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pdfEmail Template for Distribution of TSCA Test Orders
[Each Order is Assigned a UIN by CDX when the Order is finalized for issuance]
Subject: Order Under TSCA Section 4(a)(2) for [Insert Chemical name] (CASRN [insert#])
Dear [insert POC for Company],
Attached is a Test Order issued to your company under section 4(a)(2) of the Toxic Substances Control
Act (TSCA), 15 U.S.C. 2601 et seq.
The effective date of this Test Order is Click or tap to enter a date. Your response options and the
timeframes for responding are specified in Unit IV.C. of the Order. Please note that your initial response
is due: Click or tap to enter a date (45 days after effective date of the order).
Your responses to the Order should be submitted through EPA’s Central Data Exchange (CDX)
application (https://cdx.epa.gov/), and you will receive a subsequent email that provides the Order
number that you need to use in responding to this Order via CDX. The Order contains further
instructions on how to respond to EPA. The EPA also encourages you to watch a recorded presentation
available on the TSCA Section 4 Test Order webpage (https://www.epa.gov/assessing‐and‐managing‐
chemicals‐under‐tsca/tsca‐section‐4‐test‐orders), which gives an overview on Orders issued pursuant to
TSCA section 4(a)(2).
If you have questions regarding this Order or the CDX system, please do not hesitate to email me, the
assigned manager for this Order.
Regards,
[Insert First Name Last Name of EPA Order Manager]
Data Gathering and Analysis Division (7410M)
Office of Pollution Prevention and Toxics
Environmental Protection Agency
1200 Pennsylvania Ave., NW., Washington, DC 20460‐0001
telephone number: (202) 564‐XXXX
email address: [email protected]
Paperwork Reduction Act Notice: This collection of information is approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB
Control No. 2070‐0033). Responses to this collection of information are mandatory under the Toxic
Substances Control Act (TSCA), 15 U.S.C. 2601 et seq. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The public reporting and recordkeeping burden for this collection of information is
estimated to be 137 hours for the average response on a per‐chemical basis. Under the PRA, burden is
defined at 5 CFR 1320.3(b). Send comments on the Agency’s need for this information, the accuracy of
the provided burden estimates and any suggested methods for minimizing respondent burden to the
Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania
Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not
send the completed form to this address.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
Order Under Section 4(a)(2) of the Toxic Substances Control Act
Chemical Subject to this Order:
Chemical Name: trans-1,2-Dichloroethylene
Chemical Abstract Service Registry Number (CASRN): 156-60-5
Docket Identification (ID) Number: EPA-HQ-OPPT-2018-04651
Recipients of this Order:
[Insert Company Name(s)]
Dear Sir or Madam:
This Order requires you and the other named manufacturer(s) and/or processor(s) of trans-1,2Dichloroethylene (CASRN 156-60-5) to develop and submit certain information for trans-1,2dichloroethylene, or otherwise respond to the U.S. Environmental Protection Agency (referred to herein
as “EPA” or “the Agency”). Failure to respond to this Order, or failure to otherwise comply with its
requirements, is a violation of section 15 of the Toxic Substances Control Act (TSCA), 15 U.S.C. §
2614. Any person who violates TSCA shall be liable to the United States for penalties in accordance
with section 16 of TSCA, 15 U.S.C. § 2615.
This Order is effective 5 calendar days after its date of signature. The timeframes and options for
responding are described in Unit IV. of this Order (Responding to the Order). Please note that the
initial response deadline as defined in Unit IV.C. of this Order (Schedule for Responding to the Order)
is calculated for you and included in the email that transmitted this Order to you. A subsequent email
will provide a company specific Order number for you to use in responses and communications about
this Order.
This Order is organized as follows:
I. Purpose and Authority ..................................................................................................................... 2
1
II.
Statement of Need ........................................................................................................................ 2
III.
Information Required by this Order ............................................................................................. 8
IV.
Responding to the Order ............................................................................................................ 12
V.
Consequences of Failure to Comply with this Order ................................................................. 18
VI.
References .................................................................................................................................. 18
To access the docket, go to https://www.regulations.gov.
1
Internet Address (URL) • http://www.epa.gov
VII. Paperwork Reduction Act Notice ............................................................................................... 19
VIII.
IX.
For Further Information Contact ............................................................................................ 19
Signature..................................................................................................................................... 19
Enclosure A - Equivalence Data ............................................................................................................... 21
Enclosure B - Cost Sharing ....................................................................................................................... 22
Enclosure C - Information Collected by the Agency and Recordkeeping ................................................ 23
Enclosure D - Order Recipient Selection Rationale ................................................................................. 26
Enclosure E - Resource for Reporting Occupational Exposure Data ....................................................... 27
Enclosure F - Dermal Hand Wipe Sampling – Solvents........................................................................... 30
I.
PURPOSE AND AUTHORITY
This Order is being issued under the authority of the Toxic Substances Control Act (TSCA), 15 U.S.C. §
2601 et seq. Under TSCA, EPA has the authority to issue regulatory actions designed to gather or
develop health and safety information and exposure information on chemical substances and mixtures,
and to control unreasonable risks associated with new and existing chemical substances. TSCA section 4
authorizes EPA to require the development of information related to chemicals and the use of prescribed
“protocols and methodologies” in order to inform EPA and other federal agencies about chemical risks,
which in turn will inform TSCA decisionmakers for purposes of prioritization for risk evaluation, risk
evaluation and risk management of those chemicals as necessary
This Order requires manufacturers and processors to develop and submit new information on trans-1,2dichloroethylene that is necessary for EPA to perform a risk evaluation under TSCA section 6(b).
II.
STATEMENT OF NEED
The basis for requiring the development of new information by this Order is described in this unit. This
statement of need, as required by TSCA section 4(a)(2), includes: A) The need for the new information;
B) How information reasonably available to the Administrator was used to inform the decision to
require the new information; C) Why issuance of this Order is warranted instead of promulgating a rule
or entering into a consent agreement; and D) Why the Agency is not requiring the testing of vertebrate
animals in this Order. Unit III.A. of this Order (Required Tests) indicates which tests apply
specifically to manufacturers and/or processors subject to this Order.
A.
THE NEED FOR THE NEW INFORMATION
This section serves to delineate what new information is being required in this Order and why such
information is needed for the risk evaluation of trans-1,2-dichloroethylene under TSCA section 6(b).
The Final Scope of the Risk Evaluation for trans-1,2-Dichloroethylene 2 includes the hazards, exposures,
conditions of use, and the potentially exposed or susceptible subpopulations the Agency expects to
consider in the TSCA section 6(b) risk evaluation for trans-1,2-dichloroethylene. EPA has used the
scope document and the conceptual models therein for workers and occupational non-users (ONUs),
consumers and bystanders, and environmental releases as a starting point for identifying information
needs under this Order. The conceptual models3 visually represent the exposures (pathways and routes),
2
https://www.epa.gov/sites/production/files/2020-09/documents/casrn_156-60-5_trans-12-dichloroethylene_final_scope.pdf.
During Scoping, EPA used the conceptual models to identify pathways and routes of exposure associated with
environmental releases which are under the jurisdiction of TSCA and no other EPA-administered statutes and associated
3
Page 2 of 32
receptors and hazards associated with the conditions of use of trans-1,2-dichloroethylene to humans and
the environment. For each exposure (pathway and route), receptor and hazard that is visually
represented, the EPA has identified the information needed to conduct a quantitative risk evaluation for
this chemical.
EPA received public comments on the draft scope documents for the 20 High Priority Substances
designated under TSCA in December 2019, including trans-1,2-dichloroethylene, that emphasized the
importance of conducting risk evaluations to a high degree of accuracy and developing conclusions of
high confidence to develop effective risk mitigation strategies that are specifically tailored to a condition
of use. With this goal in mind, EPA must seek additional information where there are data needs that are
not addressed by the available information necessary to conduct the risk evaluation of trans-1,2dichloroethylene.
EPA has identified the following information as necessary to conduct the risk evaluation of trans-1,2dichloroethylene. The list below identifies the information needs and provides context for the role that
each set of information plays in conducting robust chemical risk evaluations.
1.
Environmental Hazard:
Identifying hazards to aquatic and terrestrial organisms is needed to conduct a risk evaluation. EPA
used the conceptual model in the Final Scope of the Risk Evaluation for trans-1,2-Dichloroethylene
to identify the specific releases of the chemical, resulting exposure pathways, and relevant species as
they pertain to the testing scenarios in this Order. There are no relevant environmental hazard data
needs for trans-1,2-dichloroethylene.
2.
Occupational Exposure:
Information about occupational exposure pathways is necessary to evaluating risk to potentially
exposed subpopulations to this substance. The conceptual model in the Final Scope of the Risk
Evaluation for trans-1,2-Dichloroethylene identifies worker and ONU inhalation exposure, as
well as worker dermal exposure, as exposure pathways in the life cycle of trans-1,2dichloroethylene. More importantly, as identified in the scope document, EPA needs
occupational exposure data tied to the specific conditions of use the EPA expects to assess for
the risk evaluation. The relevant occupational exposure data needs for trans-1,2-dichloroethylene
are as follows:
a. Worker and ONU (as defined in the scope document) Inhalation Exposure:
i.
