[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Rules and Regulations]
[Pages 45089-45098]
[FR Doc No: 2023-14642]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2022-0262; FRL-2425.1-03-OCSPP]
RIN 2025-AA17

Addition of Diisononyl Phthalate Category; Community Right-to-
Know Toxic Chemical Release Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is adding a
diisononyl phthalate (DINP) category to the list of toxic chemicals
subject to the reporting requirements under the Emergency Planning and
Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act
(PPA). In this action, EPA is adding the DINP category to the toxic
chemical list as a category defined to include branched alkyl di-esters
of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a
total of nine carbons. The DINP category meets the EPCRA chronic human
health effects toxicity criterion because the members of the category
can reasonably be anticipated to cause serious or irreversible
reproductive dysfunctions as well as other serious or irreversible
chronic health effects in humans, specifically, developmental, kidney,
and liver toxicity.

DATES: The final rule is effective on September 12, 2023.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-TRI-2022-0262, is available at
https://www.regulations.gov. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Rachel Dean, Data Gathering and
Analysis Division (7406M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email:
[email protected].
    For general information contact: The Emergency Planning and
Community Right-to-Know Hotline; telephone numbers: toll free at (800)
424-9346 (select menu option 3) or<PHONE_NUMBER> in the Washington, DC
Area and International; or go to https://www.epa.gov/home/epa-hotlines.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you own or
operate a facility that manufactures, processes, or otherwise uses any
chemicals in the diisononyl phthalate (DINP) category. The following
list of North American Industrial Classification System (NAICS) codes
is not intended to be exhaustive, but rather provides a guide to help
readers determine whether this document applies to them. Facilities
subject to reporting under EPCRA section 313 include:
     Facilities included in the following NAICS manufacturing
codes (corresponding to Standard Industrial Classification (SIC) codes
20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324,
325*, 326*, 327*, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*,
113310, 211130*, 212323*, 212390*, 488390*, 512230*, 512250*, 5131*,
516210*, 519290*, 541713*, 541715* or 811490*. *Exceptions and/or
limitations exist for these NAICS codes.
     Facilities included in the following NAICS codes
(corresponding to SIC codes other than SIC codes 20 through 39):
211130* (corresponds to SIC code 1321, Natural Gas Liquids, and SIC
2819, Industrial Inorganic Chemicals, Not Elsewhere Classified); or
212114, 212115, 212220, 212230, 212290*; or 2211*, 221210*, 221330
(limited to facilities that combust coal and/or oil for the purpose of
generating power for distribution in commerce) (corresponds to SIC
codes 4911, 4931, and 4939, Electric Utilities); or 424690, 424710
(corresponds to SIC code 5171, Petroleum Bulk Terminals and Plants);
425120 (limited to facilities previously classified in SIC code 5169,
Chemicals and Allied Products, Not Elsewhere Classified); or 562112
(limited to facilities primarily engaged in solvent recovery services
on a contract or fee basis (previously classified under SIC code 7389,
Business Services, NEC)); or 562211*, 562212*, 562213*, 562219*, 562920
(limited to facilities regulated under the Resource Conservation and
Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) (corresponds to SIC
code 4953, Refuse Systems). *Exceptions and/or limitations exist for
these NAICS codes.
     Federal facilities.
     Facilities that the EPA Administrator has specifically
required to report to TRI pursuant to a determination under EPCRA
section 313(b)(2).
    A more detailed description of the types of facilities covered by
the NAICS codes subject to reporting under EPCRA section 313 can be
found at: https://www.epa.gov/toxics-release-inventory-tri-program/tri-covered-industry-sectors. To determine whether your facility would be
affected by this action, you should carefully examine the applicability
criteria in 40 CFR part 372, subpart B. If you have questions regarding
the applicability of this action to a particular entity, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    This action is issued under EPCRA sections 313(d), 313(e)(1) and
328, 42 U.S.C. 11023(d), 11023(e)(1) and 11048. EPCRA is also referred
to as Title III of the Superfund Amendments and Reauthorization Act of
1986.
    EPCRA section 313, 42 U.S.C. 11023, requires owners/operators of
certain facilities that manufacture, process, or otherwise use listed
toxic chemicals in amounts above reporting threshold levels to report
their facilities' environmental releases and other waste management
information on such chemicals annually. These facility owners/operators
must also report pollution prevention and recycling data for such
chemicals, pursuant to PPA section 6607, 42 U.S.C. 13106.
    Under EPCRA section 313(c), Congress established an initial list of
toxic chemicals subject to EPCRA toxic chemical reporting requirements
that was comprised of 308 individually listed chemicals and 20 chemical
categories.
    EPCRA section 313(d) authorizes EPA to add or delete chemicals from
the list and sets criteria for these actions. EPCRA section 313(d)(2)
states that EPA may add a chemical to the list if the Administrator
determines, in his judgment, that there is sufficient evidence to
establish that any of the listing criteria in EPCRA section 313(d)(2)
are met. Therefore, to add a chemical, EPA must determine that at least
one criterion is met, but need not determine whether any other
criterion is met. Conversely, to delete a chemical from the list, EPCRA
section 313(d)(3) dictates that EPA must determine that there is not
sufficient evidence to establish any of the criteria described in EPCRA
section 313(d)(2). The listing criteria in EPCRA section 313(d)(2)(A)-
(C) are as follows:
     The chemical is known to cause or can reasonably be
anticipated to cause significant adverse acute human health effects at
concentration levels that are reasonably likely to exist beyond
facility site boundaries as a result of

