCB compliance monitoring activities, may be'
credited toward the State's contribution with Regional office
approval. These activities can either replace scheduled
commitments or be used in creating a new output category
specific to a particular State. An example of such an expense
aay be a portion of a State program funded solely by the State
and. not included -ii^.the cooperative agreement.
E* Conditions of the Cooperative 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:
"** Quality Assurance
a* During all inspections, investigations, and sample
collections performed un4er..the authprity.of
?SCA',' inspeit'ors shall 'adopt standard forms
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.
During all inspections, investigations, and sample
collections performed under the authority of State
law, State procedures and forms should be used.
During satapling, handling, shipping, storage and
analysis of PCBs 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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Saoples collected shall be analyzed by the State
laboratory or as specified in the application for
assistance, using EPA approved testing methods.
All violative samples should be verified by a check
analysis performed by a second chemist.
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 obt'ained
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 verification analysis. of ..the - 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. '
The EPA shall provide knowledgeable 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" as ' AOAC arid other-professi'onal' training
courses.
8* A State must meet certain procedural criteria for any
quality assurance (QA) program.* A State must:
Submit a QA Program Plan for participating State labs;
J1) Submit a QA Project Plan;
Provide for a QA System Audit;
iv) Submit QA reports as determined by the Regions
and Headquarters; and
Express the cost of the QA Program in a laboratory as
a percentage of the total analytical costs.
*^iai'mum QA requirements are explained more fully in Guidelines
Specif ic at ions Implementing Quality Assurance Requirmencs
I?r""EpA nftnfMKH and Interagency Agreements Involving Environment* i
SSurepents May 19, 1980. Copies ot cms document and additi^uT
^**^~speclf lc' QA materials .ay b. obtained from PXSE0 personnel.
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cX ~10~
2* Confidential Business Information
Soverning access by States to confidential
Star ? information shall be governed entirely by each
s own legislative authority in this area.
whlch doee not have its own authority to access
ta identified as confidential business data under TSCA
® all not request access to such information while corfductin»
inspections under an Enforcement Agreement. "
Case Preparation and Enforcement „ /"¦««
_
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
.cP9pe.rat.iy.e . agreement. , If the. evidence reveals a . possible
violation of only' the'"State* s'"PCB "law's", ' 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 completing" its investigation
the case shall be referred to.EPA for action. If the State
refers the case 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.
St'ate-'s-'halT"also' provide' witnesses for public hearings
and appearances court upon request of the EPA Regional office.
wbere evidence reveals a possible violation of Federal law
0ni7, the State shall immediately forward the information to
che EPA Regional office and prepare testimony and provide
witnesses as necessary.
State Reports
a« The State shall prepare and submit to the Regional
office quarterly reports of accomplishments 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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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 saon
after completion as possible.
J-v« Implementation of the FY1981 Grant Program
A* Summary of EPA Role
The EPA intends to determine the feasibility of developing
f. .coopejrat ive..prpg.ram wi th the .S tates f or. moni toring_. compliance
with selected provisions of 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:
Developing national priorities and strategy for ttie
PCB enforcement program;
2. Preparing guidance for implementing and managing
the program;
¦'Efetabiishdng'•criteria'for 'the awird- -of ''fund's''; and
. 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 EPA 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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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;
k. 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 responsibilitie
Of fK. O - J -x »--•« n
or the State and of EPA. Regional offices will also consult~with
PTSED during this negotiation stage.
C. Application Submission
The formal application for assistance will consist of an AodH
'or Federal Assistance EPA Form No..5700-33 and the PCB enf cati°n
Program plan l*?k r't IV'' NaVrVtive' Statement";'" Sample -rorttat
Appendix I). The "Part IV Narrative Statement" should includ
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 propos
The proposal must designate one agency with authority to cont^ *
or enter into interagency agreements with other agencies for th^
Performance of all necessary enforcement activities. Appiicaf-^e
oust be submitted by March 1, 1981. CIOna
®^ice 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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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 oi^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
to satisfy the concerns of'the Review Panel.
The Panel will evaluate the program set forth in each grant
application to determine (1) the consistency and compatibility
of the appplicant'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
rfc-sources- erpended.
. 5ased pn , t.his. evaiua.tion,.the Regional office should provide
written comments to the State on "its application wit Kin '30 da:Jrs
of EPA receipt of the application.
To aid the Regions and States in negotiating and evaluating
outputs under the cooperative agreement, a list of time factors
is provided in Appendix II.
E. Grant Award Process
PCB compliance monitoring enforcement agreements will be awarded
by the Regional office after concurrence by 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 requirements 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.
Headquarters 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 maintain
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)
^established in the orieinai 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 program will be conducted by "the EPA
Regional office with support from EPA Headquarters. Training
-wilil.. c.oafr.i-St -o-f instruction ift-'iaspecti-otial- a-nd:'sample •'•eoliectibri:
techniques, sanple analysis, case preparation, and handling of— 57"^ '
confidential business information,claims. Training will take :
place prior to the funding period when possible and will con-
sist o*f 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:
!• 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
Discuss any problems or unusual developments
affecting grant performance.
If. the -review indicates -deficiencies•in &ny.of the above areas
the review team should be prepared- to"-offer suggestions and *
guidance such as additional inspector or chemist training
renegotiation of grant outputs, etc.
The end-of-year review should also include an assessment <*f
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-ectional reports, the effectiveness
°f the program in its present state, appropriateness of prioritie
based on compliance monitoring results, quality of the program S
^ad aiiy. changes whi-ch. could., be made. in-^tJie program-«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
Headquarters by the Region.
