Overview on Activities Involved in Issuing a TSCA Section 4 Order

The 2016 amendments to section 4 of TSCA provided EPA with the authority to issue test orders
(Orders), in addition to rules. Prior to issuing an order, the law requires that EPA make certain findings
and determine the appropriate testing to require, which is a complex and months-long process involving
many scientific and regulatory considerations. While issuing an Order is a more efficient process than a
multi-year notice and comment rulemaking, issuing an Order is a significant undertaking for the Agency.

EPA must ensure that the required determinations are made. Additionally, the Order must be developed
in a manner that identifies what information is required, what analyses were conducted that indicate
the need for the information, what testing will provide such information, and what methodologies or
other documents—such as OECD and/or OCSPP test guidelines—can inform the generation of such
information. Standard, globally-recognized test guidelines are often appropriate to inform certain data
needs, whereas other times, EPA may need to look elsewhere such as at New Approach Methods or
even develop new protocols that will enable the development of the needed data. Multiple technical
considerations go into determining testing requirements. Ultimately, EPA seeks to ensure that the
testing generates useful, high-quality data.

This document describes the steps EPA takes in preparing and issuing a TSCA section 4 Order. EPA
expects to expand and update this document as it gains experience in developing and issuing Orders.
This document does not cover the work entailed in administering Orders once they are issued (e.g.,
addressing questions from and meeting with Order recipients, providing technical clarifications,
reviewing study plan submissions, etc.).

Statutory Requirements and Determinations

TSCA section 4 authorizes EPA to order manufacturers and/or processors to conduct testing on
identified chemical substances (or mixtures). The findings EPA must make before it can exercise this
authority vary depending on which specific section 4 testing authority EPA is using, but the general
theme across these authorities is that EPA must determine with specificity what information it needs for
its decision-making, and must also meet certain statutory criteria as it requires the development of this
information:

•	TSCA section 4(a)(1) authorizes an Order where EPA finds that (1) the chemical substance may
present unreasonable risk or is produced in substantial quantities and may cause substantial or
significant exposures to the environment or humans, (2) there is insufficient information to
predict the effects of the chemical substance, and (3) testing is necessary to develop this
information.

•	TSCA section 4(a)(2) authorizes an Order to support certain activities undertaken pursuant to
specific provisions of TSCA and other federal laws. For example, EPA may issue an Order to
address a data need to support a risk evaluation undertaken pursuant to TSCA section 6. When
requiring the development of information pursuant to this provision, TSCA section 4(a)(3)
requires EPA to provide a "statement of need" that identifies, among other things, the need for
the new information and how information reasonably available to the Agency was used to
inform the decision to require new information.

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•	TSCA section 4(a)(4) states that EPA, "shall employ a tiered screening and testing process, under
which the results of screening-level tests or assessments of available information inform the
decision as to whether 1 or more additional tests are necessary." When EPA requires the
development of information under section 4, EPA must design a tiered-testing strategy (e.g.,
determine which screening-level tests would inform additional testing), unless EPA identifies
information that suggests advanced testing should be required. It typically takes EPA weeks to
months to complete these tasks, depending on the complexity of the tiered testing being
considered.

•	TSCA section 4(h), which is entitled "Reduction of testing on vertebrates", requires that EPA
reduce or replace the use of vertebrate animals to the extent practicable and scientifically
justified. EPA must not only consider reasonably available existing information prior to requiring
vertebrate testing, but must also encourage the use of scientifically valid test methods that
reduce or replace the use of vertebrate animals (provided that those methods will provide
information of equivalent or better scientific quality and relevance). If EPA requires vertebrate
testing in an Order issued under 4(a)(2), the Agency must explain why such testing is needed.
EPA is also encouraged under section 4(h)(2) to group chemicals into "scientifically appropriate
categories" to reduce testing on the substances within the category. These considerations
typically also take EPA weeks to months to address depending on the complexity of the methods
being considered.

