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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 (30 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 review the presentation
available on the TSCA Section 4 Test Order webpage (https://www.epa.gov/assessing-and-managingchemicals-under-tsca/tsca-section-4-test-orders), which gives an overview on Orders issued pursuant to
TSCA section 4.
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 Substance Subject to this Order:
Chemical Name: 1,2-Dichloropropane
Chemical Abstracts Service Registry Number (CASRN): 78-87-5
Docket Identification (ID) Number: EPA-HQ-OPPT-2018-0428 1
Testing Required by this Order:
1. Environmental Hazard
•
Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)
•
Avian Dietary Toxicity Test
•
Avian Reproduction Test
2. Consumer Exposure
•
Emission Rate From Use of Cleaning and Furnishing Care Products, Such as Stone
Polish/Sealer Containing 1,2-Dichloropropane in the Form of Wax and/or Paste, Liquid,
and Spray Through Chamber Testing
Recipients of this Order:
[Insert Company Name(s)]
Dear Recipient:
This Order requires you and the other named manufacturer(s) and/or processor(s) of 1,2dichloropropane (CASRN 78-87-5) to develop and submit certain information for 1,2-dichloropropane,
or otherwise respond to the U.S. Environmental Protection Agency (referred to herein as “the 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 TSCA section
16, 15 U.S.C. § 2615.
This Order is effective 5 calendar days after its date of signature by the EPA. The timeframes and
options for responding are described in Unit IV (Response Options). Please note that the email
1
To access the docket, go to https://www.regulations.gov.
Internet Address (URL) • http://www.epa.gov
transmitting this Order to you will provide the calendar date for the response deadlines as defined in
Unit III (Deadlines for Responding to this Order). 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
II. Statement of Need .............................................................................................................................. 5
III. Deadlines for Responding to this Order.......................................................................................... 10
IV. Responding to this Order ................................................................................................................ 11
V. Overview of Testing Required by this Order ................................................................................... 15
VI. Requirements of Response Option 1: Develop the Information Required by this Order ............... 16
VII. Fees for Submitting Information ................................................................................................... 20
VIII. Instructions if You Choose to Participate in a Consortium ......................................................... 20
IX. Confidentiality ................................................................................................................................ 21
X. Consequences of Failure to Comply with this Order ....................................................................... 22
XI. References....................................................................................................................................... 22
XII. Paperwork Reduction Act Notice .................................................................................................. 25
XIII. For Further Information Contact ...................................................Error! Bookmark not defined.
XIV. Signature .......................................................................................Error! Bookmark not defined.
Appendix A - Equivalence Data ............................................................................................................... 25
Appendix B - Cost Sharing ....................................................................................................................... 28
Appendix C - How to Access the CDX Application and Recordkeeping RequirementsError! Bookmark
not defined.
Appendix D - Order Recipient Selection ...................................................Error! Bookmark not defined.
Appendix E - Specific Requirements And Guidance For This Order ...................................................... 29
I. PURPOSE AND AUTHORITY
A. OVERVIEW
This Order is being issued under the authority of the Toxic Substances Control Act (TSCA), 15 U.S.C. §
2601 et seq. TSCA section 4 authorizes the EPA to require the development of necessary information
related to chemical substances and mixtures.
This Order requires the identified recipients to develop and submit new information on 1,2dichloropropane (CASRN 78-87-5) that is necessary for the EPA to perform a risk evaluation under
TSCA section 6(b).
Information on testing requirements is provided in Appendix E. The EPA encourages the formation of
industry consortia to jointly conduct testing between the recipients of this Order. See Unit VIII for more
information on this topic.
2
The Order provides four response options, listed below. More information on each of these options is
provided in Unit IV. Timeframes for these options is provided in Unit III. Note that the deadline to
identify as a manufacturer, processor, or both is 30 calendar days of the effective date of this Order. This
step is necessary for purposes of this Order to ensure that your company can appropriately access the
CDX application used for responding to section 4 orders.
Option 1: Develop the Information
Use this option to develop information in response to all of the requirements of this Order that
apply to you, or use this option in conjunction with other response options identified in this
section as appropriate.
Manufacturers who are required to test a chemical substance or mixture pursuant to a TSCA
section 4 order are also required to pay a fee (see Unit VII).
Option 2: Submit Existing Information
Use this option to submit an existing study and/or other scientifically relevant information that
you believe the EPA has not considered, along with supporting rationale that explains how the
submittal(s) meets part or all of the information described as necessary in Unit II. If the Agency
determines that the submitted information satisfies one or more data needs identified by this
Order, the Agency will extinguish any associated test requirement(s).
Option 3: Request an Exemption
Use this option to request an exemption from a testing requirement of this Order. The EPA will
grant an exemption if:
1. Information on the subject chemical or 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 (including this 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 (including this Order), or consent agreement.
Option 4: Claim that You Are Not Subject to this Order
Use this option to claim that you are not subject to this Order. You may claim that you are not
subject to this Order if all of the following are true:
1. You do not currently manufacture or process the chemical(s) identified by this Order;
2. You do not intend to manufacture or process the chemical(s) within the period of testing
provided by this Order; and
3. You have not manufactured or processed the chemical(s) at any time during the five years
preceding the date of this Order.
You must provide an explanation of the basis for your claim, along with appropriate supporting
information to substantiate that claim.
3
B. TERMINOLOGY USED IN THIS ORDER
The term “manufacture” means to import into the customs territory of the United States, to produce, or
to manufacture. 15 U.S.C. § 2602(9). Import also includes importing the chemical as an impurity in an
article.
The term “process” means the preparation of a chemical substance or mixture, after its manufacture, for
distribution in commerce—(A) in the same form or physical state as, or in a different form or physical
state from, that in which it was received by the person so preparing such substance or mixture, or (B) as
part of an article containing the chemical substance or mixture. 15 U.S.C. § 2602(13).
The term “chemical” or “substance” means a chemical substance or mixture.
C. PERSONS SUBJECT TO THIS ORDER
1. Persons Identified
An order issued under section 4(a) of TSCA may require the development of information by any person
who manufactures or processes, or intends to manufacture or process, a chemical substance or mixture
subject to the order. The recipients of this Order are listed at the top of the Order.
For purposes of this Order, a recipient identified by this Order is subject to the Order if it has
manufactured or processed the chemical at any time during the five years preceding the date of this
Order. If a recipient identified by this Order has not manufactured or processed the chemical during the
prior five years, the recipient is nevertheless subject to the Order if they intend to manufacture or
process the chemical within the period of testing provided by this Order.
A person who contracts with a producing manufacturer to manufacture or produce a chemical substance
is also a manufacturer if (1) the producing manufacturer manufactures or produces the substance
exclusively for that person, and (2) that person specifies the identity of the substance and controls the
total amount produced and the basic technology for the plant process.
A recipient who is an importer of record of a chemical substance identified by this Order is responsible
for the testing requirements of this Order, even if the recipient does not store, handle, use, or otherwise
directly deal with the chemical.
The means by which the EPA identified each recipient subject to this Order does not govern whether a
recipient is subject to this Order. Ultimately, any recipient that meets the criteria discussed in this
section is subject to this Order, regardless of the basis on which the Agency identified the recipient.
2. Corporate Structure of Recipients: Changes of Ownership
The EPA has attempted to identify the highest-level U.S. corporate entity for purposes of issuing this
Order. The highest-level U.S. corporate entity is ultimately responsible for satisfying the obligations of
this Order, although the highest-level U.S. corporate entity may delegate its responsibilities under this
Order to a U.S. subsidiary. Where the corporate entity named in this Order is not the highest-level U.S.
corporate entity, the Agency nonetheless considers notification of the company named in this Order to
constitute notification of the highest-level U.S. corporate entity and holds the highest-level U.S.
corporate entity ultimately responsible for satisfying the obligations of this Order.
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Should you wish to modify the name of the recipient or identify another U.S. corporate entity in the
corporate structure as the point of contact in place of the recipient named in this Order, you must submit
a request to the EPA. Submit your request, justification for the change, and contact information for the
representatives of the newly named entity to [email protected]. A representative from the
Agency will contact you and any other representatives regarding this request.
In the event of mergers, acquisitions, or other transactions that create a corporate successor in interest
(subsequent to the manufacturing or processing that triggered the reporting obligation, and either before
or after receipt of this Order), that successor in interest is responsible for satisfying the obligations of
this Order. The successor in interest must notify the EPA of its identity within 14 days following the
transaction.
D. PREVIOUSLY ISSUED ORDERS
The EPA previously issued a test order for 1,2-dichloropropane, effective January 19, 2021, to meet
other data needs. See https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section4a2-test-order-12-dichloropropane 2.
Since issuing that test order, the EPA’s continuing review of the reasonably available information has
identified additional information needed to inform the associated risk evaluation. Accordingly, the
Agency is issuing this additional Order for 1,2-dichloropropane. See the Statement of Need for further
details. This Order does not alter the requirements of any previous test orders.