* * 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
J. Regional Reporting
The Regions oust 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.
f
K. Modification, Suspension or Termination of the Agreement
The provisions and funding of the agreement must be mo'difled
by EPA and the State 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 Statement" - 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
Workyears cur-
rently comitted
to PCB compli-
ance monitoring
and enforcement
Projected workyears
under federally
funded PCB compllanc
monitoring and
enforcement program
Director/Administrator
Supervisory (Inspt/Chem.)
Inspectional
Chemist
Lab Techs
Clerical
Legal
H. Proposed statement of Work
* # u„rk should explain the overall objectives of the
Th. Statement J for ,chi.vlng th.«e objective., and how
f«S""?e " b. ,tiU«d. ">• following areas suae b.
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 agreement 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
gui dance:
A. Quality Assurance
B. Handling of Confidential Business Information
C« Case Preparation, an-d' Enforcement..
D. State Reporting
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appendix ii
TIME FACTORS
Activity Workhours to complete
Typical inspection 8
including collection
of 3-6 samples.
Preparation and ship- 4
ment of samples (per
inspection)
Preparation of pre- 16
liminary Inspection
Report
Preparation of Final 12
Field and Analysis
Reports
Sample Analysis
TIME REQUIRED TO PERFORM AN ANALYSIS FOR PCBs ON ONE SAMPLE
OF EACH TYPE OF SUBSTANCE.
Transformer Oils
Silicon, Oils
'Hydraulic Fluids
Soil/Sludge/Seliment
Water
Fish
Vegetation
10 hrs
12 hrs
15 4ir «:
32 hrs-
30. hrs
42 hrs
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
2
3
4
5
6
7
8
9
10
MULTIPLICATION FACTOR
1.06
1.12
1.18
1.24
1.5
1.75
2.36
2.42
2.48
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Appendix II cone
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 analytical 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 figures 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 tin and cost factors should be used as a guide In negotiating
HUQlbd TC OX ltlSp6C«Jk0tl8«
and. evaluating gran *PP multiplied by the time factors should
samples, analyses, • » work hours required under -the grant,
equal the % JuTtates, it should be assumed
To ensure equal t ronsists of 1800 work hours after allowing
that a normal work year consists or iovu
for leave and holidays.
..f.etors can be expected due to differences
Deviations from these etc., However, work hours grossly,
in,.travel. tl».; f noi'bi pWftt'ed. "SlgnifiL.t
in excess of these computed levels^™ ^ ^ ^ e0>pi>e4d
differences between the amoun forqeJ£ten8lve. travel time, or the.
must be. justified, e.g., either reduce the requested funding
applicant should be directed Qt8# If an applicant's
level or increase the °^put c^ cooputatlons the Regional office
commitments are in exces fl„ality of work is not suffering at the
must assure itself that the quaixty
expense of quantity of outputs.
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appendix hi
Projected (Actual) Outputs Under TSCA
Enforcement Grant"
Activity
1st Quarter
2nd Quarter 1 3rd Quarter I 4th Quarter 1 Total
1 1 1
Insp.
Samp
Insp.
Samp
Insp.
1
Samp 1
Insp*
1
Samp |
Insp. Samp
1. PCB User Industry Inspections
Automobiles
¦
1 1
Chemicals 1 I
!
1 1 1 1 1 1
Metals I j j : I 1 1
1 1 1 1 1 1
Mining 1 | | .1.1 1
I I 1 1 1
Paper and Lumber I | | | |
1 till
Railroads .1 1 | | 1
1 1 1
Stone, Clay and Glass III'
1
Textiles 1
1
' 1
1
Transformer repair Services 1
1
1
1
Utilities 1
1
1
2* PCB Disposal Facilities j
Inspections 1
1
1
1
j
3. PCB Storage Investigations I
1
1
1 ' J " 1
4. PCB Storage Facilities j
Inspections {
1
' 1 1
I
5. PCB Manufacturing II j 1111 I
. Facilities Inspections fill II II I
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* if*k '¦> UN I I is t A i LN v jia^Ji^ivicis i .nt_ rau i c.v- i a-\^c.ii
r t
\ ^•/'7 V WASHINGTON. D.C. 20460
\ *
K -V""
•jL<> I 9 lisbj
OFFICE- Of ENFOKCEMiT.T
memorandum
SUBJECT: Supplemental Guidance Procedures for State Inspectors
Acting Under the Authority of TSCA Section 11
TO: Enforcement Division Directors
Air & Hazardous Materials Division Di rector s_
Pesticides Branch Chiefs
Region I. III. V u IX
I. Introduction
The Pesticides and Toxic Substances Enforcement Division (PTStD)
is administering a Pilot Cooperative Enforcement Program under
the Toxic Substances Control Act (TSCA). Last December, PTSEv
sent guidance to the Regions for use in soliciting arant^propose;?
from States which expressed interest in participating. in this
pilot program. The draft applications indicate that most Sua :
'.-'ill conduct program compliance monitoring under Federal r&chsr
than State authority. Therefor*;, this Office has determined rr.cr.
supplemental guidance is necessz ry regarding the inspection Pro-
cedures to be foil owed by Stats inspectors. The purpose or t.'iis
guidance is to detail inspection procedures forState inspectors
acting under the authority of Section 11 of TSCA.