continuous, or frequently recurring, releases.
     The chemical is known to cause or can reasonably be
anticipated to cause in humans: cancer or teratogenic effects, or
serious or irreversible reproductive dysfunctions, neurological
disorders, heritable genetic mutations, or other chronic health
effects.
     The chemical is known to cause or can be reasonably
anticipated to cause, because of its toxicity, its toxicity and
persistence in the environment, or its toxicity and tendency to
bioaccumulate in the environment, a significant adverse effect on the
environment of sufficient seriousness, in the judgment of the
Administrator, to warrant reporting under this section.
    EPA often refers to the EPCRA section 313(d)(2)(A) criterion as the
``acute human health effects criterion;'' the EPCRA section
313(d)(2)(B) criterion as the ``chronic human health effects
criterion;'' and the EPCRA section 313(d)(2)(C) criterion as the
``environmental effects criterion.''
    Under EPCRA section 313(e)(1), any person may petition EPA to add
chemicals to or delete chemicals from the list. EPA issued a statement
of policy in the Federal Register of February 4, 1987 (52 FR 3479)
providing guidance regarding the recommended content of and format for
petitions. On May 23, 1991 (56 FR 23703), EPA issued guidance regarding
the recommended content of petitions to delete individual members of
the metal compounds categories reportable under EPCRA section 313. EPA
published in the Federal Register of November 30, 1994 (59 FR 61432)
(FRL-4922-2) a statement clarifying its interpretation of the EPCRA
section 313(d)(2) and (d)(3) criteria for modifying the EPCRA section
313 list of toxic chemicals.

C. What action is the Agency taking?

    In response to a petition, EPA is adding DINP as a category to the
list of toxic chemicals subject to the reporting requirements under
section 313 of EPCRA. As discussed in more detail later in this
document, EPA is concluding that the members of the DINP category meet
the EPCRA section 313(d)(2)(B) criterion for listing.
    Additionally, as indicated in the supplemental proposal and as is
now being finalized via this rulemaking, EPA is listing DINP as a
chemical category that includes all branched alkyl di-esters of 1,2
benzenedicarboxylic acid in which alkyl ester moieties contain a total
of nine carbons. This category includes but is not limited to the
chemicals covered by the CAS numbers and names identified by EPA at the
time of this rulemaking. In the supplemental proposal, EPA identified
the following chemicals: Diisononyl phthalate (CAS Number 28553-12-0),
Branched dinonyl phthalate (CAS Number 71549-78-5), Branched dinonyl
phthalate (CAS Number 14103-61-8), and Di(C8-10, C9 rich) branched
alkyl phthalate (CAS Number 68515-48-0). EPA has since identified that
Bis(7-methyloctyl) phthalate (CAS Number 20548-62-3) and Bis(3-
ethylheptan-2-yl) benzene-1,2-dicarboxylate (CAS Number 111983-10-9)
also meet the definition of DINP being used for this listing and thus
are also being included in the listing at 40 CFR 372.65(c) to assist
facilities in identifying members of the DINP chemical category.
    Further, in response to public comments and further review of
available information, EPA has updated the 2022 Technical Review of
DINP (Ref. 1) provided with the supplemental notice of proposed
rulemaking (87 FR 48128, August 8, 2022). The updated 2023 Technical
Review of DINP (Ref. 2) is in the docket for this rule. For the reasons
more fully explained in the updated 2023 Technical Review of DINP (Ref.
2), EPA is now listing the DINP category based on our conclusion that
it is reasonably anticipated to cause serious or irreversible
reproductive dysfunctions and other serious or irreversible chronic
health effects in humans, including developmental, kidney, and liver
toxicity. EPA has determined that the DINP can reasonably be
anticipated to cause serious or irreversible chronic human health
effects at moderately low to low doses and thus data show that DINP has
moderately high to high human health toxicity.
    As indicated previously, EPCRA section 313(d)(2) states that EPA
may add a chemical to the list if the Administrator determines, in his
judgment, that there is sufficient evidence to establish that any of
the listing criteria in EPCRA section 313(d)(2) are met. Therefore, to
add a chemical, EPA must determine that at least one criterion is met,
but need not determine whether any other criterion is met. Accordingly,
EPA is basing this addition on its conclusion that DINP is reasonably
anticipated to cause serious or irreversible reproductive dysfunctions
and other serious or irreversible chronic health effects in humans,
including developmental, kidney, and liver toxicity.
    Given multiple endpoint findings of serious or irreversible chronic
noncancer health effects, it was not necessary for the Agency to rely
on hazards related to cancer concerns as a basis for a TRI listing of a
DINP chemical category. The Agency is not, with this action, taking a
position as to whether or not DINP presents cancer concerns that would
support a TRI listing of the chemical category. In response to comments
received on the supplemental proposal, EPA has updated it hazard
analysis to include additional literature on cancer-related research on
DINP. However, EPA is forgoing further analysis of this particular
topic as it relates to the EPCRA 313 listing criteria. Given
forthcoming additional hazard analyses being conducted by the EPA
(e.g., pursuant to section 6 of the Toxic Substances Control Act) and
ensuring that the Agency has adequate resources to conduct its other
TRI activities, EPA has determined it appropriate to reduce the scope
of analysis for purposes of this listing.

D. Why is the Agency taking this action?

    EPA is taking this action in response to a petition submitted under
EPCRA section 313(e)(1) (Ref.3). In this case, EPA is granting the
petition to list DINP. Additional details about the petition are
included in the 2000 proposed rule and the 2022 supplemental proposed
rule (87 FR 48128, August 8, 2022).

E. What are the estimated incremental impacts of this action?

    EPA prepared an economic analysis for this action entitled,
``Economic Analysis for the Addition of Diisononyl Phthalate Category;
Community Right-to-Know Toxic Chemical Release Reporting'' (Ref. 4),
which presents an analysis of the costs of the addition of the DINP
category. EPA estimates that this action would result in an additional
198 to 396 reports being filed annually. EPA estimates that the costs
of this action will be approximately $968,546 to $1,935,041 in the
first year of reporting and approximately $461,212 to $921,448 in the
subsequent years. In addition, EPA has determined that of the 181 to
365 small businesses affected by this action, none are estimated to
incur annualized cost impacts of more than 1%. Thus, this action is not
expected to have a significant adverse economic impact on a substantial
number of small entities.