II. STATEMENT OF NEED
The basis for requiring the development of new information by this Order is described in this unit and in
Appendix E. This statement of need, as required by TSCA section 4(a)(3), 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) (if applicable) the basis for the
Agency’s decision to require testing of vertebrate animals. Appendix E (Testing Requirements of This
Order) indicates which tests apply specifically to manufacturers and/or processors subject to this Order.
A. THE NEED FOR THE NEW INFORMATION
This section and Appendix E explain what new information is being required in this Order and why
such information is needed for the risk evaluation of 1,2-dichloropropane under TSCA section 6(b).
The EPA has identified the following information in this section as necessary to conduct a risk
evaluation to determine whether 1,2-dichloropropane presents an unreasonable risk of injury to health or
the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk
to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the
Administrator, under the conditions of use (COU).
The next unit will outline how the EPA came to determine these new information needs. Note that
additional details for these testing requirements are provided in Unit V and Appendix E.
2
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-4a2-test-order-12-dichloropropane
5
1. Environmental Hazard
Information on hazards to aquatic and terrestrial organisms is needed to conduct a risk
evaluation. The relevant environmental hazard data needs that this Order seeks to address for
1,2-dichloropropane, are as follows:
•
Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)
•
Avian Dietary Toxicity Test
•
Avian Reproduction Test
2. Consumer Exposure
Information on exposures from the use of certain consumer products is needed to conduct a risk
evaluation. The relevant consumer products exposure data needs that this Order seeks to address
for 1,2-dichloropropane, as described below, are as follows:
•
Emission Rate From Use of Cleaning and Furnishing Care Products, Such as Stone
Polish/Sealer Containing 1,2-Dichloropropane in the Form of Wax and/or Paste, Liquid,
and Spray Through Chamber Testing
B. HOW INFORMATION REASONABLY AVAILABLE TO THE ADMINISTRATOR WAS USED TO INFORM
THE DECISION TO REQUIRE NEW INFORMATION
This section details the “Scoping and Conceptual Models” and “Systematic Review of Reasonably
Available Existing Information” processes used by the EPA to identify, respectively, what information
is reasonably available to integrate into the risk evaluation for the conditions of use of 1,2dichloropropane and ascertain, via a “Discipline-Specific Approach for Identifying Data Needs” what
needed information is not reasonably available in existing literature (i.e., what testing to require).
1. Scoping and Conceptual Models
The Final Scope of the Risk Evaluation for 1,2-Dichloropropane
(https://www.epa.gov/sites/default/files/2020-09/documents/casrn_78-87-5_12dichloropropane_finalscope.pdf 3) (hereinafter “Final Scope”) includes the hazards, exposures,
conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to consider
in the TSCA section 6(b) risk evaluation for 1,2-dichloropropane. The Agency has used the scope
document and the conceptual models therein for workers and occupational non-users (ONUs),
consumers and bystanders, general population, and environmental releases as a starting point for
identifying information needs under this Order. The conceptual models visually represent the human and
environmental exposures (pathways and routes), receptors, and hazards associated with the conditions of
use of 1,2-dichloropropane. For each exposure (pathway and route), receptor, and hazard that is visually
represented, the EPA has identified the information needed to conduct a risk evaluation for this
chemical.
In addition, since publication of the Final Scope, the EPA has reconsidered the policy decision to
exclude from the scope of TSCA section 6(b) risk evaluations certain exposure pathways and risks
falling under the jurisdiction of other EPA-administered statutes or regulatory programs. Based on that
reconsideration, the Agency now also intends to consider in the TSCA section 6(b) risk evaluation for
3
https://www.epa.gov/sites/default/files/2020-09/documents/casrn_78-87-5_12-dichloropropane_finalscope.pdf
6
1,2-dichloropropane all of the exposure pathways portrayed in Figure 2-15 (Conceptual Model for
Environmental Releases and Wastes: Environmental and General Population Exposures and Hazards
(Regulatory Overlay)) of the Final Scope, and has identified the information needed for that assessment.
2. Systematic Review of Reasonably Available Existing Information
The systematic review process began with searching peer-reviewed literature databases (e.g., Agricola,
PubMed, Science Direct, ECOTOX Knowledgebase) for studies using 1,2-dichloropropane, synonyms,
and trade names. The EPA also conducted a search of gray literature (e.g., technical reports, reference
books, dissertations, and other information not found in standard, peer-reviewed literature databases), as
well as review of public comments posted to the docket for this chemical substance during the
prioritization process and following publication of the draft scope document, relevant data and
information 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 and consumer exposure (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)).
3. Discipline-Specific Approach for Identifying Data Needs
a. Environmental Hazard
The EPA defined the pathways and routes of exposure, receptors, and hazards for environmental
releases and wastes that are expected to be evaluated in the Final Scope (Figure 2-15 pg. 46). As noted
above, since publication of the Final Scope document, the Agency has reconsidered the policy decision
to exclude from the scope of TSCA section 6(b) risk evaluations certain exposure pathways and risks
falling under the jurisdiction of other EPA-administered statutes or regulatory programs. The Agency
intends to consider all aquatic and terrestrial exposure pathways in the TSCA section 6(b) risk
evaluation for 1,2-dichloropropane, and has identified the information needed for that assessment.
As determined in the Final Scope, the manufacturing, processing, distribution, use and disposal of 1,2dichloropropane can result in releases to the environment and exposure to aquatic and terrestrial
organisms. The EPA expects to assess environmental hazards and risks to both aquatic and terrestrial
plants, invertebrates, and vertebrates and therefore requires hazard data for each of these assessment
endpoints. The Agency 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).
Identification of the reasonably available information for 1,2-dichloropropane included consideration of
existing data for the parent chemical and analogous chemicals for aquatic and terrestrial exposure
pathways. The EPA identified 27 analogues to 1,2-dichloropropane using the EPA’s Analog
Identification Methodology (AIM) software (see Unit II.B, Environmental Hazard – Analogues
Table). The Agency identified existing measured environmental hazard data for aquatic and terrestrial
species for 1,2-dichloropropane and the identified analogues from the EPA’s ECOTOX Knowledgebase
(ECOTOX) and information submitted under TSCA, (e.g., under Sections 4 and 8e), FIFRA, and the
Endocrine Disruptor Screening Program (EDSP).
7
Pursuant to this Order, the EPA is requiring data be submitted to facilitate evaluation of risk to terrestrial
organisms. An order requesting testing to fill the aquatic data gaps identified for 1,2-dichloropropane
was issued previously (see Unit XI, References). As shown in the table below, terrestrial environmental
hazard data were identified for 1,2-dichloropropane and five of the twenty-seven identified analogues.
These data covered exposures of 1,2-dichloropropane to terrestrial vegetation, acute exposures to soil
invertebrates and mammals, and chronic exposures to mammals. No acute toxicity data for birds, or
chronic toxicity data for soil invertebrates or birds were identified.
Table 1. Terrestrial Environmental Hazard – Analogues
Chemical Name
1,2-Dichloropropane
Environmental Hazard Data Availability for 1,2-Dichloropropane
Acute Exposure
Chronic Exposure
CASRN
Vegetation
Soil
Soil
Mammal Bird
Mammal Bird
Invertebrate
Invertebrate
78-87-5
X
X
X
X
Analogues for 1,2-Dichloropropane
1,2-Dichloropropane & 1,38003-19-8
Dichloropropene
1,1-Dichloropropane
78-99-9
X
2,2-Dichloropropane
594-20-7
Chlorinated paraffin waxes
63449-39-8
X
and hydrocarbon waxes
Propane, 1-chloro-2-methyl513-36-0
2-Chlorobutane
78-86-4
Dichloropropane
26638-19-7
Butane, 1,2dichloro
616-21-7
Butane, Pentachloro31391-27-2
1,2,3-Trichlorobutane
18338-40-4
2,5-Dichlorohexane
13275-18-8
Heptane, 1-chloro-5-methyl2350-24-5
1,1-Dichlorobutane
541-33-3
Alkanes, C6-18, chloro
68920-70-7
3-(Chloromethyl) Heptane
123-04-6
Dodecane, 2-chloro2350-11-0
Chlorinated paraffins: C12,
108171-26-2
60% chlorine
Chlorinated paraffins: C23,
108171-27-3
43% chlorine
Hydrocarbons, C2-6, chloro 68476-48-2
Hydrocarbons, C1-6, chloro 68606-33-7
Chlorowax 500C
51990-12-6
Chloroalkanes C10-13
85535-84-8
Octane, 1,2-dichloro21948-46-9
X
Paroil 1048
85535-85-9
Pentane, 2,3-dichloro600-11-3
Alkanes, C18 - 28, chloro
85535-86-0
Paraffin oils, chloro85422-92-0
X signifies data were identified and “-” signifies a gap, where no data were identified
8
-
-
-
X
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
X
-
b. Consumer Exposure
As determined in the Final Scope, the use of consumer products containing 1,2-dichloropropane
can result in exposures to users and bystanders. The EPA expects to assess risks to consumers
and bystanders and therefore requires data to inform the estimation of inhalation, dermal, and/or
oral exposures to chemicals contained in consumer products and/or articles.