II. Background
The express language of Section IT, states the*. inspecutO:.
activities under TSCA are not limited t?A personnel. Any
"duly desiansted representative"' of the adir.im st rator may inspect
premises where chemical substances are manufactured, processes,
stored, or held, (Section 11(a)). Pursuant to fecuion 11U;,
the Administrator may designate State inspectors ^s- rupr^-un^. : ,c4
for the purpose of conducting PCS compliance a^tiv »i e s «
77 Section 10(a) and Section 28 authorize the proposed
cooperative enforcement program.
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- £.
The Office of Enforcement (OE) has decided that State
inspectors, while acting as representatives of the Administrator,
^hell not have access to TSCA Confidential Business Informacian
•CSI). This decision is based, in part, on Section 14 of TSCA
vltich limits access to CBI. Even though Section 14 allows
repr&sentati ves of the Atfmi n1"5trstor- to ofc-ta i n C81, the Agency
i .^concerned that State inspectors might not be subject to
criminal penalties for wrongful disclosure under Section 1'; (d).
Accordingly, State inspectors are not authorized to obtain
TSCA 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
rnay obtain CBI in other future programs.
III. Confidential Business Information
Pi scussion
Whenever the Agency makes an oral or thT
information from a business under TSCA,.Jh® Ju|Jn5!|,J??
riant to claim the information as uBI (40 CFR §2.2Q3(a}}.
The phrase "CBI" includes the concept of t^ad- secrets.
*ir*df>r this concent a business has the right wO limit use oi
mcVoSJrl Ul"u so that the buslnes* "•* °"«1"
or retaln business I?!,
information (40 CFR §2.ZUHe/v* v,» * , ,nrl
attaches to the information once 1 k .ents for CBI as^sho"-
that the in/ornatlon meets the raquIrenents for CB1 "
jn rPT Nnfce 2 The Agency implements special procedures
to sa?es«rS as"«t disclosure of CBI to unauthorized persons..
In the present PCS
-7nsP€_c4orf actins undrr r The gu?"" nf th« program should
euthorire-d-access tothls lim1tation> howaveP,
20t j;®.adyeCsely 3 Inticioated during PCB inspections since
Few CSi claims are anticipated au | n ield commerci£i
the information Experience with contract inspectors
advantages to competitors, txperien Agency
indicates few claims are made o ^
interfere with the majority of State Inspections.
Additional ly, State ^"tjons^nJhU
tnforcement Program may have du P te legis.
by both TSCA Section 11 an J ^"JJJ^tor may choose to
lation. In such effes»1(* .IJ aw, When conducting an
conduct the »n«P«t1on u not barred by
inspection under State law, tns
"2~. "Ihe 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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-3-
fSCA from collecting C3I and raay collect any information State
Jaw authorizes him to obtain. The inspection procedures
¦etcilsd in the following parts of this memo do not apply to
wtate_inspectors acting _unde.r__S_tAis_ PC31 aw.
Inspection Procedures
The TSCA Inspection Manual, (Volume 1, January 1980,
hereinafter, the "Manual"), 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 11. (Keadquarters will provide the Regions
with a sufficient number 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 conversation, the facility representative should be asked
to designate 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} £ n t ry
Under Section 11, the inspector is required to present
^h& owner, operator, or agent in charge of the facility with:
0 Proper credentials identifying.the holder as a duly
authorized representative of the BPA Adfn* ni strator; and
0 A written notice of inspection.
Additional entry requirements which must be followed are
found in Chapter 3 of the Manual. Since State inspectors acting
under Section 11 are not authorized access to CSI, they must
follow additional special steps# ihe additional steps vary
depending upon the availability of a facility official who has
authority to make CSI claims. The Manual should be disregarded
to the extent that its procedures for CBI differ from what appears
fcelow,
B) Opening Conference
The Inspector must present a TSCA Inspection Confidentiality
Notice (1n Manual Chapter 6, hereinafter, Notice) to the facility
°wner or aqent in .charge during the opening conference. This
Notice informs facility officials of their right to claim as CBI
information (documents, physical samples, or other material)
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collected by the inspector which meet the cr-:er1a shown on the
Notice, (detailed below). The inspector must ascertain whether
}the facility official to whom the Notice was given has the
authority to make CBI claims for the company. Tfre facility
official's- signsture-must be~obtained ~5t~ the" appropriate plate
on the Notice 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 CBI claims. The inspector must indicate what records or
samples need to be* seen to document compliance with the PCS
rule. The official should be informed that to claim any
information as CBI requires him to certify the following
for each piece claimed:
Your company has taken measures to protect the
confidentiality of the information and it intends
to continue to take such -measures.
The information is not, and has not been, reasonably
obtainable without your company's coasent by other
persons (other than governmental bodies) by use of
legitimate means (other than discovery based on a
showing- of special need in a judicial or quasi-
judicial proceeding).
The information is not publicly available elsewhere.
Disclosure of th-e 4nf crtnat-4o-n--wou4-d—e-ause-s-^bstanti al
ha it!) to your company 's- corapettuive position.
The above listed criteria for CBI appear on the Notice
presented to the facility official. If the facility official
chooses not to make a C8I claim, the inspection may proceed.
Alternatively, the facility official may make a CBI claim.
This is done by completing the Declaration of Confidential
Business Information form (hereinafter DCBI). As earlier
noted, each item claimed as CBI must meet all four of the
criteria on the Notice. The Inspector mus-t not argue with
plant officials who decide to roake CBI claims. The role of
the inspector 1s only to educate the facility official about
the CBI requirements. The inspector must regard the decision
of the facility official as final.