In addition to the statutory requirements and determinations, before an Order can be issued, EPA must
also estimate the burden of an Order on the recipient(s). This step requires EPA to estimate the time
required for and cost of the testing it is ordering as well as the number of recipients subject to such
testing requirements. EPA may need to consult with testing laboratories to estimate the costs of specific
tests. This is because in addition to TSCA, EPA must also comply with the Paperwork Reduction Act (PRA)
by providing an Information Collection (IC), which summarizes the estimated burden for clearance of
each Order, to the Office of Management and Budget (OMB). Developing burden information can take
anywhere from weeks to months, and the OMB review process can also take a month or more, which
includes time for the internal processing steps required to submit an IC to OMB.

Addressing the statutory requirements typically takes at least several months. When added to the time
it typically takes to estimate the burden, identify Order recipients, and prepare for OMB review and
issuance of the Order, it is not uncommon for the entire process to require 6 months or longer. Many of
the statutory requirements interrelate in that EPA can work on them concurrently, and a high-level
description of such activities is described below in the Determining Testing Needs and Requirements
and Order Development Process sections of this document. Certain activities, such as estimating burden
and developing ICs, require EPA to first determine what testing is appropriate. EPA anticipates that it will
become more efficient in making findings to support Orders as it gains experience in using its Order
authority.

Determining Testing Needs and Requirements

To issue a TSCA section 4 Order, EPA must determine what information is needed as well as adhere to
the statutory requirements summarized above. The available information and understanding of
chemical substances varies. For instance, for some chemical substances (e.g., those that may have been
recently reviewed as new chemical pre-manufacture notices, or substances that have already been

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designated as high-priority substances for risk evaluation) EPA will already know a fair extent of what
hazard and exposure data are reasonably available, as well as how the chemical substance is used and
what exposure concerns might exist. However, for other chemical substances (e.g., most PFAS, the
thousands of chemical substances grandfathered onto the 1976 TSCA inventory that have not
subsequently undergone review, etc.), EPA will need to spend more time and resources determining
what information on the substance is reasonably available, which may include reviewing multiple
internal and external data resources. This work typically takes weeks to months depending on the
chemical. Ultimately, the consideration of reasonably available hazard and exposure data is a
fundamental process EPA undertakes prior to issuing an Order.

Once EPA has determined what information is required, it must consider what testing would produce
such information (see TSCA section 4(a)(1) and 4(a)(3)). EPA reviews whether available testing methods
and guidance—including OECD, OCSPP, or other standardized test guidelines—would produce the
needed information. If available testing methods to produce the needed information do not exist, test
protocols may need to be developed by EPA de novo. This review includes ensuring that testing pursuant
to an identified method or methods would produce consistent and scientifically relevant results for the
chemical substance. EPA staff working on the Order consult with experts throughout the Agency and, as
applicable, with experts outside EPA (e.g., the Occupational Safety and Health Administration). This
work often takes several months to complete. EPA anticipates that these consultations will decrease in
frequency and scope as it gains experience in identifying and assembling a library of applicable test
guidelines.

While standardized test methods typically provide general protocols to follow to ensure that the
conduct of the testing and reporting are appropriate, EPA may need to require additional metadata and
parameters that are essential to yield data that will ultimately be fit for its intended purpose.
Collaborating with technical experts inside and outside of EPA to define these metadata and parameters
may add weeks to months to Order development.

Order Development Process

EPA developed the procedures and infrastructure for developing TSCA Orders de novo since the law was
amended in 2016. The Agency is learning from and refining this process with feedback from internal
reviews and Order recipients. EPA expects that additional experience and feedback will continue to lead
to efficiencies and other improvements. With time, these steps should become more systematized, and
therefore quicker to complete.

Once EPA determines its specific testing needs, as described above, drafting the Order and determining
the burden associated with the Order can take an additional several months. EPA anticipates it will
complete the steps described below more quickly as it gains experience in using its Order authority.