Evaluation of reasonably available information for 1,2-dichloropropane included consideration
of existing data that has gone through initial stages of the systematic review process (full-text
screening) and was tagged for this chemical for relevant consumer exposure pathways and
conditions of use. A data gap analysis of the systematic review data source pool was undertaken
to support this data request.
Emission rate data were identified for newly produced household furniture, such as desk chairs,
bedside tables, dining tables, sofas, and cabinets; however, emission rate data relevant to the
referenced consumer condition of use targeted for testing (i.e., cleaning and furnishing care
products, such as wax, liquid, and spray stone polish/sealer) for 1,2-dichloropropane were not
found. Therefore, emission rate is needed to estimate consumer and bystander inhalation
exposure to cleaning and furnishing care products, such as wax, liquid, paste, and spray stone
polish/sealer would enable the EPA to discern potential exposures.
C. WHY ISSUANCE OF THIS ORDER IS WARRANTED INSTEAD OF PROMULGATING A RULE OR
ENTERING INTO A CONSENT AGREEMENT
The EPA is using its order authority under TSCA section 4(a)(2) to inform the risk evaluation for 1,2dichloropropane under TSCA section 6(b) in accordance with the requirements and timeframes for
conducting the risk evaluation. Use of this TSCA section 4(a)(2) authority will allow the Agency to
target known manufacturer and processor recipients to obtain the needed information more quickly than
if the EPA were to issue a TSCA section 4 rulemaking or consent agreement.
D. THE EPA DETERMINED THAT VERTEBRATE TESTING IS NEEDED IN THIS ORDER
The EPA has determined that vertebrate testing is needed to assess the particular exposure pathways and
receptors discussed in this Order. Reasonably available data, computational toxicology, or highthroughput screening methods and prediction models are not available and/or cannot be used to address
the avian reproduction testing required by this Order (see below for details). The analysis for
determining data needs described in Unit II.B included use of acceptable new approach methodologies
(NAMs), specifically the EPA computational toxicology and informatics tools such as AIM, to identify
analogues with existing information that could potentially fill data needs. A list of the testing on
vertebrates required by this Order as well as further information on the EPA review process that led to
the inclusion of such testing requirements can be found in Unit II.B and Appendix E, as well as below.
1. Environmental Hazard: Avian Dietary Toxicity Test
No acute avian toxicity data were identified for the parent or identified analogues for any apical
or non-apical endpoints. No approved or readily available new approach methodologies (NAMS)
were identified that could be used to inform the data gap for avian toxicity in the absence of test
data. Without toxicity data, EPA is unable to determine if acute exposures to 1,2dichloropropane pose a risk to terrestrial vertebrates. Office of Pesticide Programs recently
released a guidance that describes instances where sub-acute dietary testing in birds may be
9
waived (U.S. EPA, 2020). This waiver specifically outlines instances where the animal testing
burden can be reduced by requesting acute oral and chronic dietary testing in birds and waiving
the FIFRA requirement for acute oral , sub-acute dietary testing , and chronic dietary toxicity
testing. EPA has worked to ensure that the animal testing burden under TSCA is reduced by
utilizing all available ecotoxicity data and tailoring data needs to the specific properties of each
chemical. EPA has determined that the sub-acute dietary testing is more relevant than the acute
oral toxicity test based on the expected dietary exposure route for this chemical. As a result, EPA
is requesting sub-acute dietary toxicity test be submitted, rather than both acute oral and subacute
dietary testing, and that it is conducted with bobwhite quail, rather than two test species. The
U.S. Geological Survey (USGS) National Water Quality Monitoring Council (NWQMC) has
also identified 1,2-dichloropropane in media to which terrestrial organisms could be exposed.
This includes ground water, sediment, soil, surface water and ecological tissue (e.g., fish tissue
concentrations) (USGS, 1991). Existing assessments reported that 1,2-dichloropropane appears
to be stable and present in the air, soil, surface water, and groundwater (RIVM, 2007; OECD,
2006; CalEPA, 1999).
2. Environmental Hazard: Avian Reproduction Test
No chronic avian toxicity data were identified for the parent or identified analogues for any
apical or non-apical endpoints. No approved or readily available new approach methodologies
(NAMS) were identified that could be used to inform the data gap for avian toxicity in the
absence of test data. Without toxicity data, EPA is unable to determine if chronic exposures to
1,2-dichloropropane pose a risk to terrestrial vertebrates. The U.S. Geological Survey (USGS)
National Water Quality Monitoring Council (NWQMC) has also identified 1,2-dichloropropane
in ground water, sediment, soil, surface water and ecological tissue (e.g., fish tissue
concentrations) to which terrestrial organisms could be exposed (USGS, 1991). Existing
assessments reported that 1,2-dichloropropane appears to be stable and present in the air, soil,
surface water, and groundwater (RIVM, 2007; OECD, 2006; CalEPA, 1999).
III. DEADLINES FOR RESPONDING TO THIS ORDER
This section describes the deadlines for this Order and possible modifications to such deadlines.
A. DEADLINES FOR RESPONSES TO THIS ORDER
The table below provides the deadlines for this Order. Deadlines that fall on a weekend or holiday will
remain and will not be extended to the next weekday. Descriptions of these response options and the
required process associated with each option is provided in Unit IV.
Table 2. Deadlines for Responses, Study Plans, and Test Reports
Order Requirement
Recipient’s Deadline (Days after the
effective date of the Order)
30
EPA Response
Deadline*
n/a
•
Identify as a Manufacturer, Processor or Both
•
Submit Request to Modify Corporate Identity
Identified
30
n/a
•
Choose to Submit Existing Data (Option 2)
30
45
•
Claim that You Are Not Subject to this Order
(Option 4)
45
60
10
•
Choose to Develop the Information - On Own or as
Part of a Consortium (Option 1)
65
n/a
•
Request an Exemption (Option 3)
65
80
Submit Draft Study Plan
80
95
•
110
125
Deadline varies per Test Requirement (See Unit V and
• Submit Final Test Report
Appendix E)
*See Unit III.B for potential automatic extensions associated with the EPA responses. Deadlines for submitting final test
reports for each required test are provided in Appendix E.
•
Submit Final Study Plan
B. AUTOMATIC EXTENSIONS TO DEADLINES
The EPA will automatically extend deadlines should the Agency fail to meet any EPA response
deadline set forth in Unit III.A. Specifically, deadlines will be automatically extended should the
Agency fail to respond within 15 calendar days of the deadline for a response option if the response was
submitted in the CDX application prior to the deadline provided. For each day exceeding the 15-day
period following the associated deadline, the EPA will extend subsequent deadlines by one day.
Should a recipient amend their response, at any time, the EPA will not extend any associated or
subsequent deadlines. Therefore, the Agency recommends that recipients submit their amendments or
extension requests as early as practicable to ensure adequate time to perform any required testing given
that the Agency will not automatically extend deadlines for any such amendments to responses.
The EPA will not automatically extend a deadline for a response should the recipient submit its
response after the deadline for the given response option. Additionally, the EPA will not
automatically extend a deadline for a response should the Agency respond within 15 days of the
deadline for a given response option that was submitted on or before the deadline for that response
option.
Other than potential automatic extensions to deadlines described here, Unit III.C provides the process
for requesting an extension to a deadline.
C. REQUESTING AN EXTENSION TO A DEADLINE FOR RESPONDING TO THIS ORDER
If you believe you cannot submit the required identification as a manufacturer, processor, or both; Order
response; draft study plan; final study plan; or final test report to the EPA by the deadline(s) specified in
this Order and intend to seek additional time to meet the requirement(s), you must submit a request to
the Agency through the 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.
The EPA will grant or deny deadline extension requests at its discretion.
IV. RESPONDING TO THIS ORDER
You are required to respond to this Order even if you believe your company is not subject to this Order.
Failure to provide a response is a violation of section 15 of TSCA.
11
A. IDENTIFY AS A MANUFACTURER, PROCESSOR, OR BOTH
Within 30 calendar days of the effective date of this Order, you, as a recipient of this Order, are required
to respond to this Order through the EPA’s Central Data Exchange (CDX) portal, informing the Agency
whether you will be responding to this Order as manufacturer or processor (if you manufacture and
process the chemical, select manufacturer). To provide your preliminary response to this Order, you will
receive an e-mail from the EPA within five days of the Order being signed (i.e., by the effective date of
the Order) that provides a CDX Order number for purposes of complying with this Order.
You may claim that you are not subject to this Order if you (1) do not currently manufacture or process
the chemical(s) identified by this Order; (2) do not intend to manufacture or process the chemical(s)
within the period of testing provided by this Order (see Unit V); and (3) have not manufactured or
processed the chemical(s) at any time during the five years preceding the effective date of this Order.
See Unit VI.B.4 for more information on how to claim that you are not subject to this Order.
B. FOUR RESPONSE OPTIONS
A recipient has four available options for purposes of responding to this Order. See Unit III to review
the deadlines for this Order.
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 details on the steps of this response option, see Unit VI.
For more information on this Order’s required tests, required protocols/methodologies, and deadlines for
submission of test reports see Unit V and Appendix E.