After a CBI claim 1s made, the inspector must determine
If the inspection objectives can still be met. This decision
Is guided by the scope of the CBI claim. For example, a facility
c.
d.
image:
-5-
Jfflcial might claim as CBI data which reflects the company's
Ital volume of PCB disposal. Under this c1rcumstance, the
Tspector should_reguest that the official send this documentary
evidence to the EPA regional office following usual C8I procedures:
a. Each page of each document should be stamped
"Confidential Business Information."
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 inspection.
c. The documents should be placed inside an'enve'lope al so
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
raay collect samples which document compliance with the PCB rule.
Inspectors should consult Chapter 3 of the Manual to assure that
all collected records and samples are properly identified. The
admissibility in an enforcement action of this evidence depends
ifpon these procedures being followed.
At the closing conferencethe inspector must issue a
receipt for all collected samples and documents. Any documentary
sv i dence which the facility sends to the Region should also
acknowledged on the receipt. The purpose of this receipt
^s to protect the Agency by showing ^hat_fajcility o^fficial_s
knew what documents and'saniples were tTfcen.' ~The cTdsIng
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
hot have the authority to make CBI claims for the company.
Although the facility owner and the agent In charge-are assumed
to have the authority to make CBI claims, it is also possible
that these officials will want to consult their attorneys
(or superiors 1n the case of agents in charge/regarding
this issue. The following alternatives exist for dealing
*1th these problems.
If no authorized officials are Immediately available,
the State inspector must temporarily terminate the Inspection.
Before leaving the facl11«y, the Inspector should confirm the
"^entity of officials who are responsible for CBI claims.
The State should then contact,, by letter, the responsible
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-b-
ovficial to determine if a CBI claim is going to be made.
I: the responsible official does not make a CBI claim, the
inspection can be re-scheduled and conducted by the State.
A11ernat.eljfIf the..compajiy_j}.ff-icia.]- asserts a CBI c-la-fm
in his response to the letter, the State inspectors may re-schedule
the inspection only if the inspection can be conducted so
that 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 followed to ensure that companies have a meaningfcrl oppor-
tunity to assert CBI claims.
IV. Summa r.y
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.
B) Where the State inspector conducts the inspection under
Federal authority (Section 11, TSCA):
1) Federal procedures must be followed (as detailed in
this memo);
2J. CBI 1. i m i t.a 11 o n s.. a p pi y_;
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.
tctor
pes stances
on
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C/5
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TSCA COMPLIANCE PROGRAM POLICY No. 6-PCB-1
Responsibility for Compliance with PCB Rule
TSCA Section: 6(e)
Issue:
If PCB-contai nr-ng equipment is owned by one party but is
used by another party, or is located on the property of someone
other than the owner, who is responsible for assuring that such
equipment complies with the laws regarding PCBs?
Pol icy:
In general, the Agency intends to hold the owners of PCB
containing equipment responsible for compliance with the PCB Rule
[40 CFR Part 7611 3¦ However, in all cases involving PCB use by a
person who does not own the equipment, or PCB equipment located
on property owned by a third party, the Agency will consider the
facts of each case to determine whether the user or landowner
should be held responsible for compliance, either in addition-
to, or instead of, the owner of the PCBs.
With one exception, the owner of PCB-contain1ng equipment
is responsible for compliance with the Interim Measures Program
(46 FR 16090, March 10, 1981). The exception is that a user who
is not the owner of. a PCB-containing transformer which poses an
exposure risk to food or feed products has the obligation in comply
with the Interim Measures Program until the user has informed the
owner that the transformer poses an exposure risk to food or feed
products.
Pi scussion:
Since the decision of the Court in Environmental Defense Fund
v. Environmental Protection Agency (EPF v. fcPAH 636 F. 2d 1267
(P.C. Cir. 1980), which invalidated the portion of the Agency's
regulations that characterized transformers, capacitors, and
electromagnets as totally enclosed, electrical equipment con-
taining PCBs can be used legally only by persons observing the
Interim Measures Program. That program, which primarily consists
of inspection and maintenance requirements for transformers,
appeared in the Federal Register on March 10, 1981 (46 Fr 16090).
The Court order which established the Interim Measures Program
stated that the owner of a PCB-containing transformers has the
obligation to comply with the Program, with one exception. A user
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- 2 -
who is not the owner of a PCB containing transformer which poses an
exposure risk to food or feed products has the obligation to comply
with the Interim Measures Program until the user has informed the
owner that the transformer poses an exposure risk to food or feed
products. Thus, the responsibilities for complying with this
program are clear.
The Interim Measures Program is not the only regulatory
requirement that must be met for PCB containing equipment. The
PCB Rule, 40 CFR Part 761, contains marking and recordkeeping
requirements for in-use equipment. Any uncontrolled discharge
of PCBs from the equipment may constitute improper disposal.
Additionally, leaking equipment is not totally enclosed and
thus cannot be used legally.
