Di-isononyl Phthalate (DINP); Manufacturer Request for Risk Evaluation Under
the Toxic Substances Control Act (TSCA)
Response to Comments
Docket Number: EPA-HQ-OPPT-2018-0436
December 2, 2019
Overview
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 conditions of use (as defined under TSCA
section (3)(4) and implementing regulations (40 CFR 702.33)), and whether those conditions of
use warrant inclusion within the scope of a risk evaluation for the chemical substance. EPA will
also assess what, if any, additional conditions of use warrant inclusion within the scope of a risk
evaluation for the chemical substance, and 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 in the EPA-initiated risk evaluation process. No later than 60 business days after
receiving a manufacturer request for risk evaluation that EPA has determined to be facially
complete (meeting the criteria set forth in 40 CFR 702.37(e)(1)), EPA is required to submit for
publication the receipt of the request in the Federal Register, open a public docket for the request
(which must contain the manufacturer request and EPA's possible additional conditions of use),
and provide no less than 45 calendar days for public comment.
This document includes EPA's responses to comments received during the public comment
period (August 19, 2019 to October 3, 2019) for docket number EPA-HQ-OPPT-2018-0436 (Di-
isononyl Phthalate (DINP); Manufacturer Request for Risk Evaluation Under the Toxic
Substances Control Act (TSCA)). During the public comment period, the public submitted
comments and information relevant to the requested risk evaluation.
The Agency received four public comments related to the manufacturer request for risk
evaluation for DINP. After careful review, the Agency determined that all of these comments are
substantively or procedurally relevant. All comments received are identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0436 and are available at
https://www.regulations.gov/document?D=EPA-HQ-OPPT-2018-0436-0003.
1. Comment submitting additional scientific research
A commenter (EPA-HQ-OPPT-2018-0435-0006) submitted six publications1 including
information about the negative developmental reproductive toxicity of DINP.
Response: The Federal Register Notice opening the public comment period requested the public
submit comments and information relevant to the requested risk evaluation, in particular the
identification of any information not included in the request that the commenters believe would
be needed to conduct a risk evaluation. The Agency will consider this study during the risk
evaluation of DINP.
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2.	Comment recommending that the Agency engage with a broad array of
stakeholders
A commenter (EPA-HQ-OPPT-2018-0435-008) suggested that EPA should engage a broad array
of downstream users in any discussion or negotiations relevant to decision-making on potential
regulatory actions, since moves by industry to replace chemicals pose significant burdens and
costs to the manufacturing cycle.
Response: The Agency engages and works with a variety of stakeholders throughout the risk
evaluation and risk management processes, including industry, federal, state, and local partners,
and academia, among others. Input from stakeholders is important in determining which
conditions of use are included in the scope of a risk evaluation; EPA also solicits public
comment on draft risk evaluations and engages in public peer review processes.
As required under TSCA section 6(b)(4), EPA conducts risk evaluations ". . . to determine
whether a chemical substance [or category of chemical substances] presents an unreasonable risk
of injury to health or the environment, without consideration of costs or other non-risk factors,
including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the
conditions of use." If EPA makes an unreasonable risk determination the Agency will move to
risk management.
TSCA section 6(c)(2) requires EPA to consider the reasonably ascertainable economic
consequences of a rulemaking (occurring during the risk management process), including: the
likely effect of a rule on the national economy, small business, technological innovation, the
environment, and public health; the costs and benefits of a proposed and final rule and of the one
or more primary alternative regulatory actions that EPA considered; and the cost effectiveness of
a proposed rule and of the one or more primary alternative regulatory actions that EPA
considered. Therefore, the burden and costs to the manufacturing cycle will be considered, as
appropriate, as part of the risk management of a chemical substance (or category of chemicals
substances).
3.	Comment noting a cumulative risk assessment of phthalates
A commenter (EPA-HQ-OPPT-2018-0435-0009) urged EPA to treat DINP (together with di-
isononyl phthalate (DIDP) and the five phthalates EPA proposed designate as high-priority
substances) as a "category" under TSCA, and to consider a cumulative risk assessment of all
seven phthalates.
Should EPA proceed in conducting a risk evaluation of DIDP and DINP, the commenter noted
that the Agency should include all known or reasonably foreseen conditions of use, as a failure to
do so will underestimate risk (especially to potentially exposed or susceptible sub-populations).
Additionally, the commenter noted that the Agency needs to determine the completeness of the
database search provided in the manufacturer request, suggesting that the reference list in the
request does not include all relevant information.
Response: This manufacturer request for evaluation was made specifically for DINP (CASRNs
28553-12-0 and 68515-48-0), not other chemicals or other phthalates. Since EPA's authority to
conduct a manufacturer-requested risk evaluation is tied to the "chemical substance . . . that a
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manufacturer of the chemical substance has requested . . ,_be subjected to a risk evaluation,"
(TSCA section 6(b)(4)(C)), EPA cannot add additional phthalates to the scope of the risk
evaluation, since this goes beyond the actual request for risk evaluation made by a manufacturer.
The provision of TSCA addressing aggregate exposures does not require EPA to conduct
cumulative risk evaluations; it requires EPA to describe whether aggregate or sentinel exposure
were considered, and the basis for that consideration. The Agency identified other phthalates for
prioritization on March 21, 2019 (including benzyl butyl phthalate (BBP), CASRN 85-68-7;
dibutyl phthalate (DBP), CASRN 84-74-2; dicyclohexyl phthalate (DCHP), CASRN 84-61-7;
di(2-ethylhexyl)phthalate (DEHP), CASRN 117-81-7; and diisobutyl phthalate (DIBP), CASRN
84-69-5), but these actions are separate from this request.
