Possible Conditions of Use (COU) Tables for Di-isononyl Phthalate (DINP) Cas Numbers: 28553-12-0 and 68515-48-0 Chemical Data Reporting (cdr) Results

Possible Conditions of Use (CPU) Tables for Di-isononyl Phthalate (DINP)
CAS Numbers: 28553-12-0 and 68515-48-0
Chemical Data Reporting (CDR) Results
Section 6(b) of the Toxic Substances Control Act requires that the US Environmental Protection
Agency (EPA, or "the Agency") conduct risk evaluations on existing chemicals and identifies the
minimum components EPA must include in all chemical substance risk evaluations. 15 U.S.C.
2605(b). TSCA section 6(b) also allows manufacturers of a chemical to request an EPA-
conducted risk evaluation on the chemical. TSCA required EPA to develop the form and manner
under which these requests must be made, and the criteria for which EPA will determine whether
to grant a request. These requirements and criteria are set out in 40 CFR 702.37. Under 40 CFR
702.37(e)(3), EPA is required to assess whether the circumstances identified in a manufacturer
request for a risk evaluation constitute COUs (as defined under TSCA section (3)(4) and
implementing regulations (40 CFR 702.33)), and whether those COUs warrant inclusion within
the scope of a risk evaluation for the chemical substance. EPA must also assess what, if any,
additional conditions of use warrant inclusion within the scope of a risk evaluation for the
chemical substance. EPA will conduct these assessments based on the same considerations
applied in the same manner as it would for a risk evaluation for a high-priority substance.
The COUs in this document are a compilation of those identified by EPA from a review of recent
data submitted to EPA under the Chemical Data Reporting (CDR) rule in 2016 and constitute
possible additional COUs that may warrant inclusion in the scope of a risk evaluation. For a list
of uses of interest to the manufacturer, refer to the manufacturer request for a risk evaluation of
DINP in Docket ID No. EPA-HQ-OPPT-2018-0436. This list does not constitute all the uses that
may be evaluated in a risk evaluation for DINP.
As defined under the TSCA, COUs are "the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of." 15 U.S.C. § 2602(4).
EPA defines the approach it will use to identify the COUs in the Procedures for Chemical
Substance Risk Evaluation (40 CFR 702). While EPA interprets the circumstances that constitute
conditions of use as largely factual—i.e., EPA is to determine whether a chemical substance is
actually intended, known, or reasonably foreseen to be used in one or more of the activities listed
in the definition—considerations of the COUs will inevitably involve the exercise of some
discretion. As EPA interprets the statute, the Agency will exercise that discretion consistent with
the objective of conducting a technically sound, manageable risk evaluation to determine
whether a chemical substance - not just individual uses or activities - presents an unreasonable
risk to health or the environment. EPA will be guided by its best understanding, informed by
legislative text and history, of the circumstances of manufacture, processing, distribution in
commerce, use and disposal as Congress intended EPA to consider in conducting risk
evaluations.
1

-------
The statute grants some discretion to determine the circumstances that are appropriately
considered to be the chemical's COUs. In exercising that discretion, for example, EPA would not
generally consider that a single unsubstantiated or anecdotal statement (or even a few isolated
statements) on the internet that a chemical can be used for a particular purpose would necessitate
concluding that this represented part of the chemical substance's COUs.
As a further example, although the definition could be read literally to include all intentional
misuses (e.g., inhalant abuse), as a "known" or "reasonably foreseen" activity in some
circumstances, EPA interprets the risk evaluation process of TSCA section 6(b) as a focus on the
continuing flow of chemical substances from manufacture, processing and distribution in
commerce into the use and disposal stages of their lifecycle. EPA believes the statute is better
interpreted to focus on the prospective flow of the chemical substance, and therefore does not
consider legacy uses, or associated disposal as a COU. EPA will use the statutory definition and
EPA's approach described above to assess whether the circumstances identified in the
manufacturer request for a risk evaluation of DINP constitute COUs under 40 CFR 702.33, and
whether those COUs warrant inclusion within the scope of a risk evaluation for the chemical
substance, DINP. Subject to further analysis and public comment, EPA anticipates including
activities identified in the request as COUs in the risk evaluation of this chemical substance.
2