One Order is often issued to multiple companies that manufacture and/or process the chemical
substance. EPA must identify these companies and their associated points of contacts. To do this, EPA
reviews EPA databases (e.g., the Chemical Information System (CIS) that stores TSCA data and the Toxics
Release Inventory (TRI), among other sources) and external sources (e.g., Safety Data Sheets) to identify
such manufacturers and/or processors. To improve the transparency of the process, EPA also tries to
address confidential business information (CBI) claims that prevent EPA from publicly connecting a
company to the chemical substance prior to issuing Orders. Based on EPA's experience to date, this

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process can take anywhere from a week to a month (or more) depending on how many companies are
identified and whether CBI claims that associate the company(ies) with the substance exist.

Once EPA identifies the recipients of the Order, the Agency uses EPA data, company websites, and other
resources to determine a Point of Contact (POC) for each company, who is authorized to receive service
on the company's behalf. The Agency then contacts the POCs to request that they confirm they are able
to represent their company for purposes of an Order or to help identify a different POC, as appropriate.
EPA also uses this communication to answer advance questions companies might have and help prepare
the companies ahead of the Order's issuance. This pre-issuance outreach the Agency now conducts as a
matter of course generally takes up to a few weeks to complete, depending on how many entities may
be subject to the Order.

EPA has recently developed TSCA section 4 Order templates. There is a template that details the process
for responding to the Order and other overarching topics related to the Order. EPA has been continually
refining this template as the Agency learns from past Orders, as well as in response to feedback
provided by stakeholders. EPA maintains additional templates that are used by the technical staff to
describe the testing needs and specify particular requirements for each identified testing need (e.g.,
compositions of chemical substance to test, test species, conditions of testing, etc.). These various
templates are then merged to create each specific Order. Because TSCA Section 4 provides unique
statutory requirements for issuing an Order depending on which specific basis for the Order is being
relied upon, EPA has developed unique template text associated with each of the TSCA section 4
provisions when using a given provision for the first time (see TSCA sections 4(a)(l)(A)(i), 4(a)(l)(A)(ii),
4(a)(2)(A), and 4(a)(2)(B)).

EPA's issuance of Orders has also necessitated improvements to its IT infrastructure to manage the
Orders and the information they generate. The Central Data Exchange (CDX) reporting application and
backend tools used to access information submitted via the CDX application are continuously refined to
support the receipt and management of information from hundreds of entities and facilitate transferring
the information into a workflow that is being developed and refined as it is simultaneously
implemented. Once an Order is signed, EPA enters the Order information into the reporting application
that recipients will use to respond to the Order, which generates a unique identifier that the recipient
will use when logging into the reporting application. EPA notifies each recipient's POC of the issued
Order, providing the unique identifier. Whenever EPA updates the template and/or response process
recipients will follow for a given Order, the Agency must make conforming edits to the CDX reporting
application before issuing the Order. Support for the IT infrastructure work currently relies on mostly
the same staff that develop and administer the Orders, given existing resources.

Finalizing an Order for Issuance

Once an Order is drafted, it undergoes a thorough review process that includes a legal review to ensure
that the Order meets applicable requirements, programmatic review to ensure that the Order provides
sufficient information for recipients to understand and respond to the Order, a technical review to
ensure that the requirements were incorporated correctly via the templating process and finally,
management review. These review processes often prompt additions or improvements to the Orders
(e.g., further clarifications to testing requirements), and can take a few weeks.

As described herein, creating an Order, starting with the templating process, determining and adding
the testing requirements and conducting all appropriate reviews takes at least six months, depending on

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how complicated the testing being required is as well as how unique the testing is (e.g., the extent to
which EPA needs to add information specific to the substance being tested to what a study protocol
requires in terms of the testing process or the test report that such testing will produce). As EPA accrues
experience in developing and issuing TSCA section 4 Orders, it is expected that development of future
Orders will become more efficient. Further, EPA expects to continue to learn from recipients of Orders
as to what could be improved in the template to help convey requirements of the Order and thereby
continue to improve and refine Order templates and the Order development process.

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