II. Summary of Proposed Rule

    On September 5, 2000 (65 FR 53681; FRL-6722-3), in response to a
petition filed under the EPCRA, EPA issued a proposed rule to add a
DINP category to the list of toxic chemicals subject to the reporting
requirements under EPCRA section 313 and PPA section 6607. EPA proposed
to add this chemical category

to the EPCRA section 313 toxic chemical list based on the Agency's
preliminary conclusion that this category met the EPCRA chronic human
health effects toxicity criterion. In response to comments on the
proposal, EPA revised its hazard assessment for DINP and issued a
notice of data availability (NODA) requesting comments on the revised
hazard assessment (70 FR 34437, June 14, 2005 (FRL-7532-4)). In the
NODA, EPA proposed to list DINP based on serious or irreversible
chronic health effects including liver, kidney, and developmental
toxicity but reserved judgment on whether cancer was an endpoint of
concern for DINP. On August 8, 2022 (87 FR 48128; FRL-2425.1-04-OCSPP),
EPA published a supplemental proposal, providing updated supporting
materials for the proposal (e.g., hazard assessment for DINP (i.e.,
2022 Technical Review of DINP) (Ref. 1)).

III. Summary of Comments Received and EPA Responses

    EPA received 15 comments on the supplemental proposed rule. Two
comments came from trade associations: the American Chemistry Council
(ACC) and the National Association of Chemical Distributors (NACD). Two
comments came from environmental/public interest groups: Earthjustice
(including Alaska Community Action on Toxics, Breast Cancer Prevention
Partners, Center for Environmental Health, Center for Food Safety,
Defend Our Health, Learning Disabilities Association of America, Sierra
Club) and Environmental Defense Fund (EDF). One comment also came from
an individual company: UPC Technology Corporation (UPC). Nine of the
on-topic comments came from both private citizens and an anonymous
commenter. There was also one off-topic anonymous comment. This unit
provides summaries of the most significant comments and EPA's
responses. A complete set of comments and EPA's detailed responses can
be found in the Response to Comments (RTC) document that is available
in the docket for this rulemaking (Ref. 5).

A. Comments Supporting EPA's Proposed Listing of DINP

    Earthjustice, EDF, and all private citizens and the anonymous
commenter expressed support for EPA's proposed addition of DINP to the
TRI list. Additionally, Earthjustice urged EPA to work quickly to
publish the rule as EPCRA does not require multiple toxicity endpoints
for listing.

B. Comments on the Listing Standard

    Comment: UPC disagreed with EPA's proposed listing. UPC claimed
that adding DINP to the TRI chemicals list will cause companies to
shift away from DINP, instead dealing with chemicals which have not
been as well reviewed as DINP, and might be more toxic than DINP, and
that listing DINP would create a barrier to international trade. They
cited European Chemicals Agency 's (ECHA's) 2018 decision not to label
DINP as a hazardous chemical as justification for why DINP would not
satisfy EPCRA's requirements for listing.
    EPA response: EPA respectfully disagrees with the commenter that
DINP does not meet the TRI chemical listing criteria specified in EPCRA
section 313(d)(2). Additionally, the fact that a chemical is not on a
given organization's ``hazardous chemical'' list does not mean that the
chemical fails to meet the EPCRA section 313(d)(2) listing criteria.
The Agency's full rationale for listing the DINP category is detailed
in the 2023 Technical Review of DINP (Ref. 2) and Response to Comments
(Ref. 5).
    Comment: ACC also disagreed with EPA's proposed listing of DINP.
They asserted that EPA did not apply the correct legal standard because
the Agency did not list DINP based on ``cancer, birth defects, or
serious or irreversible reproductive dysfunctions, neurological
disorders, or heritable genetic mutations.'' ACC also asserts that EPA
improperly put the onus on the commenters to prove that DINP is not
adverse to humans, rather than EPA showing that it is adverse to
humans; and that EPA is assuming or ``suspects'' that DINP is a hazard,
rather than having sufficient information that it does, in fact, meet
the listing criteria.
    EPA response: Section 313(d)(2) of EPCRA sets out the legal
standard for adding new chemicals to the TRI list, and EPA applied this
standard when deciding to add DINP. Commenters incorrectly describe
this standard, which allows for listing based on sufficient evidence to
establish any one of several criteria, including that the chemical is
known to cause or can reasonably be anticipated to cause in humans
``cancer or teratogenic effects, or serious or irreversible
reproductive dysfunctions, neurological disorders, heritable genetic
mutations, or other chronic health effects''. The Agency reasonably
relied on hazards identified from animal studies which could plausibly
be extrapolated to humans based on a weight of evidence (WoE)
evaluation of health hazards posed by DINP in determining that DINP can
reasonably be anticipated to cause one or more serious or irreversible
chronic health effects in humans.
    As documented in the 2023 Technical Review of DINP (Ref. 2), the
evidence available to EPA is sufficient to establish that DINP can
reasonably be anticipated to cause in humans serious or irreversible
reproductive dysfunctions as well as other serious or irreversible
chronic health effects in humans, specifically, developmental, kidney,
and liver toxicity. This evidence includes evidence of developmental
toxicity, such as: reduced pup weights, skeletal variations, and
dilated renal pelvises; and also evidence of reproductive dysfunctions
such that ``gestational exposure to DINP has been shown to induce
effects consistent with the spectrum of effects such as reduced fetal
testicular testosterone, decreased AGD, increased male pup nipple
retention, altered reproductive organ weight, testicular pathology, and
a low incidence of reproductive tract malformation in some studies
(such effects are sometimes generally referred to as `phthalate
syndrome').'' (Ref. 2). This evidence also includes evidence of other
serious or irreversible chronic health effects; specifically, non-
cancer liver and kidney toxicity.
    Comment: ACC points to studies in non-human primates to argue that
primates are much less sensitive to DINP than are rodents. ACC argues
that the timeline of the primate studies was similar to that of rodent
studies, so they should be considered.
    EPA response: The commenter's argument does not consider the
explanation that the short study duration (especially relative to the
lifespan of the test species) accounts for the lack of treatment-
related effects, and instead attributes the differential toxicity to
differences in species sensitivity. ACC was referring to a 14-day study
in macaques (Ref. 6) and a 90-day study in marmosets (Ref. 7). The
marmoset study did show decreases in body weights and body weight gains
in both sexes. However, the non-human primate studies were not further
evaluated due to being considered insufficient in study design and
duration to evaluate DINP for carcinogenicity as well as for potential
reproductive and developmental effects.