-------
CAS Number: 28553-12-0
T.ife Cycle Stage
C ategorv
Subcategory of Use
Source
\ hum fact urinu
Miinulactuiiim

i s i;i\\ coio)
1 in poili nu

i s i:i\\ (2Dlo)
Processing
Incorporation into
formulation, mixture, or
reaction product
Plasticizers
U.S. EPA (2016)
Process regulators
U.S. EPA (2016)
Adhesives and
sealant chemicals
U.S. EPA (2016)
Intermediates
U.S. EPA (2016)
Incorporation into article
Plasticizers
U.S. EPA (2016)
Processing as a reactant
Plasticizers
U.S. EPA (2016)
Repackaging
Paint additives and
coating additives not
described by other
categories
U.S. EPA (2016)
Distribution in
Coin nicivc :|''
Distribution in coninicivc

I S i;i\\ (2
-------

Intermediates
Mixed Metal
Stabilizer
U.S. EPA (2016)
Electrical and
electronic products
U.S. EPA (2016)
Toys, playground,
and sporting
equipment
U.S. EPA (2016)
Plastic and rubber
products not covered
elsewhere
U.S. EPA (2016)
Building/construction
materials not covered
elsewhere
U.S. EPA (2016)
Adhesives and sealant
chemicals
Paints and coatings
U.S. EPA (2016)
Adhesives and
sealants
U.S. EPA (2016)
Consumer uses
Plasticizers
Adhesives and
sealants
U.S. EPA (2016)
Building/construction
materials not covered
elsewhere
U.S. EPA (2016)
Electrical and
electronic products
U.S. EPA (2016)
Fabric, textile, and
leather products not
covered elsewhere
U.S. EPA (2016)
Furniture and
furnishings not
covered elsewhere
U.S. EPA (2016)
Personal care
products
U.S. EPA (2016)
Plastic and rubber
products not covered
elsewhere
U.S. EPA (2016)
Paint additives and
coating additives not
described by other
categories
Paints and coatings
U.S. EPA (2016)
Floor coverings
U.S. EPA (2016)
Electrical and
electronic products
U.S. EPA (2016)
Disposal ¦'
Disposal


a CDR includes information on the manufacturing, processing, and use of chemicals. CDR may not
provide information on other life-cycle phases such as distribution or chemical end-of-life after use in
products (i.e., disposal).
b EPA is particularly interested in information from the public on distribution in commerce.
4
-------
CAS Number: 68515-48-0
Life Cycle Stage
Category
Subcategory of Use
Source
Manufacturing
Manufacturing

U.S. EPA (2016)
Importing

U.S. EPA (2016)
Processing
Incorporation into
formulation, mixture, or
reaction product
Plasticizers
U.S. EPA (2016)
Plastic material and
resin manufacturing
U.S. EPA (2016)
Process regulators
U.S. EPA (2016)
Adhesives and sealant
chemicals
U.S. EPA (2016)
Intermediates
U.S. EPA (2016)
Incorporation into article
Plasticizers
U.S. EPA (2016)
Textiles, apparel, and
leather manufacturing
U.S. EPA (2016)
Electrical equipment,
appliance, and
component
manufacturing
U.S. EPA (2016)
Processing as a reactant
Plastic material and
resin manufacturing
U.S. EPA (2016)
Rubber product
manufacturing
U.S. EPA (2016)
Synthetic rubber
manufacturing
U.S. EPA (2016)
Distribution in
commerce ¦'''
Distribution in commerce

U.S. EPA (2016)
Commercial uses
Plasticizers
Fabric, textile, and
leather products not
covered elsewhere
U.S. EPA (2016)
Plastic and rubber
products not covered
elsewhere
U.S. EPA (2016)
Consumer uses
Plasticizers
Electrical and
electronic products
U.S. EPA (2016)
Fabric, textile, and
leather products not
covered elsewhere
U.S. EPA (2016)
Plastic and rubber
products not covered
elsewhere
U.S. EPA (2016)
5
-------
Disposal
Disposal


a CDR includes information on the manufacturing, processing, and use of chemicals. CDR may not
provide information on other life-cycle phases such as distribution or chemical end-of-life after use in
products (i.e., disposal).
b EPA is particularly interested in information from the public on distribution in commerce.
Reference
U.S. EPA (U.S. Environmental Protection Agency). (2016). Non-confidential 2016 Chemical
Data Reporting (CDR) Database, http://www.epa.gov/cdr/.
6
-------