Air/vapor concentrations of trans-1,2-dichloroethylene in the worker and ONU
personal breathing zone and/or work area, and;
ii.
Occupational exposure information, such as the facility process description, process
parameters, job or activity description and corresponding title of worker or group of
workers performing each job or activity, the number of workers performing each job
or activity, daily duration of exposure to releases of trans-1,2-dichloroethylene from
each job or activity, and the rest of the monitoring parameters on occupational
inhalation exposure found in Enclosure E and in NIOSH Method 1003 (2003).
b. Worker Dermal Exposure:
i.
Absorption of trans-1,2-dichloroethylene on the skins of humans and animals.
regulatory programs and then made determinations on which exposure pathways should be included in the TSCA risk
evaluation.
Page 3 of 32
B.
ii.
Concentration on worker hands from vapor, mist, and spillage.
iii.
Account for evaporation and trans-epidermal water loss (skin surface vapor loss is an
indicator of the integrity of the skin barrier) of trans-1,2-dichloroethylene resulting
from dermal exposure as volatility and integrity of skin impact the load of the
permeant. Full details can be found in Enclosure F.
iv.
Occupational exposure information, including facility process description, process
parameters, job or activity description and corresponding title of worker or group of
workers performing a specific job or activity, the number of workers performing each
job or activity, daily duration of exposure to releases of trans-1,2-dichloroethylene,
and the rest of the monitoring parameters on worker dermal exposure found in
Enclosures E and F.
HOW INFORMATION REASONABLY AVAILABLE TO THE ADMINISTRATOR WAS USED TO INFORM
THE DECISION TO REQUIRE NEW INFORMATION
This section details the systematic review processes used by EPA to identify information that is not
currently available in existing literature. This section describes the systematic review process in three
parts: 1) Scoping and Conceptual Models; 2) The Systematic Review of Reasonably Available Existing
Information; and 3) Discipline-Specific Approach for Identifying Data Needs.
1.
Scoping and Conceptual Models
EPA’s assessment of data needs for risk evaluation began with the conceptual models in the
Final Scope of the Risk Evaluation for trans-1,2-Dichloroethylene. The conceptual models4
describe the identified exposures (pathways and routes), receptors and hazards associated with
the conditions of use of trans-1,2-dichloroethylene to humans and the environment. The Agency
performed a review of reasonably available information on the exposures (pathways and routes),
receptors and hazards identified in the conceptual models and identified potential data needs
related to environmental hazard and occupational exposure (specifically, worker and ONU
inhalation exposure and worker dermal exposure scenarios).
2.
Systematic Review of Reasonably Available Existing Information
Reasonably available information on the physical and chemical properties, environmental
hazard, and information on worker and ONU inhalation exposure scenarios and worker dermal
exposure scenarios during manufacturing, processing, distribution, use, and disposal have been
incorporated into EPA’s systematic review for this chemical. As appropriate, analogous
chemicals were identified and reasonably available information regarding analogous chemicals
(e.g., environmental hazard data) was also integrated into the systematic review.
The systematic review process began with searching peer-reviewed literature databases (e.g.,
Agricola, PubMed, Science Direct, ECOTOX Knowledgebase) for studies using trans-1,2dichloroethylene, synonyms and trade names. EPA also conducted a search for gray literature
(e.g., technical reports, reference books, dissertations, and other information not found in
standard, peer-reviewed literature databases), as well as public comments and information
4
During Scoping, EPA used the conceptual models to identify pathways and routes of exposure associated with
environmental releases which are under the jurisdiction of TSCA and no other EPA-administered statutes and associated
regulatory programs and then made determinations on which exposure pathways should be included in the TSCA risk
evaluation.
Page 4 of 32
submitted to the Agency under TSCA sections 4, 5, 8(e), 8(d), and For Your Information (FYI)
submissions.
The collected compilation of information was then screened for relevance. This process applied
title/abstract screening and/or full-text screening based on screening criteria developed a priori
for environmental hazard (Population, Exposure, Comparator and Outcomes (PECO)); physical
and chemical properties (Pathways and Processes, Exposure, Setting or Scenario, and Outcomes
(PESO)) or occupational exposure literature (Receptors, Exposure, Setting or Scenario, and
Outcomes (RESO)). See the Application of Systematic Review in TSCA Risk Evaluations5 (May
2018) for more details on this process.
As a result of the data searching and screening, EPA determined that reasonably available
information on physical and chemical properties of trans-1,2-dichloroethylene is adequate for
conducting a risk evaluation and, therefore, no further testing of physical and chemical properties
is needed. Due to the limited nature of the information that was identified for environmental
hazard and occupational exposures, EPA has determined that additional information needs to be
developed in order to complete the risk evaluation of trans-1,2-dichloroethylene.
3.
Discipline-Specific Approach for Identifying Data Needs
a. Environmental Hazard
As determined in the Final Scope of the Risk Evaluation for trans-1,2-Dichloroethylene, the
manufacturing, processing, distribution, use and disposal of trans-1,2-dichloroethylene can result
in releases to the environment and exposure to aquatic organisms. EPA expects to assess
environmental risks to aquatic vegetation, invertebrates and vertebrates and therefore requires
hazard data for each of these assessment endpoints. EPA also expects to assess organisms for
both aquatic and terrestrial hazard when those organisms transition between aquatic and
terrestrial ecosystems depending on the life stage evaluated (e.g., midges inhabit sediment
as larvae but mature into adults that inhabit terrestrial and aquatic ecosystems). Furthermore,
multiple exposure routes and media will be considered, if relevant to the environmental
conceptual models.
Evaluation of reasonably available information for trans-1,2-dichloroethylene included
consideration of existing data for trans-1,2-dichloroethylene and analogous chemicals for all
pathways identified in the environmental conceptual model in the Final Scope of the Risk
Evaluation for trans-1,2-Dichloroethylene. EPA identified nine analogues to trans-1,2dichloroethylene using EPA’s Analog Identification Methodology (AIM) software (see Table
1.0). EPA identified existing measured environmental hazard data for aquatic and terrestrial
species for trans-1,2-dichloroethylene and the identified analogues from the EPA’s ECOTOX
Knowledgebase (ECOTOX) and information submitted under TSCA (e.g., under TSCA sections
4, 8e, and FYI). To evaluate the fitness of a chemical analogue for assessing hazards of trans1,2-dichloroethylene, EPA used Ecological Structure Activity Relationships (ECOSAR) to
estimate aquatic hazards resulting from acute and chronic exposures to trans-1,2dichloroethylene and the identified analogues. ECOSAR estimates of environmental hazard to
aquatic organisms were considered as relevant information if estimates for toxicity resulting
from acute or chronic exposure were within a ten-fold difference of measured values from
available and relevant data.
5
https://www.epa.gov/sites/production/files/2018-06/documents/final_application_of_sr_in_tsca_05-31-18.pdf.
Page 5 of 32
As shown below in Table 1.0. environmental hazard data were identified for trans-1,2dichloroethylene and four of the nine identified analogues to assess all relevant pathways in the
environmental conceptual model in regards to exposed aquatic organisms, except for benthic
invertebrate toxicity data due to acute and chronic exposure via sediment. However, the Final
Risk Evaluation for Trichloroethylene has sufficient environmental hazard information for use as
analogue data for trans-1,2-dichloroethylene on benthic invertebrate toxicity data due to acute
and chronic exposure via sediment.
Table 1.0. - Measured aquatic environmental hazard data identified for trans-1,2-dichloroethylene
and identified analogues
Chemical Name
CASRN
trans-1,2Dichloroethylene
156-60-5
Ethene, 1,1,2-trichloro1,2-Dichloroethene(cis)
Tetrachloroethene
Hexachlorobutadiene
Trichloroethylene*
Tetrachloro-1,3butadiene
1,1,4Trichlorobutadiene
Pentachlorobutadiene
1,1,4,4Tetrachlorobuta-1,3diene
79-01-6
156-59-2
127-18-4
87-68-3
79-01-6
58334-795
83682-466
55880-778
36038-536
Environmental Hazard Data Availability for trans-1,2-dichloroethylene
Acute Exposure
Chronic Exposure
Fish
Pelagic
Invertebrate
Benthic
Invertebrate
via Sediment
Fish
Pelagic
Invertebrate
Benthic
Invertebrate
via Sediment
Algae
X
X
N/A
N/A
N/A
N/A
X
Analogues for trans-1,2-Dichloroethylene
X
X
N/A
X
X
N/A
N/A
N/A
X
X
N/A
X
X
X
N/A
X
N/A
N/A
N/A
N/A
X
N/A
X
N/A
N/A
N/A
N/A
N/A
N/A
N/A
X
X
X
X
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
An “X” or “N/A” denotes when environmental hazard data was or was not identified, respectively, for the specified chemical
for specific taxa and exposure durations.