The PCB Rule does not contain any precise statement concern-
ing who is responsible for these requirements when the owner is
not the same person as the user. As a matter of compliance program
policy, the Agency intends to hold the owners of PCB-containing
equipment responsible for compliance with the PCB Rule. However, in
all cases involving PCBs used by a person not the owner, or located
on property owned by a person other than the owner of the PCBs, the
Agency will consider the facts of each case to determine whether the
user or landowner should be held responsible for compliance, either
in addition to, or instead of, the owner of the PCB-containing
equipment. In determining responsibility for compliance, the Agency
will consider, without limitation, the following factors:
o Written agreements between the parties. Contracts that
provide that the user will service the equipment, or
that the user agrees to comply with all laws argue in
favor of the user's being responsible.
o Prior actions by the parties. If one of the parties
has traditionally serviced the equipment, or taken
responsibility for compliance with regulations on the
equipment, this will influence the Agency's decision
on 1i abi1i ty.
o Access to the equipment. If one party has restricted
or no access to the equipment, this argues strongly
against that party's responsibility for compliance.
o Reasonable actions in emergencies. Even where the
other factors indicate that the owner is responsible
for regulatory compliance, the Agency expects users of
PCB containing equipment to act reasonably in the event
of a rupture or other environmental emergency. Thus,
the failure by a user to notify the owner promptly of
any rupture might subject the user to liability under
TSCA.
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- 3 -
As dictated by the specific instance, the Agency will also
consider any other pertinent factors In determining who should be
held accountable for compliance with the law. Any person who uses
PCB-containing equipment or has such equipment on his property, and
is uncertain about his responsibility for compliance is strongly
urged to contact the owner of the equipment to reach an agreement on
this subject. Such persons should also be remained that uncontrolled
discharges of PCBs may result in exposure of workers or members of
the public to PCBs. Such exposure may result in liability under
other Federal law (such as the Occupational Safety and Health Act)
or State or local law.
This memorandum is only a statement of compliance program
policy under TSCA. It is not intended to affect any rights or
liabilities any person may have under any other law or by virtue of
any contract. It also does not change the Agency's position that
persons may not enter into contracts which absolve them of their
responsibility or liability for violation of the PCB Rule. (See 44
FR 31 538-9, May 31 , 1 979, for the Agency's position 1n this regard. )
Key Words:
Responsibility for Compliance
Li abili ty
Penalti es
Unlawful Acts
Noncompliance
A. E. Conroy JtT, Director
Pesticides ancKToxic/Substances
Enforcement Division
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TSCA COMPLIANCE PROGRAM POLICY No. 6-PCB-2
Distillation, Solvent Extraction, Filtration,
and other Physical Separation Methods for PCBs
TSCA Section: 6(e)
ISSUE:
Does the physical separation of PCBs from liquids and solids
require EPA approval?
POLICY:
The physical separation of PCBs from liquids and solids
requires an approval if the use or disposal of these liquids and
solids avoids, or is alternative to,- the disposal requirements
that would have applied to the original material before
separation. An approval is required for physical separation
activities that can be construed to be part of, or an initiation
of a disposal activity. However, an approval is not required for
physical separation activities which process PCBs during
authorized servicing activities and reuse the processed materials
in equipment authorized for continued use in the PCB rules. An
approval is also not required for treatment of PCB contaminated
water where the treatment medium is properly disposed of and the
water is discharged in accordance with a HPDES permit.
DISCUSSION:
The PCB regulations (-4-0 CFR 761.60, 44 FR 31514) require EPA
approval of activities which dispose of PCBs and PCB Items. In
1979, a company approached EPA for a policy on the use of filters
for physically removing PCBs from transformers. At that time, EPA
interpreted "disposal" to mean only activities which alter or
destroy PCB molecules, while activities which physically separate
or concentrate PCBs from liquids or.solids were judged not to
constitute "disposal" and not, therefore, to require an
approval. Examples of techniques which physically separate PCBs
from liquids and solids include filtration, distillation, and
solvent extraction.
In 1982, after some experience with this policy, EPA realized
that the application of the above approach to physical separation
methods had the potential to create a major avenue for avoiding
the PCB disposal requirements. The PCB rules require specific
disposal options for materials containing PCBs. Unapproved
alternatives to these disposal requirements have the potential to
circumvent the rules and pose unnecessary risks.
EPA reviewed its interpretation of the PCB regulations
regarding physical separation and found th'at the original PCB
rules clearly do not exempt PCB processing.activities (including
physical separation techniques) from the disposal requirements.
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While activities which process or distribute PCBs for purposes of
disposal are not subject to processing and distribution in
commerce bans* such activities are subject to disposal
regulations. Section 761.20(c)(2) [emphasis added] provides:
"PCBs or PCB Items may be processed and distributed in commerce in
compliance with the requirements of this Part for purposes of
disposal in accordance with requirements of §761.60 [PCB disposal
requirements]."
Accordingly, unless an activity is authorized by the disposal
regulations, one must obtain specific approval for the activities
from the Regional Administrator or the Assistant Administrator for
Pesticides and Toxic Substances in accordance with section
761.60(e)(1982 ). Note, however, that it is not the intention of
this policy to require approval of physical separation activities
regarding the clean-up of leaks and spills of PCBs or to require
approval of inadvertant separations due to natural forces (such as
evaporation and gravity) that are not construed to be part of a
disposal activity. It is also not the intention of this policy to
require approval of physical separation activities that are part
of manufacturing processes that incidentally manufacture PCBs.
The physical separation of PCBs from products and waste streams in
manufacturing processes will be considered during the upcoming
rulemaking on the applicability of a regulatory cutoff for the
manufacture of PCBs ("the uncontrolled rule").