C. Comments Related to Hazard: Cancer

    Comment: ACC commented on EPA's proposal to list DINP based on
cancer as an endpoint, and stated that the EPA could not list DINP on
the TRI simply because it was on the California Prop 65 list. ACC
further commented that certain animal tumors discussed in the

2022 Technical Review of DINP (Ref. 1) as evidence for listing DINP due
to carcinogenicity (including alpha-2u-globulin-mediated kidney cancers
in male rats, mononuclear cell leukemia (MNCL), and PPAR[alpha]-
mediated liver tumors) are not indicative of human hazard. The comment
claimed that there is significant evidence to show that all three DINP-
induced rodent tumors are specific to rodents and not relevant to human
cancer.
    EPA response: EPA's decision to list DINP on the TRI is based on
EPA's analysis of the available data, and not, as the commenter appears
to suggest, on a decision made by another regulatory body. Moreover, as
explained in greater detail in the Response to Comments (Ref. 5), EPA
has decided not to rely on a cancer endpoint for this action to add a
DINP chemical category to the TRI chemical list.
    As explained in greater detail in the 2023 Technical Review of DINP
(Ref. 2), in this action EPA is adding DINP to the TRI chemical list
based on toxicity data demonstrating that these chemicals can be
reasonably anticipated to cause serious or irreversible reproductive
dysfunctions and other serious or irreversible chronic human health
effects, including developmental, liver, and kidney effects. EPA
revised the 2022 Technical Review of DINP (Ref. 1) regarding the
evaluation of MNCL and tumors in the liver and kidney, in addition to
including a new section on ``Tumors Observed in Other Organs'' under
the Conclusions on Carcinogenicity Section of the 2023 Technical Review
of DINP (Ref. 2). This section provides a brief discussion of the data
for pancreatic islet cell carcinomas, testicular interstitial (Leydig)
cell carcinomas and uterine adenocarcinomas. EPA did not, however, base
its decision to list DINP on these data.

D. Comments Related to Hazard: Reproductive Dysfunctions and
Developmental Toxicity

    Comment: ACC asserted that, ``in addition to animal evidence, human
evidence, where available, would be crucial to the EPA's evaluation,
including the developmental endpoint for DINP. However, neither the
EPA's Supplemental Notice nor the Revised Technical Review for DINP
includes any of the growing epidemiological evidence''.
    EPA response: The Agency acknowledges that the evidence of
developmental hazard presented to support the listing of DINP on the
TRI focused on the evidence in developmental toxicity and reproduction
studies in laboratory animals. The Agency determined that this evidence
is extensive and unambiguous in interpretation. EPA notes that the
epidemiology data on developmental hazard, although pertinent, do not
negate the importance of the animal data, especially given the extent
of evidence provided by animal data. Further, inconsistent results make
it difficult to draw a definitive conclusion on hazard concerns from
epidemiological data on DINP. Therefore, EPA determined that the
epidemiological studies are not required to inform the Agency's
decision to list DINP on the TRI. EPA's discussion of the
epidemiological data referenced by ACC in its comment is addressed
further in the Response to Comment document (Ref. 5). Furthermore, the
Agency does not consider the lack of presentation of epidemiological
evidence to detract from the strength of evidence of both developmental
and reproductive hazard posed by DINP represented in the animal
studies.
    Comment: Reduced pup weights were reversible or transient,
inconsistently observed, not statistically significant, and did not
cause any adverse effects in older rats, so they should not be
considered ``serious or irreversible'' effects.
    EPA response: EPA disagrees with the characterization of the body
weight decreases as transient, which is typically interpreted in
evaluation of toxicology studies as the effect being temporary in the
presence of continued exposure. In the two major studies cited (both
discussed in Waterman et al., 2000 (Ref. 8)), statistical significance
was achieved at multiple timepoints. Particularly in the two-generation
study (Ref. 8), the decreased F1 offspring body weights became more
pronounced in statistical significance and in magnitude difference from
controls, and occurred at lower doses as the post-natal period
proceeded. The effects of DINP on body weight occurred in both sexes
and across generations and generally increased in significance and
magnitude with time; and importantly, occurred at lower doses in
offspring compared to parents.
    Regarding ACC's comment that reduced pup weight results are
inconsistent, EPA acknowledges that in some studies with shorter
exposure durations, longer term effects on growth may not be apparent.
In the study by Clewell et al. (Ref. 9), pregnant rats were
administered DINP in the diet from gestational day (GD) 12 through
postnatal day (PND) 14. However, even with this shorter exposure
duration, dams exhibited reduced body weight, body weight gain, and
food consumption during gestation and lactation at 750 mg/kg/day.
Offspring body weights of males were decreased at PND 14 at the high
dose on PND 2 ([darr]12%) and dose-dependently at both the mid- and
high-dose on PND 14 ([darr]10-27%) at termination of dosing. The fact
that the male offspring body weights were not significantly decreased
by PND 49-50 ([darr]4%; NS) with no exposure to DINP since PND 14 (~35
days) does not equate to transient decreases (those that occur with
continued exposure).
    Furthermore, an additional study showed that decreased body weights
persisted after the treated period ended. Masutomi et al. (Ref. 10)
evaluated developmental effects in the offspring of female Sprague-
Dawley rats exposed to DINP in the diet at concentrations of 0, 400,
4,000, or 20,000 ppm from GD 15 to PND 10. Even though treatment ceased
on PND 10, prepubertal body weights of offspring were still
significantly decreased on PND 27. Importantly, the decreased body
weight in male offspring occurred at a lower dose than affected
maternal body weights, indicating heightened relative sensitivity of
male offspring exposed in utero compared to parents. Finally, it is
important to note that these decreases were substantial, with decreases
of 18% in mid-dose males and 39-47% in high dose males and females, and
were highly significant (p<0.01). This supporting evidence shows that
adverse effects are seen in prepubertal rats born to exposed pregnant
females; it can be reasonably expected that results would persist into
adulthood.
    In short, the decreases in body weight and weight gain in the
animals in the reproduction and developmental toxicity studies on DINP
are ``serious,'' in part, because they increase in magnitude and
significance with time exposed and across generations and occur at
lower doses in offspring than in parents.
    Comment: ACC questioned EPA's use of skeletal effects and dilated
renal pelvises as evidence of DINP toxicity to developmental health.
ACC stated that the conclusions of the ECHA and Australia's National
Industrial Chemicals Notification and Assessment Scheme (NICNAS) are
that supernumerary ribs are common anomalies in rodents which can only
be ``indicative of slight developmental effects.'' ACC asserted that
animals in multi-generation studies thrived and there was no evidence
of adverse effects related to these variations. ACC also asserted that
the agency itself is unsure of the biological relevance of increased