*The Final Risk Evaluation for Trichloroethylene has sufficient environmental hazard information for use as analogue data
for trans-1,2-dichloroethylene.
b. Occupational Exposure
i.
Worker and ONU Inhalation Exposure.
Data sources on ONU inhalation exposure to trans-1,2-dichloroethylene were not located.
For worker exposure to trans-1,2-dichloroethylene, data sources identified during the
systematic review process detailed under Unit II.B.2. of this Order contain insufficiencies
which introduce uncertainty and potential bias into the risk evaluation.
Examples of insufficiencies include:
A lack of specific or range of values of interest for inhalation exposure parameters that
represent exposure patterns and variability associated with the specific and various
conditions of use that EPA expects to assess;
Use of unreliable protocols that lack clarity and completeness with respect to the
collected data (e.g., missing quality assurance information on background sampling,
reproducibility, and representativeness);
Page 6 of 32
Lack of data qualifier narratives, description of sampling and analytical methods used
(e.g., whether the results are representing area samples, personal breathing zone samples,
and usage of individual and/or in tandem sampling devices/ analytical instruments with
higher method detection limits than the required reported limit that are unreasonable for
the intended use of the information); and
Omissions of detection limits and/or deficiencies in defining reported detection limits.
Additionally, in TSCA risk evaluations, the source areas/exposure zones are determined by
professional judgment and dependent on the specific facility and could be judged by several
factors such as the chemical inventory, ventilation of the facility, vapor pressure and
emission potential of the chemical, process temperature, size of the room, job tasks, and
modes of chemical dispersal from activities. The lack of information on the near-field and
far-field values and exposure analysis reflecting the job responsibilities and exposure
scenarios specific to different types of workers and trans-1,2-dichloroethylene prevent
identification and verification of the worker exposures under various conditions of use.
ii.
Worker Dermal Exposure
The data sources identified during the systematic review process detailed under Unit II.B.2.
of this Order on worker dermal exposure to trans-1,2-dichloroethylene contain one or more
insufficiencies. Limited dermal data reported in the literature used non-standard protocols
without the description of methods, thereby preventing robust evaluation of whether the data
can be used to assess the specific and various conditions of use that EPA expects to assess.
Information on dermal exposure to trans-1,2-dichloroethylene in the workplace should
provide details on test conditions and protocols followed for intended purpose (e.g.,
condition of use). For example, a worker’s exposure is generally not uniform over time due
to routine and non-routine tasks performed throughout the day. In workplaces, tasks,
activities, work processes, and locations change over time, resulting in occupational
exposures that could vary both within a worker over time and between workers in the same
job. Both facility-specific data and job-specific data are needed to identify exposure patterns
and variability associated with the specific and various conditions of use that EPA expects to
assess. These insufficiencies in the existing information support the Agency’s decision to
require the development of new information on worker dermal exposure for trans-1,2dichloroethylene.
C.
WHY ISSUANCE OF THIS ORDER IS WARRANTED INSTEAD OF PROMULGATING A RULE OR
ENTERING INTO A CONSENT AGREEMENT
EPA is using its order authority under TSCA section 4(a)(2) to inform the risk evaluations under TSCA
section 6(b) in accordance with the requirements and timeframes for conducting those risk evaluations.
Use of this TSCA section 4(a)(2) authority will allow EPA to target known manufacturer and processor
recipients to obtain the needed information more quickly than if EPA were to issue a TSCA section 4
rulemaking or consent agreement.
D.
EPA DETERMINED THAT VERTEBRATE TESTING WAS NOT NEEDED IN THIS ORDER
EPA considered each of the reasonably available existing information types articulated in 4(h)(A), and
has determined that vertebrate testing is not needed for assessing the particular exposure pathways and
receptors discussed in this Order because reasonably available data, computational toxicology, or highPage 7 of 32
throughput screening methods and the prediction models of those methods are available and can be used.
The analysis for determining data needs in the environmental hazard assessment described in Unit
II.B.3. of this Order included use of acceptable NAMs, specifically EPA computational toxicology and
informatics tools, AIM and ECOSAR to identify analogues with existing toxicity information that could
fill ecological hazard data needs. For testing dermal absorption, EPA’s List of Alternative Test Methods
and Strategies6 includes new approach methods (NAMs), i.e., in vitro studies as alternatives to in vivo
vertebrate testing, that can be used to determine dermal absorption. Consistent with TSCA section 4(h),
EPA is requiring testing be conducted using the in vitro test method for determining dermal absorption,
in order to replace testing on vertebrates for this endpoint.
III.
INFORMATION REQUIRED BY THIS ORDER
This unit applies to Option 1: Develop the Information and Option 2: Submit Existing Information
(Units IV.A.1. and IV.A.2. of this Order).
A.
REQUIRED TESTS
This Order requires the testing of trans-1,2-dichloroethylene. The tests required by this Order are listed
in Table 1.1, as they pertain to manufacturers and/or processors (as identified in Enclosure D) and as
specified in the version of the test protocol/methodology current on the day this order is signed. The
Company individually, or as a member of the Consortium, must submit the testing below within the
timeframes specified in Tables 1.1 and 1.2.
The EPA Guidelines are available from the National Technical Information Service (NTIS), Attn: Order
Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel: 703-605-6000) and on the EPA’s Chemical
Safety and Pollution Prevention website7. The Organization for Economic Co-operation and
Development (OECD) guidelines are available on the web at https://www.oecd-ilibrary.org. The
National Institute for Occupational Safety and Health (NIOSH) test method is available at
https://www.cdc.gov/niosh/docs/2003-154/method-2000.html.
Once EPA has completed its initial review and accepted data identified in this Order, EPA will notify
the designated contact for the company or consortium subject to the Order to inform them that this Order
has been satisfied, which in turn will close out the Orders for the companies and participants in the
consortium subject to the Order.
EPA reserves the right to revise this Order to extinguish specific testing obligations where existing
information subsequently comes to the Agency’s attention that in EPA’s scientific judgment obviates the
need for specific test data required under the Order.
Table 1.1: Required Tests, Protocols/Methodologies
Test Name
Exposure
Occupational Inhalation Exposure at each
facility under your company’s control where there
is potential for exposure to Trans-1,2dichloroethylene
6
7
Protocol/
Methodology
NIOSH Method 1003
(2003)
Manufacturers†
Subject?
X if yes.
X
Processors†
Subject?
X if yes.
X
https://www.epa.gov/sites/production/files/2019-12/documents/alternative_testing_nams_list_first_update_ final.pdf.
http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.
Page 8 of 32
Test Name
Protocol/
Methodology
Dermal Hand Wipe Sampling-Solvents at each
facility under your company’s control where there
is potential for exposure to Trans-1,2dichloroethylene
Dermal Absorption: In Vitro Method using human
and animal skins*
Enclosure F
X
OECD 428 (2004)
X
Manufacturers†
Subject?
X if yes.
Processors†
Subject?
X if yes.
X
†Details of how companies were identified as manufacturers and processors of trans-1,2-dichloroethylene for this Order
are available in Enclosure D.
*The origin of the human and animal skin (gender, animal species, sites [e.g., abdomen, chest or upper leg], and hydration of
skin), thickness, and temperature to be specified by the test submitter as these factors influence the integrity of results.
References to Other Considerations for Conducting the Listed Test Guidelines*
Reference to Other Considerations
Applicable Test Guideline
Background and Special Considerations – Tests with Aquatic and SedimentOCSPP 850.1000 (2016)
Dwelling Fauna and Aquatic Microcosms
Background and Special Considerations – Tests with Terrestrial and Aquatic
OCSPP 850.4000 (2012)
Plants, Cyanobacteria, and Terrestrial Soil-Core Microcosms
Guidance Document on Aquatic Toxicity Testing of Difficult Substances and
OECD 23 (2019)
Mixtures
Guidance Document for the Conduct of Skin Absorption Studies
OECD 28 (2004)
Guidance Notes on Dermal Absorption
OECD 156 (2011)
Occupational Exposure Data Reporting resource
Enclosure E
*References, guidance, and information from additional sources could be considered, with EPA approval, during the
development of study plans when no standard operating procedure (SOP) is available to meet test objectives.
B.
STUDY PLANS
If you choose to develop the required information to comply with this Order, you must obtain and
review the required protocols/methodologies. You may not modify the required protocols/methodologies
unless you first consult with the Agency and obtain Agency approval of any planned modification prior
to submitting your initial study plan. The initial study plan is due to the Agency 75 days after the
effective date of the Order. A final study plan is due 60 days after the initial study is submitted. During
this time the Agency will review the initial study plan and provide input to ensure adequacy of the final
study plan.
Prior to initiating any test, the Company/Consortium must first address EPA’s input on the initial study
plan and receive EPA’s acceptance of the final study plan. EPA’s acceptance of a final study plan does
not constitute pre-acceptance of any future test results.