The following example of the use of a physical separation
technique is applicable. Capacitors must be disposed of by
incineration or by an approved alternate method equivalent to
incineration (40 CFR 761-.70). It is theoretically possible to
develop a capacitor disposal method the first step of which is to
separate the PCBs from the solid materials (e.g., solvent
extraction). The separation process, requires specific prior
approval by the Regional Administrator or Assistant Administrator
for Pesticides and Toxic Substances under section. 761.60(e) since
it is part of the disposal method but is not authorized under
section 761.60. If such a method were successful in completely
removing all detectable PCBs from the solids, the PCB-free solid
materials could later be salvaged without subsequent treatment or
EPA approval. Although the PCBs removed from the solid materials
and any unprocessed materials require incineration, it is also
theoretically possible to obtain approval to use a physical
separation technique to remove PCBs from the liquid materials in a
similar manner.
In contrast, a permit is not required to service electrical
equipment for purposes of reducing PCB concentrations. Physical
separation techniques can be used to service PCB-containing
electrical equipment as long as the processed materials are
ultimately returned to electrical equipment regulated under the
PCB rule. This type of servicing is authorized under 40 CFR
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761.30(a). Filtering PCBs from the dielectric fluid of
transformers and returning that fluid to the transformer is an
example of this type of activity. Because the processed liquids
and solids are returned or reused in regulated equipment, EPA
controls the ultimate disposition of all the processed materials
and no disposal requirements are circumvented.
Without an EPA disposal approval, processed liquids and
solids that formerly contained PCBs must be treated as if they
still contain PCBs and may not be distributed in commerce without
an exemption under section 6(e)(3)(B) of the Toxic Substances
Control Act (TSCA). Therefore, it is possible to physically
separate PCBs from liquids and solids without EPA approval as long
as these liquids and solids are treated (used, stored, disposed
of, etc) as if they still contain their original PCB
concentration. The PCB residue which results from physical
separation activities, as well as any materials not eventually
reused in regulated electrical equipment, must be disposed of in a
manner which complies with section 761.60. In the event the
separation method results in dilution of the PCBs, the original
PCB concentration determines the required disposal method.
A permit is not required to physically separate an orgarvic
phase from an aqueous phase of collected water (e.g. leachate,
lagoon water, storm water). The organic phase must be disposed of
according to the regulations for its concentration of PCBs* The
aequeous phase may be disposed of by means of filtration to remove
any residual PCBs (e.g. activated carbon) provided the filter
medium is disposed, of in accordance with the regulations for
solids containing that concentration of PCBs, and the water, if
discharged to navigable,waters, is discharged in accordance with a
National Pollutant Discharge Elimination System (NPDES) permit
granted under the Clean Water Act. Water cannot legally be
discharged from a point source without meeting the permit
conditions. Through this permitting process, EPA limits the
amount of PCBs in the water prior to discharge. Since EPA
controls the amount of PCBs released with the water, and also
controls the disposal of any PCBs physically separated from the
water (40 CFR 761.60), no additional approval under TSCA is
necessary or warranted. This form of physical separation may be
compared to the policy of not requiring approvals for physical
separation methods which result in all materials going to
controlled equipment or proper disposal under the PCB regulations.
Section 761.30 authorizes servicing of electrical equipment
for purposes of reducing PCB concentrations. After such
servicing, this electrical equipment may be reclassified if, after
at least 3 months of in-service use, the PCB concentration is
reduced below the appropriate level.
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See Also:
TSCA Compliance Program Policy No. 6-PCB-3
References:
Letter to SED, Inc dated April 2, 1981
Letter to Amtrak dated July 20, 1982
Key Word Headings;
Physical Separation, Disposal
A. E. Conroy ill Director
Compliance Monitoring Staff
Office of Pesticides
and Toxic Sttbstances
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TSCA COMPLIANCE PROGRAM POLICY Mo. 6-PCB-3
Residual PCBs in Processed Liquids and Solids
TSCA Section: 6(e)
ISSUE;
Are PCBs at concentrations less than 50 ppm in liquids and
solids that have been physically separated from higher
concentration PCB materials regulated for the purpose of disposal?
POLICY:
PCBs at concentrations less than 50 ppm in liquids and solids
that have been physically separated from higher concentration PCB
materials are regulated as if they still contain the original PCB
concentrations.
DISCUSSION:
Section 40 CFR 761.1 states that a substance containing less
than 5 0 ppm PCBs because of any dilution shall be treated for-
disposal purposes as though it contains its original PCB
concentration. This means that diluted PCBs would be subject to
EPA disposal regulations under 40 CFR 761.60, even though other
substances in concentrations less than 50 ppm are not.
Accordingly, if a PCB concentration under 50 ppm resulted from an
activity in which PCBs originally in concentrations above 50 ppm
were physically separated from other material, any separated PCBs
would be subject to EPA disposal regulations under
40 CFR 761.60. This includes those PCBs contained in a fraction
with a concentration less than 50 ppm (e.g. the "light" fraction
from a distillation process.)
A separator who is servicing electrical equipment may dispose
of the "heavy" PCB fraction according to 40 CFR 761.60 and return
the "light" fraction to the electrical equipment, in which case
all materials are controlled by the PCB regulation. In the
alternative (if he intends to produce a light fraction which will
not be disposed of according to the PCB rule or reused in
electrical equipment), the separator must obtain a disposal
approval from either the Assistant Administrator for Pesticides
and Toxic Substances or a Regional Administrator under 40 CFR
761.60(e). Only after the light fraction has been shown to
contain no detectable PCBs, however, can the activity be approved
by EPA as a disposal activity and considered an unregulated
material.