Option 2: Submit Existing Information
If you choose to respond to this Order by submitting an existing study and/or other scientifically relevant
information that you believe the EPA has not considered, your response in the EPA’s CDX portal must
be submitted to the EPA 30 days after the effective date of the Order and include the study(ies) and/or
other scientifically relevant information, along with supporting rationale that explains how the study
and/or other scientifically relevant information meets part or all of the information or obviates the need
for the information described as necessary in Unit II.
The EPA’s determination regarding whether the study and/or other relevant information satisfies part or
all of the information or obviates the need for the information described as necessary in Unit II 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 other scientifically relevant information satisfies the need in lieu of the testing required
in this Order and/or the original testing requirement is no longer needed, the EPA will extinguish those
testing obligations from this Order that are no longer necessary, with respect to the appropriate
recipients of this Order. If the study was your only testing obligation under the Order, all your
obligations under this Order will be extinguished upon notification by the Agency.
12
If the EPA determines that the study and/or other scientifically relevant information does not satisfy that
need, you must modify your response in the EPA’s CDX portal to choose one of the other response
options in Unit IV within 10 calendar days of being notified by the Agency.
Note that the submission of existing information will not extend the deadline for the draft study plan
submission for that testing requirement unless the existing information is submitted within 30 days of
the effective date of the Order and the EPA does not respond within 45 days of the effective date of the
Order. Thus, failure to submit existing information prior to the 30-day deadline will result in a need to
submit a draft study plan by the 80-day deadline. See Unit III.B for information on the potential
automatic extension of deadlines.
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)).
The EPA will grant a request for exemption from the requirement to conduct tests and submit
information on a chemical substance if:
1. Information on the subject chemical or 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 (including this 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 (including
this Order), or consent agreement.
An exemption request must be submitted through the CDX portal and contain the following:
1. This Order number, the chemical identity, and the CAS Registry 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/are developing information for the subject chemical or 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 (“chemical data or biological test data intended to show that two
substances or mixtures are equivalent” (see Appendix A)), if data on an equivalent chemical is
being submitted.
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.
13
8. A Statement of Financial Responsibility: The following sworn statement (i.e., signed and
notarized) must accompany each request for an exemption:
“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.”
The 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 the Agency. If the EPA subsequently determines that equivalent data has not
been submitted in accordance with the applicable rule, order, or consent agreement, the Agency will
provide notice through CDX of its preliminary decision 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
the EPA’s preliminary decision to terminate the exemption or notify the Agency of its intent to develop
the required information pursuant to the specifications established in this Order and any modifications
approved by the EPA. If the exemption holder submits information to rebut the EPA's preliminary
decision to terminate the exemption, then the Agency will provide the exemption holder an opportunity
to request a hearing prior to issuing a final decision to terminate the exemption. Following the receipt of
information to rebut the EPA’s preliminary decision and any subsequent hearing, the Agency will render
a final decision on whether to terminate the exemption, taking into account information submitted to
rebut the EPA’s preliminary decision and information presented at any hearing, as applicable.
If you receive the EPA's preliminary decision to terminate the exemption and do not submit information
to rebut that preliminary decision or request a hearing, or if you receive the Agency’s final decision to
terminate the exemption following the submission of information to rebut that preliminary decision or a
hearing, you must resubmit a response in accordance with one of the options described in Unit IV.B of
this Order within 30 calendar days of receipt of the EPA's decision to terminate the exemption, including
as applicable the information required under Unit V of this Order. Failure to timely resubmit the
response will constitute a violation of this Order and of TSCA section 15(1). Should the Agency
terminate the exemption, a draft study plan will be due 30 days from the termination, with the final study
plan being due 60 days from the termination.
If the EPA extinguishes a testing obligation pursuant to Unit IV.B.2 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.
As explained in Appendix 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 the 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 Appendix B that the Agency order
reimbursement, the Administrator shall order the person granted the exemption to provide fair and
equitable reimbursement. See TSCA section 4(c).
14
Option 4: Claim that You Are Not Subject to this Order
You may claim that you are not subject to this Order if you do not manufacture or process the
chemical(s) identified by this Order; do not intend to manufacture or process the chemical(s) within the
period of testing provided by this Order (see Unit V); and have not manufactured or processed the
chemical(s) at any time during the five years preceding the effective date of this Order.
An explanation of the basis for your claim, along with appropriate supporting information to substantiate
that claim, must accompany your response in the CDX portal so that the EPA can evaluate the claim.
Note that if your company ceased manufacturing (including import) or processing of the chemical
substance(s) subject to this Order more than five years prior to the effective date of this Order, you can
claim that you are not subject to this Order.
In the instance that you claim you are Not Subject to this Order, your claim must include (1) a statement
explaining why your company is not subject to this Order, such as no longer importing, manufacturing
or processing the subject chemical substance (intentionally or unintentionally) within the five years prior
to the effective date of this Order, and not intending to manufacture (including import) or process the
chemical within the period of testing provided by this Order (see Unit V), and (2) the 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.”
If based on the evidence you provide and other evidence available to the EPA, the Agency deems your
claim to be inadequately substantiated, the EPA will deny your claim, and the original requirements and
deadlines in this Order will remain. If your claim is approved, the Agency will notify you that you are
not subject to this Order through CDX correspondence. The EPA expects to provide such notification
within 45 days of the effective date of this Order.
To select this option, you must do so within 45 days of the effective date of this Order.
V. OVERVIEW OF TESTING REQUIRED BY THIS ORDER
This unit applies to Option 1: Develop the Information and Option 2: Submit Existing Information
(Units IV.B.1 and IV.B.2).
Where the required protocol is an EPA guideline, the guideline is available on the EPA website at
http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances 4 and from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel: 703605-6000). This EPA website also provides information on OECD guidelines, which are also available
via OECD’s website at https://www.oecd.org/chemicalsafety/testing 5. Appendix E provides additional
sources for guidelines associated with specific testing.
The 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 the EPA’s scientific judgment obviates
4
5
http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances
https://www.oecd.org/chemicalsafety/testing
15
the need for specific test data required under this Order. Specific information for ordered test(s) are
provided in Appendix E.
See Appendix E for details on the required test protocols.
Table 3. Entities Responsible and Deadlines for Required Testing Protocol(s)/Methodology(ies)
Deadlines that fall on a weekend or holiday will remain and will not be extended to the next weekday.
Test Names
Protocols Methodologies
Entities
Deadlines to
Responsible for
Submit Final
Testing
Reports to EPA
Environmental Hazard
Earthworm Reproduction Test (Eisenia fetida/Eisenia
andrei)
OECD 222 (2016)
Manufacturers
215 days after
effective date of
the Order
Avian Dietary Toxicity Test
OCSPP 850.2200
Manufacturers
165 days after
effective date of
the Order
Avian Reproduction Test
OCSPP 850.2300
Manufacturers
295 days after
effective date of
the Order
Exposure Testing Protocol
3: Short-Term Emission
Testing (U.S. EPA, 2017)
Manufacturers
and Processors
215 days after
effective date of
the Order
Consumer Exposure
Emission Rate From Use of Cleaning and Furnishing
Care Products, Such as Stone Polish/Sealer Containing
1,2-Dichloropropane in the Form of Wax and/or Paste,
Liquid, and Spray Through Chamber Testing
VI. REQUIREMENTS OF RESPONSE OPTION 1: DEVELOP THE INFORMATION
REQUIRED BY THIS ORDER
A. OVERVIEW
The draft study plan is due to the EPA 80 days after the effective date of this Order. The EPA will then
review the draft study plan and provide input to ensure adequacy of the final study plan. For the final
study plans and the final test reports, see the Deadlines for Responses, Study Plans, and Test Reports
table in Unit III.A.
All testing described in Unit V must be conducted in accordance with the Good Laboratory Practice
(GLP) standards in 40 CFR part 792, as specified in the CFR on the Effective Date of this Order. You
must provide a statement of compliance with these GLP standards when submitting information to the
EPA pursuant to this Order.
Deviations from the test guideline or specific GLP standards are allowed provided justifications for such
deviations are approved by the EPA. A justification is required for each deviation. Justifications should
demonstrate that, despite the deviation from the given test guideline or GLP standard, that data integrity,
control of bias, and study quality will be maintained with similar effectiveness. Any requested
deviations and corresponding justifications must be included in the draft study plan for the Agency's
consideration and, if approved, described in the test report.
16
Once the EPA has completed its review of the submitted test reports and accepts the information as fully
complying with your testing obligations under this Order, the Agency will notify you.
B. DRAFT STUDY PLAN REQUIREMENTS
1. Study Plan Requirements for All Categories of Tests
If you choose to develop the required information to comply with this Order, you must obtain and
review the required protocols/methodologies. Unit V and Appendix E provide the
protocols/methodologies that must be followed to perform each required test.
If questions and/or issues arise during Study Plan development, the EPA encourages
questions/comments be submitted along with the Study Plan submission in accordance with the draft
study plan deadline. If the Agency's review of the draft study plan that includes the questions/comments
is delayed, the procedure outlined in Unit III.B will be followed for automatic extensions of the study
plan.