All testing must follow the EPA accepted final study plan. If problems occur during testing, the
Company/Consortium must request EPA’s approval before modifying the accepted final study plan.
You must also secure EPA’s approval prior to submitting the initial study plan, if you wish to use a
protocol/methodology not listed in this Order. Within your initial study plan, you must submit a detailed
description of the protocol/methodology you are requesting to use or your requested modifications of the
required protocol/methodology and your reason(s) for using a different or modified
protocol/methodology. Indicate whether and how the requested protocol/methodology is appropriate and
whether its deviations from the protocol/methodology required by this Order are such that they could
Page 9 of 32
alter the validity of the study. If EPA has concerns about the requested protocol/methodology or your
requested modifications of the required protocol/methodology, the Agency will inform you of concerns
that must be addressed before EPA will approve your request. If testing conducted according to a
requested protocol/methodology or requested modifications of the required protocol/methodology is
initiated prior to EPA approval, that testing will not satisfy the requirements of the Company under this
order. Development of information required by this Order which does not fully comply with the terms of
this Order may result in a violation of TSCA section 15.
EPA has identified the protocols/methodologies that must be followed to perform each required test.
They are listed in Table 1.1 and may include protocols/methodologies (also known as test guidelines)
from OECD or OCSPP/OPPTS. These protocols/methodologies are available via the Internet. It is
highly recommended that your final test report be submitted along with the data in the associated OECD
harmonized template format which can be located at https://www.oecd.org/ehs/templates/harmonisedtemplates.htm8. If questions and /or issues arise during Study Plan development, EPA encourages
consultation with the Agency prior to submitting the Study Plan.
The Study Plans must contain the following information:
8
1.
The Order number, excluding the unique 6-digit company number so as to protect each
company’s private access to the reporting module via CDX. This should look similar to the
following example with X’s used in place of the unique company number: TO-2020-0000XXXXXX-00-0. The remainder of the Order number should be identical to the number received
with this Order.
2.
Name of test to be covered by the test protocol/methodology.
3.
The name/number of the protocol/methodology identified by Table 1.1 in the Order which you
intend to follow, or a copy of the identified protocol/methodology with your modifications that
the EPA has approved, or a copy of the protocol/methodology you requested to use which EPA
has approved. If approval for the identified protocol/methodology with your modifications or the
use of a protocol/methodology you requested to use is not granted by EPA in time to be included
in the study plan, they must be referenced as "submitted and pending approval" and the final
protocol/methodology submitted later, once approved, in final form in an amended study plan.
4.
The rationale for any modification, or pending modification, of the identified
protocol/methodology. The rationales do not have to be listed in a separate document in the study
plan if they are included and clearly identified in the relevant protocols/methodologies.
5.
The identity and supporting data on the chemical substance to be tested including physical
constants, spectral and chromatographic data, chemical analysis, and stability under test and
storage, and test conditions required by the protocol. Per the respective protocol, the purity and
Certificate of Analysis of the test substance should be included.
6.
The sampling and analytical method that will be used, including whether the sampling method
was validated by an approved organization (e.g., NIOSH, OSHA, the American Society for
Testing and Materials (ASTM), the International Standards Organization (ISO) ) or an industrial
hygiene/analytical laboratory.
https://www.oecd.org/ehs/templates/harmonised-templates.htm.
Page 10 of 32
7.
For dermal exposure monitoring, the procedures used to optimize collection efficiency and
extraction of the test chemical to ensure that 60% to 125% of the test chemical will be analyzed
using the analytical method identified.
8.
A description of the preparation and processing of samples that will be done before sampling and
during sampling, including equilibration, weighing, calibration, test conditions (temperature,
humidity), number and type of samples, and identification of equipment and accessories used
(make, model, size/capacity, and operating conditions), including the specific sampling media
and sampling instruments that will be used.
9.
The sampling strategy that will be used for sample collection, including sample location, flow
rates, sampling time, field blanks and sample replication; the sample handling, storage and
transport procedures and whether they will be followed; the sample pumps and other instruments
and whether they will be properly calibrated with primary standard equipment.
10.
For exposure-related testing, the number of samples to be taken for each similar exposure group,
and how the workers or others will be selected for sampling (e.g., random sampling, select
workers with highest likelihood of exposure or some other statistically valid sampling strategy,
and other relevant information suggested by the American Industrial Hygiene Association
(AIHA)9). Also include the number of samples and length of sampling periods that will be taken
to ensure the results are statistically significant for worker and ONU exposure groups, and
indicate the statistical method used to demonstrate that the number of samples and length are
statistically significant. A list must be included to contain all job descriptions/titles and work
activities where workers and ONUs may be exposed and the total number of workers and ONUs
per shift and number of shifts per day, length of shifts, length of shifts if not full, number of
operating days/year for job description/title or work activities, and information on industrial
hygiene (IH) programs (e.g., respirator testing program).
11.
The specific number of quality assurance field samples (including sample volume for limits of
detection and quantification) and analytical QA/QC protocols to be followed (e.g., specific
number of field blanks, replicates of field samples, and replicate samples). NIOSH 95-117
(Kennedy et al., 1995) provides guideline for sampling and analytical method development and
evaluation.
12.
The rationale for any combination of protocols/methodologies; the rationale for species/strain
selection, dose selection (and supporting data), and route or method of exposure; description of
diet to be used and its source (including nutrients and contaminants and their concentration); for
in-vitro and/or ex-vivo test systems, a description of culture medium and its source; and a
summary of expected spontaneous chronic diseases (including tumors), genealogy, and life span.
13.
The name(s) and address(es) of the company(ies) sponsoring the test and whether they comprise
a testing consortium.
9
The strategy for assessing occupational exposures recommended by the AIHA for successful evaluation include the
following: a) collecting information and data to characterize the project site (or facility), process, operations, work force, and
environment; b) defining similar exposure groups by process, task, environment, and engineering controls; c) developing
exposure profile (e.g., by assigning qualitative ratings on exposure, health effects, and uncertainty to each similar exposure
groups); d) determine the acceptability of exposure and need for additional exposure monitoring; and e) re-assess the
exposure profiles and data collection, as needed (AIHA, 2015).
Page 11 of 32
14.
The names, mailing addresses, phone numbers, and e-mail addresses of the appropriate
individual(s) for EPA to contact concerning the planned test.
15.
The name of the testing facility and the names, mailing addresses, telephone numbers, and email
addresses of the testing facility's administrative officials, study director/project managers and
quality control officer responsible for ensuring the testing protocol follows appropriate quality
assurance and quality control procedures.
16.
Description of data and results that contain data supporting information that facilitate quality
review of the results, e.g., facility process descriptions, operation and process parameters,
sampling and monitoring parameters, sample populations, job description/title and the number of
workers for each job description or activity and the total daily duration of exposure, engineering
controls (e.g. local exhaust ventilation), room volume, air exchange rates, air changes per hour of
work area, ventilation rates, air speeds, work practices, and personal protective equipment used.
See Enclosure C for more information on monitoring data requirements.
If, after the study plan has been submitted or after testing is underway, you need to make a modification
to an identified protocol/methodology or need to use a different protocol/methodology, you must submit
a request to EPA to make these changes in your study and you must still meet the deadlines set out in
Table 1.2 and Table 1.3 for the relevant test or request an extension (see also Unit III.C. of this Order),
if needed.
For purposes of satisfying the requirements of this Order, you are required to follow the Good
Laboratory Practice (GLP) standards described in 40 CFR part 792, as specified in the CFR on the day
this Order is signed. You are also required to provide a statement of compliance with these GLP
standards when submitting information to EPA pursuant to this Order.
C.
EXTENSION OF DEADLINES
If you believe you cannot submit the required initial response, initial study plan, final study plan, or final
study information to the Agency by the deadlines specified in this Order and intend to seek additional
time to meet the requirement(s), you must submit a request to the Agency through EPA’s CDX portal as
soon as you know you may need an extension. Your request must include: (1) a detailed description of
the expected difficulty, including technical and laboratory difficulties, and (2) a proposed schedule
including alternative dates for meeting such requirement(s) on a step-by-step basis. Generally,
extensions will be granted only in cases of extraordinary testing problems beyond the expectation or
control of the manufacturer(s) or processor(s). Extensions will not be considered if the request for the
extension is not made in a timely manner, i.e. as soon as it is suspected that the deadline cannot be met.
D.
FEES FOR SUBMITTING INFORMATION
See 40 CFR § 700.45 for information concerning, when applicable, the requirement to pay a fee when
subject to an Order under TSCA section 4. An applicable fee as specific by 40 CFR § 700.45 shall be
paid in full no later than 120 days after the effective date of this Order by manufacturers that conduct
testing under this Order.
IV.
RESPONDING TO THE ORDER
Within 45 calendar days of the effective date of this Order, you, the Order recipient, are required to
respond to the Order through EPA’s CDX portal informing the Agency which of the five options you
Page 12 of 32
have chosen to comply with the Order. Follow the instructions in Enclosure C for submission to
EPA.