It has been suggested that the disposal regulations either do
not or should not apply to the light fraction unless the dilution
process was intentionally done to circumvent the EPA disposal
regulations. This interpretation is not correct. Section 761.1
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does not permit any dilution of PCBs to affect the applicability
of the PCD rules, unless the dilution is specifically provided for
in the regulation. The regulation also does not provide for
inquiry into the intent of the person performing the separation.
See Also:
TSCA Compliance Program Policy No. 6-PCB-2
References;
Letter to SED, Inc. dated April 2, 1981
Letter to Aratrak dated July 20, 1982
Key Word Headings:
Physical Separation, Disposal
f 5c to r
Cc Staff
Office of Pesticides and
Toxic Substances
Date
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TSCA COMPLIANCE PROGRAM POLICY No. 6-PCB-6
Allocation of Enforcement Liability for Violations of the One-Year
Disposal Deadline for PCB Articles or PCB Containers
TSCA Section: 6(e)
Issue:
How does EPA allocate enforcement liability among persons
who violate the requirement that PCB articles and PCB containers
be disposed of within one-year after being placed into storage.
Policy:
EPA will allocate enforcement liability for a failure to
dispose of PCB waste within one year after it is placed into
storage between the generator and the ultimate disposal facility
based on the contribution by either party to the violation. A
generator delivering PCB waste to a disposal facility later than
90 days before the end of the one-year disposal deadline will
be held liable if the disposal facility can not dispose of the
waste 1n time. A disposal facility receiving PCB waste later
than 90 days before the end of the one-year deadline will not be
held liable if the PCB waste is disposed of within 90 days.
Discussion:
Section 40 CFR 761.65(a) limits storage of PCBs designated
for disposal to one year. This requirement also states that "any
PCB Article or PCB Container stored for disposal before January 1,
1983, shall be removed from storage and disposed of...before
January 1, 1984. Any PCB Article or PCB Container stored for
disposal after January 1, 1983, shall be removed from storage and
disposed of...within one year from the date it was first placed
into storage."
The one-year time limit is intended to insure prompt
disposal of PCBs removed from service. However, the requirement
does not preclude some waste generators or intermediate waste
handlers from storing the waste for lonj^ periods of time (up to
12 months) before releasing It for ultimate disposal. As a
result, facilities which receive the waste for ultimate disposal
may not have sufficient time to dispose of the waste within the
one-year time limit.
EPA will allow facilities receiving waste a year after being
put into storage by the generator an additional 90 days after receipt
to dispose of the wastes without Incurring enforcement liability.
Because representatives of the two approved, landbased commercial
incinerators have provided technical data showing that PCB waste
is disposed of within 90 days after receipt by the facility, EPA
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has determined that ninety days is sufficient lead-time for the
disposer to receive and dispose of PCB waste. Therefore, if a
generator delivers waste to a disposal facility with ninety days
or more remaining in the one-year deadline, the disposer is
responsible for destroying the material before the deadline.
The liability shifts to the generator if the material is delivered
to the disposal facility with less than ninety days remaining in
the one-year allowed for disposal after storage. The disposer,
however, will share in the liability if he does not dispose of the
waste within ninety days from the date it is received at the dis-
posal facility.
EPA will utilize the scale below to allocate liability between
the generator and disposer.
WHEN DELIVERED TO WHEN DISPOSED LIABILITY
DISp0SER
GENERATOR DISPOSER
I
more than 90 days
before 1 yr. deadline
after 1 yr.
deadl1ne
none
enti re
penalty
II
90 days before
1
yr.
wi thi n 1 yr.
none
none
III
60 days before
1
yr.
1 mo. late
1/3 penalty
none
IV
30 days before
1
yr.
60 days late
2/3 penalty
none
V
last day
3 mos. 1 ate
enti re
penalty
none
VI
after I yr.
within 90 days
of receipt
enti re
penalty
none
VI I
after 1 yr.
after 90 days
of receipt
entire
penalty
enti re
penalty
See Also: TSCA Compliance Program Policy 6-PCB-7.
References:
Key Words:
PCBs, ultimate disposal facility, disposal deadline,
A. E. Conroly II/ Director
Compliance Mo<H^br1ng Staff
Office of Pesticides and Toxic Substances
Sate
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TSCA COMPLIANCE PROGRAM POLICY No. 6-PCB-7
Reference Date for Violations of the One-Year Storage for Disposal
Deadline for PCB Waste Resulting From Physical Separation.
TSCA Section; 6(e)
Issue:
What date will EPA use as a reference date for violations
of the one-year storage for disposal deadline for PCB waste
resulting from physical separation?
Pol i cy:
The one-year storage 11 mlt on PCBs resulting from physical
separation begins on the date the original PCB articles or PCB
containers were placed into storage for disposal. Drums or bins
containing PCBs resulting from physical separation shall be
required to be marked with the date correspondlng to the earliest
dated PCB material in the drum.
Discussion:
The PCB Storage for disposal requirements (40 CFR 761.65)
prescribe that any PCB article or PCB container "shall be removed
from storage and disposed of ... within one year from the date 1t
was first placed into storage." This provision is intended to
prevent long-term storage of PCB materials. To help Insure prompt
disposal, incoming PCB articles and containers are required to
be dated when they arrive at the storage facility (40 CFR 761.65).
Some disposal firms, particularly metal recovery and salvage
operations, physically separate the PCB-contam1nated core from
the article or container, recycle the metal portion after rinsing,
and store the remaining PCB portion In drums for disposal by
incineration or other treatment. The drums may contain PCB wastes
that result from physically separated articles or containers that
were placed into storage on different dates. There is some con-
fusion among physical separators regarding the correct date to apply
to these drums.