In addition to requirements provided in Appendix E for a given test required by this Order, the Study
Plans must contain the following information:
1. This Order number, excluding the unique 6-digit company number using X’s in place of the
unique company number so as to protect each company’s private access to the reporting module
via Central Data Exchange (CDX). For example, if your Order number is TO-2020-0000438435-00-0 then provide this number in the Study Plan: TO-2020-0000-XXXXXX-00-0.
2. Name of test to be covered by the test protocol/methodology.
3. The name/number of the protocol/methodology identified in this Order which you intend to
follow, a copy of the identified protocol/methodology with your proposed modifications, or a
copy of the alternate protocol/methodology you propose to use. Justification(s) must be provided
for any deviation from the protocol/methodology provided in this Order.
4. The identity of 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. A Certificate of Analysis of the test
substance must be provided.
5. The sampling and analytical method that will be used.
6. 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.
7. A description of all quality assurance and quality control protocols used.
8. The name(s) and address(es) of the company(ies) sponsoring the test and whether they comprise
a testing consortium.
17
9. The name(s), mailing address(es), phone number(s), and e-mail address(es) of the appropriate
individual(s) for the EPA to contact concerning the planned test.
10. 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.
2. Modifying a Required Protocol/Methodology in a Draft Study Plan
The draft study plan must include the required protocols/methodologies outlined in Unit VI.A.1 and
Appendix E. If you believe modifications of these required protocols/methodologies are necessary, you
should propose the modification in the draft study plan and submit to the EPA with request for the
Agency to consider the modifications. Any consultation regarding modifications to the required
protocols/methodologies will not extend the deadline for submission of the draft study plan.
Any submitted requests for modifications of the required protocols/methodologies must include a
detailed description of the proposed modification as well as a detailed description of the justification and
reasoning for such modifications. Requests for modifications of protocol/methodology or the use of an
alternate protocol/methodology must discuss why such changes are appropriate and whether they could
alter the validity of the study. 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 section of the study plan describing the
protocols/methodologies.
If the 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 the EPA will approve your study plan. The Agency has 15 days from the deadline for the study
plan to respond. For each day following this period that the EPA does not respond, the Agency will
extend the deadline for the final study plan by one day (see Unit III).
3. EPA Review of Study Plans and Final Test Report
The EPA will not conduct a substantive review of any draft study plan that does not meet the
requirements as provided in Unit IV.B.1 and Appendix E. Such a submission does not constitute
meeting the deadline for the draft study plan submission. Unit III provides information on deadlines and
the EPA response timelines.
Failure to submit a draft study plan, final study plan, and final test report which do not fully comply with
the terms of this Order and by the deadlines provided in Unit III may result in a violation of TSCA
section 15.
a. Study Plans
Following review of a draft study plan submission, the EPA will indicate what modifications, if any, are
required and must be incorporated into the final study plan. Accompanying a proposed final study plan
submission, the submitter must provide a clean and red-lined version. The red-lined version will indicate
the changes incorporated into the final study plan as compared with the draft study plan submission.
If the EPA requires modifications to a submitted draft study plan, the Agency may elect to provide a
line-by-line list of comments that must be addressed and corrected before a final study plan will be
18
approved. If the submitter receives a line-by-line list of comments, the submitter must address each
individual comment and include this in their response to the Agency along with the proposed final study
plan.
Prior to initiating any test, the Company/Consortium must first address the EPA’s input on the study
plan and receive the Agency's acceptance of the final study plan.
The EPA’s acceptance of a final study plan does not constitute pre-acceptance of any future test results.
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.
If, after the final study plan has been approved or after testing is underway, you wish to make a
modification to an identified protocol/methodology or use a different protocol/methodology, you must
submit a request to the EPA to make these changes in your study and you must still meet the deadlines
set out in Unit V and Appendix E for the relevant test or request an extension (see also Unit III.C), if
needed.
Note that submitting questions to the EPA regarding study plan requirements will not extend the
deadline for a study plan submission
b. Final Test Reports
Once the EPA has completed its initial review and accepted data for all test reports subject to this Order
for a given testing requirement, the Agency will notify the designated contact for the company or
consortium subject to this Order that this testing requirement has been satisfied, which in turn will close
out the testing requirement of this Order for the companies and participants in any consortium subject to
this Order. Failure to file a final test report meeting all the requirements in this Order by the deadline
in Unit III is a violation of TSCA. Your final test report must be submitted along with the data in the
associated Organisation for Economic Co-operation and Development (OECD) harmonized template
format, if available. OECD harmonized templates can be located at
https://www.oecd.org/ehs/templates/harmonised-templates.htm 6:
Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei), OECD 222 (2016)
• Harmonized Template Identifier: 50-1
Avian Dietary Toxicity Test, OCSPP 850.2200
• Harmonized Template Identifier: 53
Avian Reproduction Test, OCSPP 850.2300
• Harmonized Template Identifier: 53
6
https://www.oecd.org/ehs/templates/harmonised-templates.htm
19
VII. FEES FOR SUBMITTING INFORMATION
Per 40 CFR § 700.45, and taking into account the inflation adjustment that went into effect on January 1,
2022, the Test Order fee is $11,650 to be split evenly among the manufacturers who are required to test
a chemical substance or mixture subject to the Test Order (accounting for small business
considerations). Processors are not subject to this fee, nor are manufacturers who submit existing
information or receive an exemption in compliance with this Order.
Small businesses may be subject to no more than 20% of the amount of the applicable fee. A company
may qualify for a “small business concern” discount if their total number of employees is at or below the
maximum allowed in the final rule for that company's North American Industry Classification System
(NAICS) code (see 40 CFR 700.43). In order for an entity to qualify as a “small business concern,” its
number of employees shall not exceed the size standard for the applicable industry. When calculating
the number of employees, the company must include the employees of all parent and subsidiary
companies within the corporate chain. Please note that small business fees are only applicable to
qualifying small businesses who are either not associated with a consortium or associated with an allsmall business consortium. See this webpage for more information: https://www.epa.gov/tsca-fees/tscafees-and-small-businesses 7.
A company can identify itself as a small business when responding to this Order via the CDX
application. The “small business concern” discount will be included in the determination of companyspecific invoices for the distribution of the $11,650 fee across all manufacturers conducting testing for
the given Test Order. Where a consortium is responsible for the fee for its members for purposes of this
Order, and at least one of the members is not a small business, the EPA does not apply a “small business
concern” discount to the portion of the $11,650 distributed to the consortium.
Fees for Test Orders under TSCA section 4 will be invoiced electronically by the EPA. Invoice notices
will be populated into the specific user's “Copy of Record” screen in CDX and will contain a button that
will initiate the payment process. When an invoice is generated, notification e-mails will be sent to the
user's CDX inbox and the e-mail address associated with the relevant CDX account. Payment
information will be collected in CDX and then submitted to Pay.gov for processing.
Note that there are many fees associated with TSCA-related activities. See this webpage for more
information: https://www.epa.gov/tsca-fees/tsca-fees-table 8. The TSCA section 4 Test Order fee is
separate from these fees. A company’s inclusion in or exclusion from other TSCA fees is unrelated to
that company’s status with regards to TSCA section 4 Test Order fees.
Pursuant to 40 CFR § 700.45, the applicable fee shall be paid in full no later than 120 days after the
effective date of the Order. Should the EPA invoice the fee more than 90 days after the effective date of
the Order, payment will be due within 30 days of such invoicing.
VIII. 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 Order recipients who are participants in the consortium) must, individually in
the CDX portal, state your intention to participate in a testing consortium for each specific chemical and
7
8
https://www.epa.gov/tsca-fees/tsca-fees-and-small-businesses
https://www.epa.gov/tsca-fees/tsca-fees-table
20
specific test. Consortium participants must individually respond in the CDX portal with their intent to
participate before designated leads are able to add them to the consortium.
In addition, the designated lead for the consortium must submit a consortium response to the EPA in the
CDX portal. 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 response must also include contact information for the designated
lead of the consortium, who must be domiciled in the United States. The designated lead for the
consortium must submit the response and required information on behalf of the consortium and its
member companies by the deadlines listed in Unit III.A. Submissions made on behalf of the consortium
must be in accordance with instructions in Appendix C. Note that a consortium lead need not be a
recipient of an Order; other entities (such as trade organizations) may act as a lead and submit the
information required under this Order. After the results of the last required test of this Order are
submitted and the EPA accepts the information as complying with this Order, or the Agency accepts
existing information submitted by the Consortium, the EPA will provide notification of compliance with
this Order to this Order’s 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 this Order (with the study plan and results being submitted by the consortium)
and is individually liable in the event of any failure to comply with this Order. If the consortium fails to
submit the information or meet any of the requirements of this Order on your behalf, you will be in
violation of this 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 Appendix B.
IX. 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 this 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 the EPA protect as CBI must be clearly
identified as such when submitted. For sections of the report that are claimed as CBI, the report must be
accompanied by a sanitized version of the report only removing the specific information claimed as CBI.