You must comply with this Order by the deadlines applicable to you in Unit IV.C. of this Order.
A.
FIVE OPTIONS FOR RESPONDING TO THE ORDER
You have five options from which to choose to comply with the Order. You will receive an e-mail from
EPA that provides two CDX Order numbers to submit your initial response using one of the five options
below. A company that is a manufacturer or both a manufacturer and processor of trans-1,2dichloroethylene will utilize the first CDX Order number, while a company who is only a processor of
trans-1,2-dichloroethylene will utilize the second CDX Order number to access the initial response
screen for this Order. Details of how companies were identified as manufacturers and processors of
trans-1,2-dichloroethylene for this Order are available in Enclosure D.
1.
Option 1: Develop the Information
If you choose to develop information in response to this Order, you must select this option in the CDX
portal form. For more information on the Order’s required tests, required protocols/methodologies, and
deadlines for submission of test reports see Unit III.A. and B. and Unit IV.C. of this Order.
Once EPA has completed its review of the submitted test reports and accepts the information as fully
complying with your testing obligations under the Order, EPA will confirm this through CDX
correspondence.
In considering whether to choose this option to comply with the Order, you should be aware that if other
companies, subject to the same Order for the same chemical(s), requested exemptions from testing and
those requests were granted due to your intention to test, those companies are responsible for
reimbursing you for their share of the final testing costs. See Unit IV.A.3. of this Order and Enclosure
B.
2.
Option 2: Submit Existing Information
If you choose to respond to this Order by submitting an existing study and/or other relevant information
that you believe EPA has not considered, your Initial Response in EPA’s CDX portal must include the
study and/or other relevant information, along with supporting rationale that explains how the study
and/or other relevant information meets part or all of the information described as necessary in Unit II.
of this Order.
EPA’s determination regarding whether the study and/or other relevant information satisfies part or all
of the Statement of Need will be based on the weight of the scientific evidence from all relevant
information reasonably available to the Agency. The Agency will notify you of its determination
through CDX. If the Agency determines that the study and/or relevant information is acceptable, EPA
will repeal all obligations of this Order that apply to the testing for which the existing information is a
substitute, with respect to all recipients of this Order. If the study was your only testing obligation under
the Order, all your obligations under the Order will be extinguished upon notification by the Agency.
If EPA determines that the study and/or relevant information is not acceptable, you must modify your
Initial Response in EPA’s CDX portal to choose one of the other response options in Unit IV.A. of this
Order within 10 calendar days of being notified by EPA. All remaining deadlines specified in this
Order will be extended by the number of days between submission of the existing information and
EPA’s rejection of the information.
Page 13 of 32
3.
Option 3: Request an Exemption
Any person required by this Order to conduct tests and submit information on a chemical may apply for
an exemption from such requirement (TSCA section 4(c)(1)).
EPA will grant a request for exemption from the requirement to conduct tests and submit information on
a chemical substance if:
1.
Information on an equivalent chemical has been submitted in accordance with a rule, order, or
consent agreement under TSCA section 4(a), or is being developed in accordance with such a
rule, order, or consent agreement, and
2.
Submission of information by the exemption applicant would be duplicative of information
which has been submitted or is being developed in accordance with such rule, order, or consent
agreement.
See Enclosure A for what EPA considers satisfactory equivalence data.
As explained in Enclosure B on Cost Sharing, persons who receive exemptions from testing have an
obligation to reimburse the person(s) who perform the required testing and submit the required
information for a portion of the costs incurred in complying with the requirement to submit such
information, and any other person required to contribute to a portion of such costs. Normally, this is
worked out by the parties involved, without the involvement of EPA. However, if agreement cannot be
reached on the amount or method of reimbursement, and the company who is entitled to reimbursement
requests in accordance with the procedures in Enclosure B that EPA order reimbursement, the
Administrator shall order the person granted the exemption to provide fair and equitable reimbursement.
See TSCA section 4(c).
An exemption request must be submitted through the CDX portal and contain the following:
1.
The Order number, the chemical identity, and the CAS No. of the test substance subject to this
Order on which the application is based.
2.
The specific testing requirement(s) from which an exemption is sought.
3.
The basis for the exemption request when another company(ies) has/have submitted the
information or is developing information for an equivalent chemical pursuant to a TSCA section
4(a) rule, order, or consent agreement. Your request must identify the company(ies) that
submitted or is/are developing the information.
4.
The chemical identity of the equivalent chemical (the test substance in the information submitted
or being developed) on which the application is based.
5.
The equivalence data specified in Enclosure A.
6.
The name, mailing address, telephone number, and e-mail address of applicant.
7.
The name, mailing address, telephone number, and e-mail address of appropriate individual to
contact for further information.
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8.
A Statement of Financial Responsibility: The following sworn statement (i.e., signed and
notarized) must accompany each request for an exemption:
9.
“I understand that if this application is granted, I must pay fair and equitable reimbursement to
the person or persons who incurred or shared in the costs of complying with the requirement to
submit information and upon whose information the granting of my application was based.”
EPA’s grant of an exemption is conditional upon the completion of the required tests according to the
specifications of this order (or other applicable rule, order or consent agreement), including any
modifications approved by EPA. If the Agency subsequently determines that none of the companies
identified in the exemption request has complied with that rule, order, or consent agreement, the Agency
will provide notice through CDX of its intent to terminate the exemption. Within 30 days after receipt of
such notice, the exemption holder may submit information in the CDX portal either to rebut EPA’s
preliminary decision to terminate the exemption or notify EPA of its intent to develop the required
information pursuant to the specifications established in the Order and any modifications approved by
EPA. If the exemption holder submits information to rebut EPA's preliminary decision to terminate the
exemption, then EPA will notify the exemption holder of its decision whether to terminate the
exemption and provide the exemption holder an opportunity to request a hearing prior to issuing a final
decision to terminate the exemption.
If you receive the Agency’s decision to terminate the exemption, you must resubmit the initial response
in accordance with one of the options described in Unit IV.A. of this Order within 30 calendar days of
receipt of the Agency’s decision to terminate the exemption, including as applicable the information
required under Unit IV.B. of this Order, unless before that date EPA has received your request for a
hearing in accordance with the procedures provided in the notification. Failure to timely resubmit the
initial response or a hearing request will constitute a violation of this Order and of TSCA section 15(1).
If you submit a request for a hearing, you will not be required to resubmit the initial response until and
unless subsequent to the hearing EPA rules that the exemption is terminated, or you withdraw the
hearing request.
If EPA repeals a testing obligation pursuant to Unit IV.A.3. of this Order, the corresponding exemption
will be extinguished, as the exemption will no longer be necessary. In such a situation, companies who
requested an exemption from that specific testing obligation are not required to reimburse the company
that submitted existing data.
4.
Option 4: Claim that You Are Not Subject to the Order
You may claim that you are not subject to this Order if you do not manufacture or process the
chemical(s) identified on page 1 of this Order or you believe the Order was otherwise sent to you in
error. An explanation of the basis for your claim, along with appropriate supporting information to
substantiate that claim, must accompany your Initial Response in the CDX portal so that EPA can
evaluate the claim. If EPA cannot verify your claim, the original requirements and deadlines in this
Order remain. If your claim is approved, EPA will notify you that you are not subject to this Order
through CDX correspondence. EPA expects to provide such notification within 50 days of the effective
date of the Order.
5.
Option 5: Cease the Manufacture or Processing of the Chemical
If, within 90 days of the effective date of the Order, you intend to cease the manufacture of the
chemical(s) for which you are required by this Order to submit information, you may satisfy the
requirements of this Order by informing the Agency in your Initial Response in the CDX portal that you
Page 15 of 32
intend to cease manufacture (including import) or process within 90 days of the effective date of this
Order. You must also attach a letter in CDX which includes the following certifying statement: “I certify
that the statements made in this letter are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under
applicable law.” The letter must be signed by an authorized representative of the company and include
the representative’s name and title/position in the company. Failure to cease manufacture or process
within 90 days of the effective date of this Order will constitute a violation of this Order and of TSCA
section 15(1) and may result in liability under 18 U.S.C. §1001.
If you choose to respond to the Order by ceasing manufacture and/or processing, and then resume
manufacture and/or processing of the chemical, you must submit a new response to this Order upon
resumption. In the event that EPA ceases work on a risk evaluation for trans-1,2-dichloroethylene, the
Agency may withdraw this Order.
B.
INSTRUCTIONS IF YOU CHOOSE TO PARTICIPATE IN A CONSORTIUM
If you choose to form or join a consortium to share in the cost of developing the required information,
you (as well as the other participants of the consortium) must individually in CDX, state your intention
to participate in a testing consortium for each specific chemical and specific test.