4. Comment asserting that the manufacturer request does not include all
relevant information under 702.37(b4)
A commenter (EPA-HQ-OPPT-2018-0435-010) asserted that the manufacturer request should
not have been found facially complete as it does not meet the regulatory requirement in
702.37(b)(4) that a request "include a list of all the existing information" relevant to the risk
evaluation. The comment suggests that the manufacturer only provided publicly available
information, and that other files and documents within the manufacturer's possession (or known
or reasonably ascertainable to them) were not submitted.
The commenter stated that the manufacturer request included the use of DINP in polyvinyl
chloride in children's toys as a condition of use, which is formally restricted and forbidden by
federal law, to undermine the Consumer Product Commission's (CPSC) prohibition.
The commenter also noted that relying on voluntary requests for information is limited, biased,
and/or leads to incomplete information, and that the Agency must identify any information gaps,
exercising regulatory authority under TSCA sections 8(c) and 8(d) to obtain "reasonably
available information."
Finally, the commenter indicated that they had filed a food additive petition with the Food and
Drug Administration (FDA) regarding ortho-phthalates. The commenter suggested that EPA
should consider the petition and its literature search when preparing a risk evaluation for DINP.
Response: While the commenter emphasized that the manufacturer did not "include a list of all
the existing information that is relevant to whether the chemical substance presents an
unreasonable risk of injury to health or the environment. . . ."(per 702.37(b)(4)), the submitting
manufacturers provided a signed certification (per requirements outlined under 702.37(b)(7)),
that all information in the request is accurate and complete, including the following:
I have either identified or am submitting all information in my possession, control, and a
description of all other data known to or reasonably ascertainable by me as required for
this request under this part. I am aware it is unlawful to knowingly submit incomplete,
false and/or misleading information in this request and there are significant criminal
penalties for such unlawful conduct, including the possibility of fine and imprisonment.
40 C.F.R. 702.37(b)(7)(C) (emphasis added)
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EPA does not have evidence to support the assertion by the commenter that the submitting
manufacturers for DINP did not submit all information in their possession, control, and a
description of all other data known to or reasonably ascertainable by them.
In addition to voluntary requests for information, EPA conducts literature searches and
stakeholder outreach during the risk evaluation process, to ensure that all reasonably available
information is considered during the risk evaluation. EPA recognizes the requirement to consider
"reasonably available information" when conducting risk evaluations ("information that EPA
possesses or can reasonably generate, obtain, and synthesize for use in risk evaluations,
considering the deadlines specified in TSCA section 6(b)(4)(G) for completing such
evaluation"). The Agency has determined that there is sufficient information (both submitted by
the manufacturer request and publicly available) to conduct a risk evaluation of DINP.
The Agency appreciates the information about the prior petition to FDA and will refer to the
petition and its literature search for ortho-phthalates (including DINP) during the risk evaluation.
5. Comment asserting that DINP should not include use in children's toys
A commenter (EPA-HQ-OPPT-2018-0435-010) asserted that the manufacturer request for DINP
asks EPA to include in its risk evaluation a use that is formally restricted and forbidden by
federal law. The commenter stated that the request "asks EPA to include as a "condition of use"
the use of DINP in polyvinyl chloride (PVC) "for children's toys and childcare articles," but this
use is already legally restricted by the CPSC."
Response: EPA appreciates this information and will consider this comment during the scoping
phase of the TSCA risk evaluation process for DINP.
1 Boberg, J., Christiansen, M.A., Kledal, T.S., Vinggaard, A.M., Dalgaard, M., Nellemann, C., Hass, U. (2011).
"Reproductive and Behaviorial Effects of diisononyl phthalate (DINP) in perinatally Exposed Rats."
Lioy, P.J., Hauser, R., Gennings, C., Koch, H.M., Mirkes, P.E., Schwetz, B.A., Kortenkamp, A. (2015, May 6).
"Assessment pf Phthalates/Phthalate Alternatives in Children's Toys and Childcare Articles: Review of the Report
Including Conclusions and Recommendation of the Chronic Hazard Advisory Panel of the Consumer Product Safety
Commission."
Furr, J.R., Lambright, C.S., Wilson, V.S., Foster, P.M., Gray, Jr, L.E. (2014, May 5). "A Short-term In Vivo Screen
Using Fetal Testosterone Production, a Key Event in the Phthalate Adverse Outcome Pathway, to Predict Disruption
of Sexual Differentiation."
Gray, Jr, L.E., Ostby, J, Furr, J., Price, M., Rao, Veeramachaneni, R.D.N., Parks, L. (2000, July 24). Perinatal
Exposure to the Phthalates EHP, BBP, and DINP, But Not DEP, DMP, or DOTP, Alters Sexual Differentiation of
the Male Rat."
Hannas, B.R., Lambright, C.S., Furr, J., Howdeshell, K.L., Wilson, V.S., Gray, L.E. (2011, June 1). "Dose-
Response Assessment of Fetal Testosterone Production and Gene Expression Levels in Rat Testes Following In
Utero Exposure to Diethylhexyl Phthalate, Diisobutyl Phthalate, Diisoheptyl Phthalate, and Diisononyl Phthalate."
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Hannas, B.R., Lambright, C.S., Furr, J., Evans, N., Foster, P.M.D., Gray, L.E., Wilson, V.S. (2011, November 22).
"Genomic Biomarkers of Phthalate-Induced Male Reproductive Developmental Toxicity: A Targeted RT-PCR
Array Approach for Defining Relative Potency."
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