rib variations in rats. For the renal pelvises effects, ACC stated that
the dilated renal pelvises reported in Waterman et al. (2000) (Ref. 8)
and Hellwig et al. (1997) (Ref. 11) are transient, of doubtful
biological and statistical significance, and occur only at maternally
toxic doses.
    EPA response: Supernumerary ribs are larger (longer) structures
with distal cartilage present and are likely to be permanent,
ultimately remaining as distinct ribs; whereas ossification sites are
smaller (shorter) structures without distal cartilage and are likely to
be transient.
    The developmental variations seen in Waterman et al. (1999) (Ref.
12) include significantly increased incidences of rudimentary lumbar
ribs at 500 and 1,000 mg/kg-day, compared to controls. Additionally,
incidences of supernumerary cervical ribs were significantly increased
at 1000 mg/kg-day, compared to controls. The authors noted that
supernumerary lumbar ribs ``have been associated with nonspecific
maternal toxicity''; however, this does not preclude its relevance, and
it is important to note that significantly increased incidences of
rudimentary lumbar ribs were noted at a dose lower than that at which
maternal toxicity was observed. Furthermore, no corroborating findings
of delayed fetal ossification, which would suggest that fetal effects
were secondary to maternal effects, were reported at the high dose in
this study. ACC has taken the Agency's statement from the 2022
Technical Review of DINP (Ref. 1) out of context. The full statement
was: ``Therefore, although the biological significance of a
statistically significant increase in rib variations is uncertain, the
Agency believes that the dose-related response observed in the Waterman
et al. (1999) (Ref. 12) study may represent growth alterations that are
indicative of DINP's potential to disrupt normal developmental patterns
and produce a developmental hazard.'' The Agency reiterates its
conclusion that DINP can reasonably be anticipated to be
developmentally toxic to humans.
    EPA acknowledges that the dilated renal pelvises observed in
Hellwig et al. (1997) (Ref. 11) were consistently increased over
controls only at the high dose of 1000 mg/kg-day. However, the fact
that this fetal finding in this study was noted at a dose that was
toxic to the maternal animals does not preclude its toxicological
relevance to offspring. And it is important to note that, for DINP-3,
increased dilated renal pelvises observed at 1000 mg/kg-day were
accompanied in some instances by renal malformations (e.g.,
hydroureter, agenesis or absence of kidney). Furthermore, in the
developmental toxicity study in rats conducted by Waterman et al.
(1999) (Ref. 12), fetal and litter incidences of dilated renal pelvis
were statistically significant and dose-dependently increased in all
treated groups, whereas maternal toxicity, as evidenced by decreased
body weights and weight gains during treatment, was affected only at
the high dose of 1000 mg/kg-day. EPA disagrees with the
characterization that dilated renal pelvis is a ``normal developmental
phenomenon'' (as stated by NICNAS), but acknowledges that the
toxicological relevance is dependent upon the incidence and severity.
Nevertheless, the commenters mischaracterized NICNAS's conclusion on
these variations. The full statement from NICNAS reads: ``These
variations are relatively common in rodents; however, the induced
frequencies (78% vs 25% control for rudimentary lumbar ribs, and 26% vs
0% control for dilated renal pelvises) were outside historical control
ranges and thus interpreted as indicative of slight developmental
effects.'' (Ref. 13, emphases added). Therefore, NICNAS also
interpreted the renal pelvis and additional lumbar ribs to be
indicative of adverse effects of DINP.
    To summarize, dilated renal pelvises incidences in these studies
are treatment-related, and it remains to be seen whether the findings
are reversible/transient because that depends on the severity of the
effects. However, it is the Agency's determination that dilated renal
pelvises, in addition to renal malformations, even at doses with
observed maternal toxicity, are biologically significant, and
contribute to the WoE for DINP as a developmental toxicant.
    Comment: ACC asserted that DINP does not cause a serious or
irreversible effect on anogenital distance (AGD) or nipple retention in
animals, citing a lack of statistical significance in Clewell et al.
(2013) (Ref. 14) for AGD and Gray et al. (2000) (Ref. 15) for nipple
retention. ACC stated that these effects, if they occur, are only
transient and do not persist into adulthood. Finally, ACC asserts that
DINP is not associated with male reproductive malformations in humans.
    EPA response: EPA acknowledges that there is some inconsistency in
reporting of significant effects on AGD across available studies of
DINP and that permanent, statistically significant reductions in AGD
have not been reported in adult offspring following gestational
exposure to DINP. However, reduced AGD in males is only one of many
effects that make up phthalate syndrome (or androgen insufficiency
syndrome). As described in EPA's 2023 Technical Review of DINP (Ref.
2), gestational exposure to DINP has been shown to induce effects
consistent with the spectrum of effects that comprise phthalate
syndrome (e.g., reduced fetal testicular testosterone, decreased AGD,
increased male pup nipple retention, altered reproductive organ weight,
testicular pathology, and a low incidence of reproductive tract
malformation in some studies). Therefore, EPA still considers a
decrease in AGD to be a potential adverse and serious outcome of DINP
exposure and a reflection of the suite of effects that comprise
phthalate syndrome.
    EPA also acknowledges that there is some inconsistency in reporting
of nipple retention across available studies of DINP. In Gray et al.
(2000) (Ref. 15), the finding of permanent nipples in DINP-treated rats
was accompanied by several abnormalities in the testes, including
testicular atrophy, epididymal agenesis with hypospermatogenesis, and
scrotal fluid-filled testis devoid of spermatids. This syndrome may
result from inhibition of fetal testis hormone production during sexual
differentiation, a process that is critical in all mammals including
humans. Furthermore, the finding of nipple retention was not
exclusively noted in Gray et al. (2000) (Ref. 15). For example, Boberg
et al. (2011) (Ref. 16) demonstrated a dose-dependent and statistically
significant increase in the number of retained nipples in DINP-exposed
(GD 7 to PND 19) male pups on PND 13 at 750 mg/kg-day (3.14) and 900
mg/kg-day (3.17) compared to controls (1.98), which ACC failed to
mention when citing the findings in the study at PND 90.
    In addition to the male reproductive malformations noted in the two
studies by Gray et al. (2000 (Ref. 15), 2023 (Ref. 17)), EPA discussed
the findings of ten additional studies in its 2023 Technical Review of
DINP (Ref. 2) which support the WoE for serious adverse impacts on the
male reproductive tract. Such effects include: decreased body weight at
the onset of puberty; decreased weights of the testes, levator ani plus
bulbocavernosus muscles (LABC), and seminal vesicles; decreased
testosterone, percent motile sperm, and AGD; increased incidences of
multinucleated gonocytes (MNGs) in testes, large Leydig cell
aggregates, degeneration of stage XIV meiotic spermatocytes, vacuolar
degeneration of Sertoli cells, and scattered cell debris in the
epididymal ducts; and effects on male copulatory