For your obligations under this order to be satisfied, the designated lead for the consortium must submit
a consortium response to EPA through CDX for the consortium. The response must confirm the
formation of the consortium, identify its member companies, and list the testing obligations that the
consortium plans to fulfill on behalf of each company by indicating each specific test. The letter must
also include contact information for the designated lead of the consortium, who must be domiciled in the
U.S. The designated lead for the consortium must submit the Initial Response and required information
on behalf of the consortium and its member companies by the deadlines listed in Unit IV.C. of this
Order Submissions made on behalf of the consortium must be in accordance with instructions in
Enclosure C. After the results of the last required test of the Order is submitted and EPA accepts the
information as complying with the Order, or EPA accepts existing information submitted by the
Consortium, EPA will then provide notification of compliance with the Order to the Order Recipients
and the designated lead of the consortium.
Even if you agree to jointly submit the information as part of a consortium, each Order Recipient is still
required to comply with the Order and is individually liable in the event of any failure to comply with
the Order. If the consortium fails to submit the information or meet any of the requirements of the Order
on your behalf, you will be in violation of the Order unless you submit the required information or meet
the requirement individually.
The Agency has provided a list of the manufacturers and processors that have received this Order at the
top of this Order in the Summary Information section. This list of manufacturers and processors can be
used to help Order Recipients form a consortium to jointly develop information, consolidate testing and
share the cost of testing. Information on cost sharing is provided in Enclosure B.
C.
SCHEDULE FOR RESPONDING TO THE ORDER
Tables 1.2 and 1.3 present the deadlines in chronological order for completing the required actions under
this Order if you chose Option 1: to develop the information or Option 2: to submit existing information.
Table 1.2: Deadlines for responding to the order if you chose Options 1 or 2
Deadline
Option 1:
Page 16 of 32
Option 2:
Develop the Information by
Testing
45 days after effective date of order
75 days after effective date order
135 days after effective date of order
Submit Initial Response and indicate
if joining a testing consortium
Submit initial study plan(s) for tests
to be conducted
Submit final study plan(s) for tests to
be conducted
Submit Existing Information
Submit Initial Response and
submit existing information and
indicate if joining a consortium
N/A
N/A
Table 1.3: Deadlines for submitting final test reports for each required test if you chose Option 1
Test Names
Protocols/
Methodologies
Deadlines to
Submit Final
Reports to EPA
Exposure
Occupational Inhalation Exposure at each facility under your
NIOSH Method 1003
8 months after effective
company’s control where there is potential for exposure
date of order
Dermal Hand Wipe Sampling-Solvents at each facility under
Enclosure F
9 months after effective
your company’s control where there is potential for exposure to
date of order
1,1,2-trichloroethane
Dermal Absorption in vitro method using human and animal
OECD 428
12 months after effective
skins*
date of order
*The origin of the human and animal skin (gender, animal species, sites [e.g., abdomen, chest or upper leg], and hydration of
skin), thickness, and temperature to be specified by the test submitter as these factors influence the integrity of results.
Pursuant to TSCA section 4(b)(1)(C), the Agency considers these deadlines to be reasonable because
they are based on estimates EPA obtained from up to nine testing laboratories for the time needed by the
laboratories to complete tests according to the required test protocols and to analyze results. Companies
are encouraged to submit study reports as soon as possible, they need not wait for the final deadline date
to submit.
D.
CONFIDENTIALITY
Under TSCA section 14(b)(2), health and safety studies submitted under TSCA and data reported to or
otherwise obtained by the Administrator from health and safety studies are not protected from disclosure
if the studies and data concern a chemical that is offered for commercial distribution, or for which
testing is required under TSCA section 4 or notification is required under TSCA section 5. However,
TSCA section 14(b)(2) does not apply to information that discloses processes used in the manufacturing
or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture
comprised of the chemical subject to the Order. Therefore, some or all of the information in the studies
required to be submitted under this Order might not be eligible for TSCA confidential business
information (CBI) protections.
Information submitted under TSCA that you wish to have EPA protect as CBI must be clearly identified
as such when submitted. For sections of the report that are claimed to be CBI, the report must be
accompanied by a sanitized version of the report only removing the specific CBI content. When
claiming and certifying information to be CBI, you must state the following:
“I hereby certify to the best of my knowledge and belief that all information entered on this form
is complete and accurate.
Page 17 of 32
I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for confidentiality made with
this submission, all information submitted to substantiate such claims is true and correct, and that
it is true and correct that
(i) My company has taken reasonable measures to protect the confidentiality of the
information;
(ii) I have determined that the information is not required to be disclosed or otherwise made
available to the public under any other Federal law;
(iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause
substantial harm to the competitive position of my company; and
(iv) I have a reasonable basis to believe that the information is not readily discoverable
through reverse engineering.
Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. §
1001.”
In addition, information claimed as CBI must be substantiated upon submission, with the exception of
information described in TSCA section 14(c)(2). Guidance for substantiating CBI claims may be found
at https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations10.
Failure to follow the statutory requirements for asserting and substantiating a CBI claim may result in
the information being made available to the public without further notice to the submitter.
When a claim of CBI under TSCA section 14 is approved by EPA, the Administrator will generally
protect that information from disclosure for 10 years (unless the protection from disclosure is withdrawn
by the person that asserted the claim), whereupon the claim must be reasserted and re-substantiated if
the submitter wishes to maintain the CBI claim. In certain cases, EPA may review claims prior to the
expiration of the 10-year period.
Under circumstances stated in TSCA section 14(d), EPA may disclose information approved as CBI to
appropriate persons including Federal and State authorities, health and environmental professionals,
poison control centers, emergency responders, and other appropriate persons.
V.
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS ORDER
Failure to comply with any of the requirements in this Order is a violation of TSCA and could subject
you to civil and/or criminal penalties under TSCA section 16, 15 U.S.C. § 2615 as modified by the
Inflationary Adjustment Act. Each day that failure to meet the requirements continues constitutes a
separate violation.
VI.
REFERENCES
The following is a listing of the documents that are specifically referenced in this Order. The docket
includes these documents and other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even if the referenced document is not
10
https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations.
Page 18 of 32
physically located in the docket. For assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1.
van Wendel de Joode, B., Tielemans, E., Vermeulen, R., Wegh, H., & Kromhout,
H. Dermal exposure assessment to benzene and toluene using charcoal cloth pads. Journal of
Exposure Analysis and Environmental Epidemiology (2005), 47–50r 2005 Nature Publishing
Group
2.
Kennedy, E.R., Fischbach, T.J., Song, R., Eller, P.M. and S.A. Shulman. 1995. Guidelines for
Air Sampling and Analytical Method Development and Evaluation. Department of Health and
Human Services, Public Health Service, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health, Division of Physical Sciences and Engineering
DHHS (NIOSH), Publication No. 95-117, Cincinnati, Ohio.
3.
National Institute of Occupational Safety and Health. Method 1501, Hydrocarbons, Aromatic.
NIOSH Manual of Analytic Methods Fifth Edition, 2020.
VII.
PAPERWORK REDUCTION ACT NOTICE
This collection of information is approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act, 44 U.S.C. § 3501 et seq. (OMB Control No. 2070-0033). Responses to this
collection of information are mandatory under the Toxic Substances Control Act (TSCA), 15 U.S.C. §
2601 et seq. An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The public reporting
and recordkeeping burden for this collection of information is estimated to be 137 hours for the average
response on a per-chemical basis. Under the PRA, burden is defined at 5 CFR 1320.3(b). Send
comments on the Agency’s need for this information, the accuracy of the provided burden estimates and
any suggested methods for minimizing respondent burden to the Regulatory Support Division Director,
U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C.
20460. Include the OMB control number in any correspondence. Do not send the completed form to this
address.
VIII.
FOR FURTHER INFORMATION CONTACT
For technical information contact: Sarah Clark, Data Gathering and Analysis Division (7410M), Office
of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-3977; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave.,
Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected].
IX.
SIGNATURE
Under the authority in TSCA section 4(a)(2), the United States Environmental Protection Agency hereby
issues this Order to take effect on the date of my signature.
Date: [RSB will insert the coded field in the PDF final version.]
Authenticated Digital Signature: [RSB will insert the coded field in the PDF final version.]
Page 19 of 32
Andrew Wheeler,
The EPA Administrator
Enclosures
Page 20 of 32
ENCLOSURE A - EQUIVALENCE DATA
For purposes of this Order, “equivalence data” means “chemical data or biological test data intended to
show that two substances or mixtures are equivalent.” Also, when a chemical substance is “equivalent,”
it means “that a chemical substance is able to represent or substitute for another in a test or series of
tests, and that the data from one substance can be used to make scientific and regulatory decisions
concerning the other substance,” as defined in 40 CFR § 790.3.
If testing under TSCA section 4(a) is required of an equivalent chemical substance, EPA may grant an
exemption from testing to the manufacturer or processor of one substance if the information required
under TSCA section 4(a) is submitted or is being developed on the other, and the manufacturer or
processor submits the following information to support equivalence with its exemption application:
1. The chemical identity of each chemical substance or mixture manufactured or processed by the
applicant for which the exemption is sought. The exact type of identifying data required may be
specified in this Order and may include all characteristics and properties of the applicant’s substance
or mixture, such as boiling point, melting point, chemical analysis (including identification and
amount of impurities), additives, spectral data, and other physical or chemical information that may
be relevant in determining whether the applicant’s substance or mixture is equivalent to the specific
test substance.