A similar problem arises at incineration facilities which shred
PCB articles and other solid materials and place these shredded parts
in drums before feeding them to the Incinerator. Components of many
PCB articles may be placed in the same drum.
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EPA has never articulated a policy regarding the storage for
disposal requirements and how they apply to PCB waste that results
from physical separation. However, the Agency has developed a
policy on disposal of PCBs that have been physically separated
from regulated liquids and solids. This policy has direct bearing
on the storage for disposal requirements.
EPA's position is that PCBs at concentrations less than 50 ppm
in liquids and solids that have been physically separated from
higher concentration PCB materials are regulated as if they still
reflect the original PCB concentrations. Operations such as dis-
tillation and solvent extraction have the effect of diluting the
PCB concentration in the original material. Section 40 CFR 761.1
states that a substance containing less than 50 ppm PCBs because of
any dilution shall be treated for disposal purposes as though 1t
contains the original PCB concentrations. This means that diluted
PCBs would be subject to EPA disposal regulations (40 CFR 761.60),
as well as the storage for disposal requirements (40 CFR 761.65).
PCB Articles have specific disposal requirements (40 CFR 761.60)
and a 11 parts of the article are controlled by the rule.
The date used as the starting date for the one year storage
for disposal deadline on a PCB article or PCB container prior to
physical separation shall be the earliest date of the PCB Items 1n
a container. Such PCB items must be disposed of within one-year
fron the earliest dated item.
See Also: TSCA Compliance Program Policy 6-CFC-6.
References:
Key Words:
PCB, physical separation.
i rector
CompliancVj4onHoring Staff
Office of Pesticides and Toxic Substances
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TSCA COMPLIANCE PROGRAM POLICY No. 6-CFC-l
Product Labeling for Both Essential and Non-Essential
CFC Aerosol Propeiiant uses
TSCA Section: 6(a)
Issue:
Will EPA initiate enforcement action against processors
of CFCs as an aerosol propeiiant for use in products whose
labeling bears directions for both essential and non-essential
uses?
Pol 1 cy:
CFC aerosol propeiiant products whose labeling bears directions
for both essential and non-essential uses create the rebuttable
presumption that those CFCs have been processed in violation of
the CFC regulations. The Agency will bring an enforcement action
against the processor, unless the processor can prove that th«
CFCs have been processed only for an essential use.
Discussion:
The Agency promulgated regulations under authority of the
Toxic Substances Control Act (40 CFR Part 762) stating that after
December 15, 1978, no person may manufacture, import, process,
process for export or distribute in commerce for processing any
fully halogenated chlorofluoroalkane (CFC) for any aerosol
propeiiant use except:
1. Use 1n an article which is a food, food additive,
drug, cosmetic or device exempted under 15 U.S.C-.
2602; or
2. The following essential uses listed 1n Part 762.58:
a. Mercaptan stench warning devices,
b. Release agent for molds used 1n the production of
plastic and elastomerlc materials,
c. Flying insect pesticides for use 1n non-residential
food handling areas except when applied by total
release or metered valve aerosol devices, and for
space spraying of aircraft,
d. Diamond-grit spray,
e. Non-consumer articles used as cleaner-solvents,
lubricants, or coatings for electrical or electronic
0Qtii pment,
f. Articles necessary for safe maintenance and operation
of aircraft,
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2 - 6-CFC-l
g. Uses essential to the military preparedness of
the United States as determined by the Administrator
and the Secretary of Defense.
h. Pharmaceutical Rotary Tablet Press Punch Lubricants.
(FR Notice Tuesday January 5, 1982 pp 148-49)
Since publication of the regulations, the Agency has also
Issued a special essential use exemption for the following:
Temporary exemption for Automatic Timed Release Insec-
ticide Dispensing Systems Used in Storage of Tobacco.
(May 19, 1982 to December 31, 1982)
The purpose of the regulations Is to ensure that CFCs are
not processed as aerosol propellants for any non-exempt/non-
essentlal uses. The Agency, however, has found CFC-propel1ed
aerosol products with labeling containing dlrectlorts for both
essential and non-essential uses. Although the CFC regulations
do not prescribe labeling for products containing CFCs processed
for non-essentlal/non-exempt aerosol uses, 1t 1s only reasonable
to presume that a product has been processed for any use directed
on Its label. Such labeling may Include the product container
label or any other collateral literature distributed with or a-part
from the product.
The Agency presumes that any.CFC aerosol-propelled product
bearing directions for a non-essential/non-exempt usehas been
processed for this unlawful use. A processor can rebut this pre-
sumption by showing that
a. 1t processes CFCs only for an Identifiable group of
users and that each of these users use CFCs only for
exempt uses, or
b. each of these users, by virtue of the nature of their
business, could use CFCs only for exempt uses, or that
c. by sticker labeling the non-exenpt/non-essentlal uses
which appear on the label have been fully nullified.
In the absence of such showings, the Agency will bring appropriate
enforcement action against processors of CFC aerosol propelled
products whose labels Include directions for both essential and
non-essential uses.
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3 - 6-CFC-l
See Also:
CFC Enforcement Response Policy.
References:
40 CFR Part 762.
Key Words:
Aerosol Propellant, CFCs, Chiorofluoroalkane, Essential-use.
A sctor
P Substances
)n
. —rr
AUS a q wo
Date
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