behavior (reduced number of mounts, intromissions, and ejaculations).
    Phthalate syndrome may result from inhibition of fetal testis
hormone production during sexual differentiation, a process that is
critical in all mammals including humans. EPA concludes that humans can
reasonably be anticipated to be affected if exposed to sufficient
concentrations of DINP or its metabolites at critical stages of
reproductive development.

E. Comments Related to Hazard: Liver Toxicity

    Comment: ACC commented on EPA's identification of spongiosis
hepatis as a treatment-related lesion in rats exposed to DINP, and the
Agency's position that the occurrence is relevant to human health; more
specifically, ACC asserted that the mere fact that a lesion is
treatment-related in a rat does not mean it will occur in humans. ACC
further stated that the effect did not occur in mice exposed to similar
levels of DINP, and that it is not a serious or irreversible effect,
even in rats, because EPA did not state whether spongiosis hepatis is
linked to any other adverse pathological or toxicological process
detrimental to the health of affected rats. ACC added that liver enzyme
changes in studies appeared to be sporadic and not indicative of
serious liver damage. ACC concluded that spongiosis hepatis is not
relevant to human health.
    Response: EPA disagrees with ACC's conclusion and maintains that
the finding of spongiosis hepatis in rats has human relevance as one of
multiple indicators of adverse outcomes to the liver post-DINP
exposure. While the human relevance of spongiosis hepatis, in
particular, is unclear, that does not preclude its relevance in a WoE
evaluation of evidence of hepatotoxicity in the rat, and the Agency
does not consider the lack of evidence of a direct human correlate of
spongiosis hepatis to detract from the extrapolation of that evidence
in animals to relevance to human health. The Agency references Lington
et al. (1997) (Ref. 18) for the co-occurring findings of other
histopathology effects in the liver due to DINP treatment including
focal necrosis, hepatopathy associated with leukemia, and
hepatocellular enlargement in both sexes, in addition to sinusoid
ectasia in males. The Agency also references Moore et al. (1998a) (Ref.
19) and Bio/dynamics (1987) (Ref. 20) for co-occurring findings in the
liver, including cytoplasmic eosinophilia, diffuse hepatocellular
enlargement, and increased pigment in both sexes, and additionally
individual cell degeneration/necrosis in the males. Moore et al.
(1998b) (Ref. 21) also conducted a 2-year study in mice and found
similar adverse treatment-related effects on the liver. In all these
studies, increases in key indicator enzymes were also observed.
    The Agency acknowledges that treatment-related effects on the liver
are often along a continuum, with effects early on and at lower doses
reflecting an adaptive response (often indicated by increased liver
weights and/or hepatocellular hypertrophy) but progressing to an
adverse response at prolonged or higher doses, characterized by adverse
findings in clinical chemistry and histopathology. While induction of
CYP450s as a metabolic activation response of the liver may be an
adaptive response, increases in ALT are indicative of liver damage and
inherently adverse, and the clinical interpretation of this finding is
conserved across species, including humans. For certain enzymes (e.g.,
ALT), increases, as well as various enzymatic activities when
considered with other effects such as histopathology lesions, are
adverse effects and support the conclusion that DINP induces serious
chronic effects in the liver beyond liver enlargement. Thus, the Agency
disagrees with ACC's assertion that the increases in liver weights and
enzymes seen in these studies are an adaptive response or are non-
serious in the total weight of evidence.