2. The basis for the applicant’s belief that the substance or mixture for which the exemption is sought is
equivalent to the test substance or mixture.
3. Any other data which exemption applicants are directed to submit in this Order which may have
bearing on a determination of equivalence. This may include a description of the process by which
each chemical substance or mixture for which an exemption is sought is manufactured or processed
prior to use or distribution in commerce by the applicant.
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ENCLOSURE B - COST SHARING
EPA encourages Order recipients that are responsible for developing the same information on the same
chemical(s) to avoid duplicative testing and share the cost of information development. If a test is
conducted according to a final, approved protocol, it is sufficient that the test is conducted once. Two
ways to avoid duplicative testing are discussed in the Order. They are forming or joining a consortium,
discussed in Unit IV.B. of the Order, or requesting an exemption, discussed in Unit IV.A.3. of the
Order.
Consortia
Persons that form or join a consortium typically execute an agreement with the other members of the
consortium concerning how costs will be shared and how the consortium will operate.
Exemptions
Persons that receive exemptions from testing have an obligation to reimburse the person(s) who perform
the testing and submit the required information that is the basis for the exemption for a portion of the
costs incurred in complying with the requirement to submit such information, and any other person
required to contribute to a portion of such costs. Apportionment of costs between persons receiving
exemptions and the person who actually conducts the test(s) is ideally negotiated between the companies
involved, without EPA participation. EPA has promulgated regulations that explain how EPA views fair
and equitable reimbursement in the context of TSCA section 4(a) test rules. In general, those regulations
(40 CFR § 791.40 through § 791.52) make a presumption that a person’s fair share of the test costs is in
proportion to their share of the total production volume of the test chemical over a specified period of
time that begins one calendar year before the effective date of the rule and continues up to the latest data
available upon resolution of a dispute. While those regulations do not apply to TSCA section 4 Orders,
you may wish to consider them as you decide how to share the costs.
If persons subject to an Order include a person that has been granted an exemption and agreement
cannot be reached on the amount and method of sharing the cost of developing the information, the
person whose information is the basis for the exemption may request that the Administrator order the
person(s) granted the exemption to provide fair and equitable reimbursement after considering all
relevant factors, including the share of the market and the effect on the competitive position of the
person required to provide reimbursement in relation to the person to be reimbursed. See TSCA section
4(c)(3)(A). Upon receipt of such a request, EPA will determine fair and equitable reimbursement and
issue an order accordingly. The Agency may, at its discretion, make use of procedures and standards
applicable to data reimbursement regarding TSCA section 4 rules, contained in 40 CFR § 791.
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ENCLOSURE C - INFORMATION COLLECTED BY THE AGENCY AND
RECORDKEEPING
Requirements for Submission of Test Reports
Each test report submitted to EPA must include the following, as applicable:
1.
A title page including the following information:
2.
The title of the study, including identification of the substance(s) tested and the required test
addressed by the study.
The author(s) of the study.
The date the study was completed.
If the study was performed in a laboratory, the name and address of the laboratory, project
numbers or other identifying codes.
If the report is a commentary on or supplement to another previously submitted report, full
identification of the other report with which it should be associated in review.
For NIOSH Method 1003 and Enclosure F the final test report and underlying and contextual
data must include the following (for further considerations, please refer to Enclosure E):
Facility and Process Parameters:
o Description of process (e.g., equipment/machinery/instruments/handling accessories,
reaction, activities) and relevant associated layout, process, and instrumentation
diagrams.
o Physical state(s) (solid/liquid/emulsion/particulate/gas) and flow rate of unit operation
and/or process train (e.g., kg/hour or m3/hour).
o Weight fraction(s) of trans-1,2-dichloroethylene in the process(es).
o Frequency of operation of individual processes (e.g., days/year; days/month and months
per year; or days/week and weeks/year).
o Individual process duration (e.g., hour/day).
Sampling and Monitoring:
o Purpose of sampling (e.g., compliance, worst-case, ceiling, short-term, peak).
o Sample type: (e.g., area/personal/dermal/ field blank, replicates, fortified sample).
o Sampling and monitoring methods used (e.g., EPA/ASTM/NIOSH/equivalent method
and number).
o Sampling device(s) used to collect samples.
o Sample ID#.
o Dates of sampling (mm/dd/year).
o Duration and frequency of sample(s) collected or sampling start and end times.
o Locations of sampling devices (e.g., distance from the process/release source and height).
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o Analytical method(s) used (e.g., EPA/ASTM/NIOSH/equivalent method and number).
o A description of the data validation and data quality procedures performed to ensure
sample integrity during transportation, reproducibility of sample results, and quality
assurance/quality control measures implemented (e.g., field blanks, replicates, duplicates,
spiked samples), sampling and analytical reproducibility, extraction efficiency, accuracy,
precision, and reliable quantitation limit of measurements.
o Method detection limit, limit of quantification and limit of detection of trans-1,2dichloroethylene (e.g., ug/L, ug/m3 or ug/kg).
o Data acceptance criteria (for each field sampling and analytical operations).
o Results, including units.
o Chain of custody procedures used.
o Observer notes (e.g., deviations from sampling and analytical plan, anomaly and other
field observations).
Information Regarding the Representative Sample Population:
o Worker (which includes ONU) demographics (age, sex, and length of service) submitted
as data points with no personal identifying information.
For age, place each worker within one of the following age ranges: 16-20 years
old, 21-30 years old, 31-40 years old, 41-50 years old, 51-60 years old, 61-70
years old, 70+ years old.
o Worker job title (e.g., material handler, loader; however, do not include names of
individual workers) and description of that employee’s activities.
o Duration of Work/Activity (e.g., hour/shift of worker).
o Shift duration (e.g., hour/day); note, samples should generally be collected to cover the
entire work shift; if partial shift, indicate length of time.
o Concentration (µg/L; µg/m3; or µg/kg) of trans-1,2-dichloroethylene at the source of the
worker activity and Area/Worker Location.
Ventilation, Engineering Controls, and Personal Protective Equipment:
o Are existing administrative and engineering controls in place? (yes/no).
o If so, describe for each engineering control(s) the type of control used (e.g., annular
exhaust for capturing vapors during drum filling).
o Describe the room/ work area volume (m3).
o Describe the type of room/work area ventilation (positive/ negative pressure, indoor,
outdoor).
o Describe the air changes per hour in the Work Area.
o Describe the ventilation rate (e.g., m3/hour or cm3/second).
o Type of Personal Protective Equipment (PPE), including material of construction of
gloves for dermal; types of cartridges for respirators and other specification as applicable,
and duration of PPE use during normal operations.
o Type and duration of PPE usage during emergency (e.g., accidental release, spillage).
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3. If sections of the report are claimed to be CBI, the report must be accompanied by a signed and
dated document containing the appropriate statement(s) regarding confidentiality in Unit IV.B.
of the Order and a sanitized version of the report only removing the specific CBI content must
be submitted.
4. A statement of compliance with respect to GLP standards as set forth in 40 CFR § 792 and
applicable to this Order.
Submission Instructions
The Initial Response, proposed and final study plans, final test reports with underlying data, existing
studies, any testing related requests, and all related correspondence must be submitted electronically to
EPA as follows:
1. Submit to EPA’s Central Data Exchange (CDX) system. CDX is the point of entry on the
Environmental Information Exchange Network (Exchange Network) for submissions to the
Agency.
2. The URL for the CDX website is https://cdx.epa.gov/ which takes you to the CDX homepage.
3. On the homepage you may select “Log in” or, if you haven’t already registered, select “Register
with CDX.”
4. Once you have logged on to CDX, follow the instructions for submitting TSCA section 4 Order
information. To access the instructions, select “Report electronically” on EPA Internet homepage
at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronic-reportingrequirements-certain-information#data.
5. The CDX Help Desk is available for data submission technical support between the hours of
8:00 am and 6:00 pm (EST) at 1-888-890-1995 or [email protected]. The CDX Help Desk
can also be reached at 970-494-5500 for international callers.
Recordkeeping
Retain copies of all information documenting your compliance with this Order for ten years. This
includes your Initial Response and other documents and correspondence submitted to comply with this
Order, such as test protocols, testing related requests, final test reports with their underlying data, and
any penalties remitted.