A sanitized test report that redacts all or most of the study may be rejected by the Agency as not
satisfying the requirements of this Order.
When claiming information as CBI, you must certify to the following:
“I hereby certify to the best of my knowledge and belief that all information entered on this form
21
is complete and accurate.
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-substantiations.
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 the 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, the Agency may review claims prior to
the expiration of the 10-year period.
Under circumstances stated in TSCA section 14(d), the EPA may disclose information claimed as CBI
to other persons including, for example, Federal and State authorities, health and environmental
professionals, poison control centers, and emergency responders.
X. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS ORDER
Failure to comply with any of the requirements in this Order is a violation of TSCA section 15 and could
subject you to civil and/or criminal penalties under TSCA section 16, 15 U.S.C. § 2615 as modified by
the Federal Civil Penalties Inflation Adjustment Act. Each day that failure to meet the requirements
continues constitutes a separate violation.
XI. REFERENCES
The following is a listing of the documents that are generally applicable to this Order. Appendix E
provides references specific to certain testing requirements in this Order. Please note that references,
22
guidance, and information from additional sources could be considered, with EPA approval, during the
development of study plans.
The docket includes these documents and other information considered by the EPA, including
documents that are referenced within the documents that are included in the docket, even if the
referenced document is not physically located in the docket. For assistance in locating these other
documents, please consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.
General References for this Test Order
1. U.S. EPA (2021). 1,2-Dichloropropane Test Order [EPA-HQ-OPPT-2018-0428]. Washington
DC: U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention
(OCSPP).
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-4a2-test-order12-dichloropropane 9
2. U.S. EPA (2020a) Final Scope of the Risk Evaluation for 1,2-Dichloropropane [EPA-740-R20-006]. Washington DC: U.S. Environmental Protection Agency, Office of Chemical Safety
and Pollution Prevention (OCSPP).
https://www.epa.gov/sites/default/files/2020-09/documents/casrn_78-87-5_12dichloropropane_finalscope.pdf 10
3. U.S. EPA (2020b). Use Report for 1,2-Dichloropropane (CASRN 78-87-5) [EPA-HQ-OPPT2018-0428]. Washington DC: U.S. Environmental Protection Agency, Office of Pollution
Prevention and Toxics (OPPT).
https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0428-0021 11
Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) References
4. OECD (Organisation for Economic Co-operation and Development). (2016). Test No. 222:
Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei). Paris, France: OECD Guidelines
for the Testing of Chemicals, Section 2, OECD Publishing.
https://doi.org/10.1787/9789264264496-en 12
Avian Dietary Toxicity Test References
5. CalEPA (California Environmental Protection Agency). (1999). Public Health Goal for 1,2Dichloropropane in Drinking Water. [Sacramento, California]: California Environmental
Protection Agency, Office of Environmental Health Hazard Assessment, Pesticide and
Environmental Toxicology Section.
https://oehha.ca.gov/media/downloads/water/chemicals/phg/12dcpf.pdf 13
6. OECD (Organisation for Economic Co-operation and Development). (2006). SIDS Initial
Assessment Report: 1,2-Dichloropropane (CASRN: 78-87-5) (pp. 219). Paris, France: United
9
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-4a2-test-order-12-dichloropropane
https://www.epa.gov/sites/default/files/2020-09/documents/casrn_78-87-5_12-dichloropropane_finalscope.pdf
11
https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0428-0021
12
https://doi.org/10.1787/9789264264496-en
13
https://oehha.ca.gov/media/downloads/water/chemicals/phg/12dcpf.pdf
10
23
Nations Environment Programme, Organisation for Economic Co-operation and Development.
https://hpvchemicals.oecd.org/ui/handler.axd?id=E6CE93C6-9DD5-41DF-ADE686ECABD0F533 14
7. RIVM (Dutch National Institute for Public Health and the Environment). (2007).
Ecotoxicologically Based Environmental Risk Limits for Several Volatile Aliphatic
Hydrocarbons (pp. 217). (601782002/2007). Bilthoven, Netherlands: National Institute for
Public Health and the Environment (RIVM).
https://www.rivm.nl/bibliotheek/rapporten/601782002.pdf 15
8. U.S. EPA (2012). OCSPP 850.2200: Avian Dietary Toxicity Test [EPA 712-C-024].
Washington DC: U.S. Environmental Protection Agency, Office of Chemical Safety and
Pollution Prevention (OCSPP). https://www.regulations.gov/document/EPA-HQ-OPPT-20090154-0011 16
9. U.S. EPA (2020). Final Guidance for Waiving Sub-Acute Avian Dietary Tests for Pesticide
Registration and Supporting Retrospective Analysis. United States Environmental Protection
Agency’s Office of Pesticide Programs (OCSPP).
https://www.epa.gov/sites/default/files/2020-02/documents/final-waiver-guidance-avian-subacute-dietary.pdf 17
10. USGS (U.S. Geological Survey). (1991). USGS Monitoring Data: National Water Quality
Monitoring Council [Database] – Air, Groundwater, Sediment, Soil, Surface Water, Tissue.
http://www.waterqualitydata.us/portal/ 18
Avian Reproduction Test References
11. CalEPA (California Environmental Protection Agency). (1999). Public Health Goal for 1,2Dichloropropane in Drinking Water. [Sacramento, California]: California Environmental
Protection Agency, Office of Environmental Health Hazard Assessment, Pesticide and
Environmental Toxicology Section.
https://oehha.ca.gov/media/downloads/water/chemicals/phg/12dcpf.pdf 19
12. OECD (Organisation for Economic Co-operation and Development). (2006). SIDS Initial
Assessment Report: 1,2-Dichloropropane (CASRN: 78-87-5) (pp. 219). Paris, France: United
Nations Environment Programme, Organisation for Economic Co-operation and Development.
https://hpvchemicals.oecd.org/ui/handler.axd?id=E6CE93C6-9DD5-41DF-ADE686ECABD0F533 20
13. RIVM (Dutch National Institute for Public Health and the Environment). (2007).
Ecotoxicologically Based Environmental Risk Limits for Several Volatile Aliphatic
Hydrocarbons (pp. 217). (601782002/2007). Bilthoven, Netherlands: National Institute for
14
https://hpvchemicals.oecd.org/ui/handler.axd?id=E6CE93C6-9DD5-41DF-ADE6-86ECABD0F533
https://www.rivm.nl/bibliotheek/rapporten/601782002.pdf
16
https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0011
17
https://www.epa.gov/sites/default/files/2020-02/documents/final-waiver-guidance-avian-sub-acute-dietary.pdf
18
http://www.waterqualitydata.us/portal/
19
https://oehha.ca.gov/media/downloads/water/chemicals/phg/12dcpf.pdf
20
https://hpvchemicals.oecd.org/ui/handler.axd?id=E6CE93C6-9DD5-41DF-ADE6-86ECABD0F533
15
24
Public Health and the Environment (RIVM).
https://www.rivm.nl/bibliotheek/rapporten/601782002.pdf 21
14. U.S. EPA (2012). OCSPP 850.2300: Avian Reproduction Test [EPA 712C-023]. U.S.
Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention
(OCSPP). https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0012 22
15. USGS (U.S. Geological Survey). (1991). USGS Monitoring Data: National Water Quality
Monitoring Council [Database] – Air, Groundwater, Sediment, Soil, Surface Water, Tissue.
http://www.waterqualitydata.us/portal/ 23
Emission Rate From Use of Cleaning and Furnishing Care Products, Such as Stone Polish/Sealer
Containing 1,2-Dichloropropane in the Form of Wax and/or Paste, Liquid, and Spray Through Chamber
Testing Test References
16. U.S. EPA (1999a). Method TO-14A: Determination of Volatile Organic Compounds (VOCs)
in Ambient Air Using Specially Prepared Canisters with Subsequent Analysis by Gas
Chromatography [EPA/625/R-96/010b], Compendium of Methods for the Determination of
Toxic Organic Compounds in Ambient Air, 2nd ed. Cincinnati, OH: U.S. Environmental
Protection Agency, Office of Research and Development, Center for Environmental Research
Information.
https://www.epa.gov/sites/default/files/2019-11/documents/to-14ar.pdf 24
17. U.S. EPA (1999b). Method TO-15: Determination of Volatile Organic Compounds (VOCs)
in Air Collected in Specially-Prepared Canisters and Analyzed by Gas Chromatography/Mass
Spectrometry (GC/MS) [EPA/625/R-96/010b], Compendium of Methods for the Determination
of Toxic Organic Compounds in Ambient Air, 2nd ed. Cincinnati, OH: U.S. Environmental
Protection Agency, Office of Research and Development ,Center for Environmental Research
Information. https://www.epa.gov/sites/default/files/2019-11/documents/to-15r.pdf 25
18. U.S. EPA (2017). Indoor Exposure Product Testing Protocols, Version 2.0 [740-S1-7002].
[Washington, DC]: U.S. Environmental Protection Agency, Office of Chemical Safety and
Pollution Prevention (OCSPP). https://www.epa.gov/sites/default/files/201801/documents/indoor_exposure_testing_protocols_version_2.pdf 26
XII. 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
21
https://www.rivm.nl/bibliotheek/rapporten/601782002.pdf
https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0012
23
http://www.waterqualitydata.us/portal/
24
https://www.epa.gov/sites/default/files/2019-11/documents/to-14ar.pdf
25
https://www.epa.gov/sites/default/files/2019-11/documents/to-15r.pdf
26
https://www.epa.gov/sites/default/files/2018-01/documents/indoor_exposure_testing_protocols_version_2.pdf
22
25
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.