F. Comments Related to Hazard: Kidney Toxicity

    Comment: ACC commented that: (a) DINP does not cause and cannot
reasonably be anticipated to cause rodent chronic progressive
nephropathy (CPN) in human kidneys, as no human analog exists; (b)
while EPA may ``speculate,'' per ACC's characterization, that chemicals
that cause CPN in rodents may cause other kidney effects in humans,
such ``speculation'' is not appropriate for a TRI listing; and (c) even
the EPA's ``speculation'' is unlikely to be supported, as there is
minimal evidence that DINP is associated with any kidney disease in
humans. ACC further points to the lack of adverse effects seen in
primate studies as evidence that DINP is not relevant to human health.
    EPA response: Although the mechanism of DINP-induced kidney
toxicity may not be clear, the kidneys are clearly a target of DINP-
induced toxicity which can reasonably be anticipated to cause serious
or irreversible chronic health effects in humans, as evidenced by
increases in absolute and relative kidney weights, clinical chemistry
(e.g., increased blood urea nitrogen), urinalysis changes, and findings
in gross pathology (e.g., granular pitted/rough kidneys), and
histopathology (e.g., reduction in the tubular space and oedema of
epithelial cells in the glomeruli, a loss of loop points in the
glomerular capillaries, increased granular casts and regenerative/
basophilic tubules) in rats and mice. EPA disagrees with ACC's
conclusion that the changes in kidney weights in rats are not relevant
to human kidney toxicity, and asserts that the lack of an effect in the
primate studies ACC mentioned is plausibly related to the shorter
duration of dosing relative to the life span of the animal instead of
indicating a lack of relevance to humans. (See the ``Generally: EPA has
Failed to Apply the Correct Legal Standard in this Case'' section.)
Given that increased kidney weight appears as a consistent effect among
other kidney injuries following DINP exposure, EPA believes it to be
relevant in the WoE supporting DINP kidney toxicity. EPA acknowledges
that, in a letter to the U.S. EPA IRIS Program (NIEHS 2019) (Ref. 22),
U.S. NTP concluded that the ``morphological spectrum of CPN have no
analog in the human kidney and that CPN is distinct entity in the rat
(Hard et al., 2009) (Ref. 23).'' However, NTP also acknowledged that
``The etiology of CPN is unknown and represents a complex disease
process in rats. Given the fact that there is no definitive
pathogenesis for this multifactorial disease process, it cannot be
fully ruled out that chemicals which exacerbate CPN in rats may have
the potential to exacerbate disease processes in the human kidney.''
Subsequently, the EPA IRIS Program in its toxicological reviews of
tert-Butanol (EPA 2021a) (Ref. 24) and ethyl tertiary butyl ether (EPA
2021b) (Ref. 25) (chemicals which cause CPN in male and female rats)
concluded that ``a chemical that exacerbates CPN in rats could also
exacerbate disease processes in the human kidney'' and that other
effects in the kidney were observed that were not confounded by alpha
2u-globulin related processes, and kidney toxicity was selected as the
basis of the oral noncancer reference doses that were derived.
Similarly, for DINP, available studies demonstrate a spectrum of
effects on the kidney. Given the WoE when considering the other effects
involving the kidney, and EPA's position, based on the Agency's
technical expertise, that chemicals which exacerbate CPN in rodents
could also exacerbate disease processes in the human kidney, DINP can
reasonably be anticipated to cause serious and/or

irreversible harm to the kidney based on the literature reviewed.
    Furthermore, the EPA disagrees with ACC's assertion that the kidney
toxicity seen in female mice is irrelevant to human health. Although
[alpha]-2u-globulin MOA is male rat-specific and has been shown not to
be relevant to humans, the MOA for kidney toxicity for female rats and
male and female mice remains unclear and so in order to be protective
of human health, EPA maintains that CPN is relevant to human health and
contributes to the WoE for kidney toxicity for this non-cancer
endpoint. A study by Ma et al. (Ref. 26) found that oxidative stress
may be involved in the hepatic and renal toxicities associated with
DINP exposure. In order to be protective of human health, the EPA
maintains that oxidative stress-related mechanism are relevant to human
health. EPA would like to direct ACC's attention to the ``Conclusions
on Chronic Non-cancer Toxicity'' section <IP_ADDRESS> on ``Kidney Effects''
in the 2023 Technical Review of DINP (Ref. 2) for further details.

G. Comments Related to Exposure

    Comment: ACC argued that due to its physico/chemical properties,
community exposure to DINP via environmental release is negligible.
    EPA response: As EPA has previously stated, including in the
supplemental proposal for this rulemaking (87 FR 48128), it is not
appropriate to consider exposure for chemicals that are moderately high
to highly toxic based on a hazard assessment when determining if a
chemical should be added for chronic human health effects pursuant to
EPCRA section 313(d)(2)(B) (see 59 FR 61440-61442). EPA concludes that
DINP can reasonably be anticipated to cause serious or irreversible
chronic human health effects at moderately low to low doses including
serious or irreversible reproductive dysfunctions as well as other
serious or irreversible chronic health effects in humans, specifically,
developmental, kidney, and liver toxicity. The data for DINP
demonstrates that DINP has moderately high to high human health
toxicity. For listings pursuant to EPCRA section 313(d)(2)(A), EPA must
consider whether ``chemical is known to cause or can reasonably be
anticipated to cause significant adverse acute human health effects at
concentration levels that are reasonably likely to exist beyond
facility site boundaries as a result of continuous, or frequently
recurring, releases.'' However, even pursuant to such listings, the
Agency need not confirm that communities are actually exposed to the
given chemical, but rather that concentration levels of concern are
reasonably likely to exist beyond a facility's boundaries as a result
of releases. Further, listings based on EPCRA section 313(d)(2)(B) (as
well as EPCRA section 313(d)(2)(C)) do not require an exposure
assessment, but rather are based on hazard alone.
    Therefore, in accordance with EPA's standard policy on the use of
exposure assessments (see November 30, 1994 (59 FR 61432, FRL-4922-2),
an exposure assessment is neither necessary nor appropriate for
determining whether DINP meets the criteria of EPCRA section
313(d)(2)(B).
    Additionally, EPA notes that EPCRA indicates that TRI reporting
forms are intended to provide information to governments and the public
to inform persons about releases of toxic chemicals to the environment,
assist in the conduct of research and data gathering, and to aid in the
development of regulations and other similar purposes (see EPCRA
section 313(h)). Accordingly, even if releases are very small, the data
reported is still useful. For example, such reporting might indicate
that a toxic chemical being used in the community is not being released
at levels of concern, which would be reassuring to residents. Further,
how the public or any particular entity may make use of TRI data on a
particular chemical need not factor into whether or not that chemical
is on the TRI list of chemicals.