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ENCLOSURE D - ORDER RECIPIENT SELECTION RATIONALE
The manufacturers and processors of the chemical subject to this Order were determined in the
following manner:
1. Manufacturers: All companies included in the final list of manufacturers subject to fee
payments for trans-1,2-dichloroethylene developed under the “Fees for Administration of Toxic
Substances Control Act” rule in 2020 are subject to this order. This final list was developed
using the following methodology to capture manufacturers of the subject chemical:
EPA used a diverse pool of data sources to compile a preliminary list of all manufacturers
(including importers) of the High Priority Substances based on information submitted or
available to the Agency within the past 5 years. These data sources included information
submitted to EPA (e.g., information submitted under TSCA sections 5(a), 8(a) (including
Chemical Data Reporting (CDR)), 8(b), and to the Toxics Release Inventory (TRI)) along with
publicly available information (e.g., Panjiva (a provider of data on trade that can be used to help
identify customers of certain products)) or information submitted to other agencies to which EPA
has access (e.g., U.S. Customs and Border Patrol data). Once compiled, this preliminary list was
published to the Federal Register for a public comment period of no less than 30 days. This
public comment period allowed stakeholders the opportunity to make corrections to the list and
provided the platform for a legally required and enforceable self-identification and certification
process for manufacturers on the preliminary list (or absent from the preliminary list despite
being manufacturers of the chemical in question). After closure of the comment period and
further EPA review, the Agency published the final list of manufactures of the subject chemical
at https://www.epa.gov/tsca-fees/final-list-fee-payers-next-20-risk-evaluations. For more detail
on the methods used under “Fees for Administration of Toxic Substances Control Act,” see the
complete rule text in docket EPA-HQ-OPPT-2016-0401-0072.
2. Processors: All companies who reported as “Processors” for this chemical to the 2019 Toxics
Release Inventory before 09/01/2020 are subject to this Order unless they reported that their only
processing activity occurs under the “As an Impurity” category. A snapshot of TRI, which is a
continuously changing database that does not have a cutoff date for reporting, was taken on
09/01/2020 to determine the Order recipients for the subject chemical. Because process
impurities are not included in the scope of the TSCA section 6 risk evaluation for the subject
chemical, EPA does not need data on these activities and will not be collecting information from
processing companies whose only handling of the subject chemical is as an impurity. Although
EPA recognizes that there are processors who do not report to TRI, this database was used to
identify processors for the purposes of this order because it is the Agency’s most comprehensive
source to establish a well-verified list of processing companies.
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ENCLOSURE E - RESOURCE FOR REPORTING OCCUPATIONAL EXPOSURE DATA
In Enclosure E, EPA is providing a sample matrix of monitoring parameters to collect monitoring data and reporting the results. The table
could be modified as needed for a given chemical, industry sector and condition of use. Additional information may be required for casespecific conditions.
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ENCLOSURE F - DERMAL HAND WIPE SAMPLING – SOLVENTS
1.0.
Purpose and Scope
1.1.
This general protocol describes procedures for collecting dermal exposure samples from the
hand surfaces of workers and occupational non-users (ONU)s. The protocol is intended to
measure exposure to workers as they perform their normal work functions.
1.2.
The monitoring procedures shall minimize cross-contamination between samples to the extent
practicable.
2.0.
EQUIPMENT REQUIRED
The following materials are required for collecting dermal hand samples:
a.
Two 3-inch x 3-inch or appropriate size activated charcoal cloth pads
b.
Disposable gloves
c.
120 mL amber glass jar with teflon-coated or other tightly sealed lids
d.
Parafilm or equivalent to seal the glass jar
e.
Cooler with dry ice or a freezer
f.
Paper for hand tracing (or use the back of the sample collection form)
g.
Large Ziplock® bags or equivalent quality sealable plastic bags
3.0.
ABSORPTIVE CAPACITY AND SAMPLE STABILITY DETERMINATION
3.1.
Determine the absorptive capacity of the selected activated charcoal cloths in the lab by
placing the activated charcoal cloth pads in a beaker placed in a tightly closed jar
containing 99.99 percent of the test chemical at room temperature. Remove three pads from
the jar at 24, 48, 72 and 96 h and analyze them using gas chromatograph coupled with a
flame ionization detector (GC-FID) for the test chemical. Determine the maximum
absorptive capacity of the samples taken at all sampling intervals in comparison with
anticipated dermal exposure in the field.
3.2.
Determine the sample stability by placing two fortified (spiked) activated charcoal cloth
pads in a 120mL amber glass jar tightly sealed with parafilm in a freezer.
3.3.
Perform laboratory analysis to determine the amount retained on the activated charcoal
cloth pads for 7 or more consecutive days to determine the length of time for which the
concentration of the test chemical is stable on the activated charcoal cloth pads.
4.0.
SAMPLING PROCEDURE
4.1.
The field personnel collecting samples will wear clean, disposable gloves while collecting
the dermal wipe samples.
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4.2.
Collect dermal hand wipe samples pre-, mid-, and post-shift from the hands of workers and
ONUs to be monitored.
4.3.
Place two sterile activated charcoal cloth pads (of predetermined size, based on absorptive
capacity testing) in 120 mL amber glass jars. The jars are tightly sealed and stored at
approximately 5o C for up to 7 days (or as determined based on the sample stability
determination), until they were used for collection. Do not use jars that are older than a
week (or as determined in the sample stability determination) for sample collection.
4.4.
If the worker is wearing additional Personal Protective Equipment (PPE), such as gloves,
goggles or a respirator, the worker will remove all PPE before having the hand wipes
collected and before washing hands.
4.5.
Samples shall be collected in an area outside of the work area (e.g., at company
headquarters, in a construction trailer, etc.). During sample collection and immediately
after glove removal, if applicable, participants are instructed to grab one of the activated
charcoal cloth pads and wipe both sides of their bare hands (the area from the bend of the
wrist to the fingertips) for 30 s. Then they are instructed to grab the other wipe and repeat
the process. Both activated charcoal cloth pads are placed into the same jar, sealed, and
stored at refrigerated temperatures until analyzed. Once both activated charcoal pads are
placed back into the jar, it is sealed with parafilm or equivalent, and stored at refrigerated
temperatures until analyzed. At the mid- and post-shift hand wipe collection, the process is
repeated. Workers are asked how many times they washed their hands since pre-shift; the
information is recorded on the sample collection form. Note, workers are not to wash their
hands prior to dermal wipe sampling. Trace the participant’s right hand on the back of the
sample collection form.
4.6.
The following information shall be obtained and recorded on the sample collection sheet
for each participant:
a.
How many times did the participant wash their hands?
b.
What types of gloves were worn?
c.
If gloves were worn for what duration and for which tasks?
4.7.
Field fortification (spiked) and field blank samples are collected to provide a
“recovery” value which will quantify stability of the test chemical during sample
collection, storage in the field, shipment to the laboratory, and storage in the
laboratory freezer. At least one field blank is collected for each hand wipe samples
collected. Field blank samples are taken by soaking a gauze pad in isopropanol and
placing it directly into a glass jar. Replicate samples are collected in the field to
detect variation between samples.
4.8.
Similar quality control procedures are followed in the laboratory, including control
and fortification samples which are designed to detect background residues, monitor
the performance of the method, and detect matrix or reagent interferences which
may be present.
5.0.
FIELD STORAGE
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Place samples collected during the study in the field in a cooler with dry ice or portable freezer until
processed and placed into frozen storage for shipping at the end of the monitoring day (or as soon as
practical).
6.0.
SAMPLE EXTRACTION AND PREPARATION
6.1.
Left and right hands are sampled separately but extracted and analyzed together, providing
one measurement per participant.
6.2.
Samples are extracted11 with spectrographic grade carbon disulfide (CS2) by desorbing the
sorbed analytes directly into a glass container following the NIOSH method 1501. The
extract is filtered on cellulose based filter to remove carbon residues and injected for the GCFID analysis. The blank is prepared by using activated charcoal without any treatment.
6.3.
Limits of detection and quantification are determined according to NIOSH guidance 95117 (Kennedy et al., 1995). One procedural blank and at least one field blank are run with
each batch of samples (ten samples). One blank spike and at least two blanks are run with
each batch of ten samples. The blank spike and blank spike duplicate must be extracted and
analyzed within holding time. Each spiked replicate may be adjusted for background
chemical contamination in consideration with the matrix blank.
7.0.
INTERFERENCES
A potential interference in the applicability of this method could be that the pads could absorb organic
vapors through passive diffusion in addition to dermal exposure to droplets and aerosols. Appropriate
corrections for ambient levels of the organic compounds may be required. The wipe pads have been found
to contain high background concentrations of potential interferents (EPA, 2007). In such instances where
there is an interference, the wipes must be pre-cleaned, removing the potential interferent, before any
sampling can occur (EPA, 2007).
Alternatively, thermal desorption, using a heat source to increase the volatility of the analytes, could be used to recover
solvents from activated charcoal pad. This technique requires no solvent thus the adsorbed chemicals are not diluted, but
thermal desorption could have wide variations and depends on the volatility of the solvent chemicals, with decreasing
recovery as boiling-point of chemical of interest increases.
11
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| File Type | application/pdf |
| File Title | Microsoft Word - 19901_01AH_Test_Order_Doc_(trans-12-DCE).docx |
| Author | AHofmann |
| File Modified | 2021-01-08 |
| File Created | 2021-01-07 |