XIII. FOR FURTHER INFORMATION CONTACT
For technical information contact: [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].
XIV. 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.]
Dated: Click or tap to enter eSignature date.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
Enclosures
26
APPENDIX 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, the 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.
27
APPENDIX B - COST SHARING
The 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 this Order. They are forming or joining a consortium,
discussed in Unit VIII, or requesting an exemption, discussed in Unit IV.B.3.
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 the EPA's participation. The Agency has promulgated regulations that explain how the
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, the 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 part 791.
28
APPENDIX C - HOW TO ACCESS THE CDX APPLICATION AND RECORDKEEPING
REQUIREMENTS
How to Access the CDX Application
The initial response, draft 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 the EPA
as follows:
1. Submit to the EPA’s 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/ 27 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 the EPA Internet
homepage at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronicreporting-requirements-certain-information#data 28.
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.
The EPA may revise these submission instructions with advance notice.
Recordkeeping
You must retain copies of all information documenting your compliance with this Order for ten years.
This includes your 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.
27
https://cdx.epa.gov/
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronic-reporting-requirements-certaininformation#data
28
29
APPENDIX D - ORDER RECIPIENT SELECTION
This Appendix describes the process by which the EPA identified recipients of this Order. This
information is for your use, and does not govern the obligations under this Order or the identities of the
companies subject to this Order. A recipient of this Order that manufactures or processes the chemical as
per the definitions provided in Unit I.B is subject to this Order, regardless of the basis on which the
Agency identified the recipient.
The manufacturers and processors of the chemical subject to this Order were determined in the
following manner:
The EPA included in this Order as recipients all companies comprising the final list of manufacturers
subject to fee payments 29 for p-dichlorobenzene developed under the “Fees for Administration of Toxic
Substances Control Act” rule in 2020, as well as, manufacturers identified by other sources, including
Toxics Release Inventory 30 (TRI) reporting from 2016 to 2020 and Chemical Data Reporting (CDR)
reporting from 2020. The Agency also included in this Order Companies who reported as “Processors”
of this chemical to the 2016 to 2020 TRI. Although the 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.
29
30
https://www.epa.gov/tsca-fees/final-list-fee-payers-next-20-risk-evaluations
https://www.epa.gov/toxics-release-inventory-tri-program
30
APPENDIX E - SPECIFIC REQUIREMENTS AND GUIDANCE FOR THIS ORDER
This appendix provides requirements of study plans and test reports for specific testing requirements of
this Order. Additionally, this appendix provides additional reference material(s) associated with the
testing required in this Order.
For information on how the EPA determined the need for the testing requirements of this Order, refer to
Unit II.B.
I. ENVIRONMENTAL HAZARD
a. Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei), OECD 222 (2016)
i. Study Plans
Please see Unit VI.B of the Order for overall requirements for study plans. Additional requirements
specific to OECD 222 include:
1. Final exposure concentrations must capture both lethal and sub-lethal effects over a period of
8-weeks, such that they bracket the Effective Concentration (ECx) estimate. To ensure these
requirements are met, it is highly recommended that a range finding test is conducted before the
initiation of the definitive test.
2. Soil must be mixed and homogenized with the chemical, and the source, purity, and a
Certificate of Analysis of the test substance must be reported. The draft study plan will not be
approved by the EPA without the purity of the test material.
3. The analytical laboratory must describe how they will conduct analytical verification of the
test material at the beginning and end of the test, and every 7-days throughout the test duration.
4. A description must be provided as to whether the use of formulated/artificial or field-collected
soil is being implemented (the EPA recommends formulated/artificial soil).
5. An outline must be provided of the raw data to be collected for each sub-lethal and lethal
endpoint as well as statistical analyses that are planned.
6. Because 1,2-dichloropropane is a volatile substance, a description must be provided as to how
the test laboratory will account for volatilization.
ii. Test Reports
In addition to the requirements provided by Unit VI, test reports submitted to the EPA are due 215 days
after effective date of the Order and must include the following, as applicable:
1. Harmonized Template ID: 50-1
31
2. Harmonized Template URL: https://www.oecd.org/ehs/templates/harmonised-templateseffects-on-biotic-systems.htm 31
iii. References
In addition to generally applicable references provided by Unit XI, the following is a list of references
specific to this testing requirement:
1. OECD (Organisation for Economic Co-operation and Development). (2016). Test No. 222:
Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei). Paris, France: OECD Guidelines
for the Testing of Chemicals, Section 2, OECD Publishing.
https://doi.org/10.1787/9789264264496-en 32
b. Avian Dietary Toxicity Test (OCSPP 850.2200)
i. Study Plans
Please see Unit VI.B of the Order for overall requirements for study plans. Additional requirements
specific to OCSPP 850.2200 include:
1. An outline must be provided of the raw data to be collected for each endpoint as well as
statistical analyses that are planned.
2. The study laboratory must describe how they will conduct analytical verification of the test
material in the diet at the beginning, middle and end of the test to ensure exposure, and the
source, purity, and a Certificate of Analysis of the test substance must be reported. The draft
study plan will not be approved by the EPA without the purity of the test material.
3. A description should be provided as to how frequently the test diets will be mixed, to ensure
for volatile substance that the concentrations are not reduced from initial concentrations by more
than 20%.
4. The Northern bobwhite (Colinus virginianus) must be used instead of the mallard (Anas
platyrhynchos) or other test species recommended in the guideline, because it is less prone to
regurgitation and easier to measure food consumption for this species.
ii. Test Reports
In addition to the requirements provided by Unit VI, test reports submitted to the EPA are due 165 days
after effective date of the Order and must include the following, as applicable:
1. Harmonized Template ID: 53
2. Harmonized Template URL: https://www.oecd.org/ehs/templates/harmonised-templateseffects-on-biotic-systems.htm 33
31
https://www.oecd.org/ehs/templates/harmonised-templates-effects-on-biotic-systems.htm
https://doi.org/10.1787/9789264264496-en
33
https://www.oecd.org/ehs/templates/harmonised-templates-effects-on-biotic-systems.htm
32
32
iii. References
In addition to generally applicable references provided by Unit XI, the following is a list of references
specific to this testing requirement:
1. CalEPA (California Environmental Protection Agency). (1999). Public Health Goal for 1,2Dichloropropane in Drinking Water. [Sacramento, California]: California Environmental
Protection Agency, Office of Environmental Health Hazard Assessment, Pesticide and
Environmental Toxicology Section.
https://oehha.ca.gov/media/downloads/water/chemicals/phg/12dcpf.pdf 34
2. OECD (Organisation for Economic Co-operation and Development). (2006). SIDS Initial
Assessment Report: 1,2-Dichloropropane (CASRN: 78-87-5) (pp. 219). Paris, France: United
Nations Environment Programme, Organisation for Economic Co-operation and Development.
https://hpvchemicals.oecd.org/ui/handler.axd?id=E6CE93C6-9DD5-41DF-ADE686ECABD0F533 35
3. RIVM (Dutch National Institute for Public Health and the Environment). (2007).
Ecotoxicologically Based Environmental Risk Limits for Several Volatile Aliphatic
Hydrocarbons (pp. 217). (601782002/2007). Bilthoven, Netherlands: National Institute for
Public Health and the Environment (RIVM).
https://www.rivm.nl/bibliotheek/rapporten/601782002.pdf 36
4. U.S. EPA (2012). OCSPP 850.2200: Avian Dietary Toxicity Test [EPA 712-C-024].
Washington DC: U.S. Environmental Protection Agency, Office of Chemical Safety and
Pollution Prevention (OCSPP). https://www.regulations.gov/document/EPA-HQ-OPPT-20090154-0011 37
5. U.S. EPA (2020). Final Guidance for Waiving Sub-Acute Avian Dietary Tests for Pesticide
Registration and Supporting Retrospective Analysis. United States Environmental Protection
Agency’s Office of Pesticide Programs (OCSPP). https://www.epa.gov/sites/default/files/202002/documents/final-waiver-guidance-avian-sub-acute-dietary.pdf 38
6. USGS (U.S. Geological Survey). (1991). USGS Monitoring Data: National Water Quality
Monitoring Council [Database] – Air, Groundwater, Sediment, Soil, Surface Water, Tissue.
http://www.waterqualitydata.us/portal/ 39
c. Avian Reproduction Test (OCSPP 850.2300)
i. Study Plans
Please see Unit VI.B of the Order for overall requirements for study plans. Additional requirements
specific to OCSPP 850.2300 include:
34
https://oehha.ca.gov/media/downloads/water/chemicals/phg/12dcpf.pdf
https://hpvchemicals.oecd.org/ui/handler.axd?id=E6CE93C6-9DD5-41DF-ADE6-86ECABD0F533
36
https://www.rivm.nl/bibliotheek/rapporten/601782002.pdf
37
https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0011
38
https://www.epa.gov/sites/default/files/2020-02/documents/final-waiver-guidance-avian-sub-acute-dietary.pdf
39
http://www.waterqualitydata.us/portal/
35
33
1. An outline must be provided of the raw data to be collected for each sub-lethal and lethal
endpoint as well as statistical analyses that are planned.
2. The study laboratory must describe how they will conduct analytical verification of the test
material in the diet at the beginning, middle and end of the test to ensure exposure, and the
source, purity, and a Certificate of Analysis of the test substance must be reported. The draft
study plan will not be approved by the EPA without the purity of the test material.
3. A description should be provided as to how frequently the test diets will be mixed, to ensure
for volatile substance that the concentrations are not reduced from initial concentrations by more
than 20%.
4. The Northern bobwhite (Colinus virginianus) must be used instead of the mallard (Anas
platyrhynchos) or other test species recommended in the guideline, because it is less prone to
regurgitation and easier to measure food consumption for this species.
ii. Test Reports
In addition to the requirements provided by Unit VI, test reports submitted to the EPA are due 295 days
after effective date of the Order and must include the following, as applicable:
1. Harmonized Template ID: 53
2. Harmonized Template URL: https://www.oecd.org/ehs/templates/harmonised-templateseffects-on-biotic-systems.htm 40
iii. References
In addition to generally applicable references provided by Unit XI, the following is a list of references
specific to this testing requirement:
1. CalEPA (California Environmental Protection Agency). (1999). Public Health Goal for 1,2Dichloropropane in Drinking Water. [Sacramento, California]: California Environmental
Protection Agency, Office of Environmental Health Hazard Assessment, Pesticide and
Environmental Toxicology Section.
https://oehha.ca.gov/media/downloads/water/chemicals/phg/12dcpf.pdf 41
2. OECD (Organisation for Economic Co-operation and Development). (2006). SIDS Initial
Assessment Report: 1,2-Dichloropropane (CASRN: 78-87-5) (pp. 219). Paris, France: United
Nations Environment Programme, Organisation for Economic Co-operation and Development
https://hpvchemicals.oecd.org/ui/handler.axd?id=E6CE93C6-9DD5-41DF-ADE686ECABD0F533 42
3. RIVM (Dutch National Institute for Public Health and the Environment). (2007).
Ecotoxicologically Based Environmental Risk Limits for Several Volatile Aliphatic
Hydrocarbons (pp. 217). (601782002/2007). Bilthoven, Netherlands: National Institute for
40
https://www.oecd.org/ehs/templates/harmonised-templates-effects-on-biotic-systems.htm
https://oehha.ca.gov/media/downloads/water/chemicals/phg/12dcpf.pdf
42
https://hpvchemicals.oecd.org/ui/handler.axd?id=E6CE93C6-9DD5-41DF-ADE6-86ECABD0F533
41
34
Public Health and the Environment (RIVM).
https://www.rivm.nl/bibliotheek/rapporten/601782002.pdf 43
4. U.S. EPA (2012). OCSPP 850.2300: Avian Reproduction Test [EPA 712C-023]. U.S.
Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention
(OCSPP). https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0012 44
5. USGS (U.S. Geological Survey). (1991). USGS Monitoring Data: National Water Quality
Monitoring Council [Database] – Air, Groundwater, Sediment, Soil, Surface Water, Tissue.
http://www.waterqualitydata.us/portal/ 45
II. CONSUMER EXPOSURE
a. Emission Rate From Use of Cleaning and Furnishing Care Products, Such as Stone
Polish/Sealer Containing 1,2-Dichloropropane in the Form of Wax and/or Paste, Liquid,
and Spray Through Chamber Testing (Exposure Testing Protocol 3: Short-Term Emission
Testing (U.S. EPA, 2017))
i. Study Plans
Please see Unit VI.B of the Order for overall requirements for study plans. Additional requirements
specific to Exposure Testing Protocol 3 (U.S. EPA, 2017) include:
1. Identify all products in all available forms (i.e. wax and/or paste, liquid, and spray) matching
description in test order.
2. For each product example and form, identify all products that contain DCP. If more than 10
product examples are identified, select 50% of the product examples with limited variability
across the components for those products.
3. Follow the test protocol recommendations for the number of samples. Test Protocol 3
specifies at least 6 samples at each elapsed time.
4. To obtain emission rates from products in all forms, follow Test Protocol 3 section 3.3.2.4 and
the recommended approaches for sample setup inside the micro chamber.
5. Chamber temperature and relative humidity settings should mimic indoor environments, 1824°C (65-75°F), 30-50% respectively.
6. TO-14a (U.S. EPA, 1999a) or TO-15 (U.S. EPA, 1999b) Methods will apply with sampling
modifications to accommodate canister samples or active/passive sorbent tubes. Analytical
instrumentation for Method TO-15 is comprised of the high-resolution gas chromatograph (GC)
coupled to a mass spectrometer (MS). This instrument can be operated in a continuously
scanning mode (SCAN mode) or a select-ion monitoring mode (SIM). Method TO-15 does not
provide the option for different detectors such as FID, ECD, PID, or a multi-detector
arrangement as specified in TO-14a. However, the GC/MS provides a more definitive
43
https://www.rivm.nl/bibliotheek/rapporten/601782002.pdf
https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0012
45
http://www.waterqualitydata.us/portal/
44
35
identification technique and with the SIM option, the lower detection limits can be achieved.
Sampling modifications include using summa stainless steel canister samples or to setting a solid
sorbent tube inside the chamber in a passive or active mode depending on the air flow setting.
Recommended sampling times are 0.5, 1, 3, 8, 12, and 24 hr integrated samples.
7. Indicate 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.
8. Indicate 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.
ii. Test Reports
In addition to the requirements provided by Unit VI, test reports submitted to the EPA are due 215 days
after effective date of the Order and must include the following, as applicable:
1. List of products to be tested that fit the product example and form, description of product,
total product quantity, and amount used for testing.
2. List of standards, how and when they were prepared, or/and purchased, and stored.
3. Calibration curve range and each point used - at least 5 points should be used for the
calibration curve.
4. All Quality Control (QC) samples described in suggested methods or selected method.
5. Chemical analysis queue containing standards, blanks, QC, samples in the order they were
analyzed, and date and time.
6. Specify methods used if different from recommendations. Similarly, provide details of
instruments, detectors, column description, and specifications if they differ from the
recommendations. Any deviations from the Test Protocols’ experimental set up, sampling,
extraction and analytical methods must be substantiated.
7. Chamber experiment specifications including but not limited to size, air flow, mobile phase,
temperature, and relative humidity.
iii. References
In addition to generally applicable references provided by Unit XI, the following is a list of references
specific to this testing requirement:
1. U.S. EPA (1999a). Method TO-14A: Determination of Volatile Organic Compounds (VOCs)
in Ambient Air Using Specially Prepared Canisters with Subsequent Analysis by Gas
Chromatography [EPA/625/R-96/010b], Compendium of Methods for the Determination of
Toxic Organic Compounds in Ambient Air, 2nd ed. Cincinnati, OH: U.S. Environmental
36
Protection Agency, Office of Research and Development, Center for Environmental Research
Information.
https://www.epa.gov/sites/default/files/2019-11/documents/to-14ar.pdf 46
2. U.S. EPA (1999b). Method TO-15: Determination of Volatile Organic Compounds (VOCs) in
Air Collected in Specially-Prepared Canisters and Analyzed by Gas Chromatography/Mass
Spectrometry (GC/MS) [EPA/625/R-96/010b], Compendium of Methods for the Determination
of Toxic Organic Compounds in Ambient Air, 2nd ed. Cincinnati, OH: U.S. Environmental
Protection Agency, Office of Research and Development ,Center for Environmental Research
Information. https://www.epa.gov/sites/default/files/2019-11/documents/to-15r.pdf 47
3. U.S. EPA (2017). Indoor Exposure Product Testing Protocols, Version 2.0 [740-S1-7002].
[Washington, DC]: U.S. Environmental Protection Agency, Office of Chemical Safety and
Pollution Prevention (OCSPP). https://www.epa.gov/sites/default/files/201801/documents/indoor_exposure_testing_protocols_version_2.pdf 48
46
https://www.epa.gov/sites/default/files/2019-11/documents/to-14ar.pdf
https://www.epa.gov/sites/default/files/2019-11/documents/to-15r.pdf
48
https://www.epa.gov/sites/default/files/2018-01/documents/indoor_exposure_testing_protocols_version_2.pdf
47
37
| File Type | application/pdf |
| File Title | EPA Letterhead Template - EPA ADMIN Signature |
| Author | Terry Green;[email protected] |
| File Modified | 2022-02-23 |
| File Created | 2022-02-23 |