IV. Summary of the Final Rule

    EPA is finalizing the addition of a DINP category to the EPCRA
section 313 list of toxic chemicals. Based on EPA's review of the
available toxicity data, EPA has determined that these chemicals can be
reasonably anticipated to cause serious or irreversible reproductive
dysfunctions as well as serious or irreversible chronic human health
effects in humans, including developmental, kidney, and liver toxicity.
Therefore, EPA has determined that the evidence is sufficient for
listing the DINP category on the EPCRA section 313 toxic chemicals list
pursuant to EPCRA section 313(d)(2)(B).

V. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. USEPA. Technical Review of Diisononyl Phthalate. Office Pollution
Prevention and Toxics, Data Gathering and Analysis Division and
Existing Chemicals Risk Assessment Division. April 11, 2022.
2. USEPA. Technical Review of Diisononyl Phthalate [updated]. Office
Pollution Prevention and Toxics, Data Gathering and Analysis
Division and Existing Chemicals Risk Assessment Division. June 2023.
3. Letter to EPA Administrator Carol M. Browner, Re: Petition to Add
Diisononyl Phthalate (DINP) to the Emergency Planning and Community
Right-to-Know Act Section 313 List of Toxic Chemicals. From Laurie
Valeriano, Policy Director, Wastington Toxics Coalition. February
24, 2000.
4. USEPA. Economic Analysis for the Addition of Diisononyl Phthalate
Category; Community Right-to-Know Toxic Chemical Release Reporting.
Prepared by Abt Associates. April 20, 2023.
5. USEPA. Response to Comments Received on the August 8, 2022,
Proposed Rule (87 FR 48128): Addition of Diisononyl Phthalate
Category; Community Right-to-Know Toxic Chemical Release Reporting.
June 2023.
6. Pugh, G.; Isenberg, J.S.; Kamendulis, L.M.; Ackley, D.C.; Clare,
L.J.; Brown, R.; Lington, A.W.; Smith, J.H.; and Klaunig, J.E. 2000.
Effects of di-isononyl phthalate, di-2-ethylhexyl phthalate, and
clofibrate in cynamolgus monkeys. Toxicol. Sci. 56:181-188.
7. Hall, M.; Matthews, A.; Webley, L.; and Harling R. 1999. Effects
of di-isononyl phthalate (DINP) on peroxisomal markers in the
marmoset--DINP is not a peroxisome proliferator. J. Toxicol. Sci.
24: 237-244.
8. Waterman, S.J.; Keller, L.H.; Trimmer, G.W.; Freeman, J.J.;
Nikiforov, A.I.; Harris, S.B., Nicolich, M.J.; and McKee, R.H. 2000.
Two generation reproduction study in rats given di-isononyl
phthalate in the diet. Reprod. Toxicol. 14(1):21-36.
9. Clewell, R. 2011. A Dose Response Study of the Effects on Male
Rat Sexual Development After Administration of Diisononyl Phthalate
to the Pregnant and Lactating Dam. Performing laboratory: The Hamner
Institutes for Health Sciences, Research Triangle Park, NC.
Laboratory Study Number: 10003. Sponsor: ExxonMobil Biochemical
Sciences Inc., location not reported.
10. Masutomi, N.; Shibutani, M.; Takagi, H.; Uneyama, C.; Takahashi,
N.; Hirose, M. 2003. Impact of dietary exposure to methoxychlor,
genistein, or diisononyl phthalate during the perinatal period on
the development of the rat endocrine/reproductive systems in later
life. Toxicology 192:149-170.
11. Hellwig, J.; Freudenberger, H.; and Jackh, R. 1997. Differential
prenatal toxicity of branched phthalate esters in rats. Food and
Chem. Toxicol. 35:501-512.

12. Waterman, S.J.; Ambroso, J.L.; Keller, L.H.; Trimmer, G.W.;
Nikiforov, A.I.; Harris, S.B. 1999. Developmental toxicity of di-
isodecyl and di-isononyl phthalates in rats. Reprod. Toxicol.
13(2):131-136.
13. Australia NICNAS, Priority existing chemical assessment report
no. 35. Diisononyl phthalate. September 2012, Australian Government
Department of Health and Ageing: Sydney, Australia. https://www.industrialchemicals.gov.au/sites/default/files/PEC35-Diisononyl-phthalate-DINP.pdf.
14. Clewell, R.A., et al., 2013. A dose response study to assess
effects after dietary administration of diisononyl phthalate (DINP)
in gestation and lactation on male rat sexual development. Reprod
Toxicol. 35:70-80.
15. Gray, L.E.; Jr, Ostby, J.; Furr, J.; Price, M.; Rao
Veeramachaneni, D.N.; and Parks, L. 2000. Perinatal exposure to the
phthalates DEHP, BBP, and DINP, but not DEP, DMP, or DOTP, alters
sexual differentiation of the male rat. Toxicol. Sci. 58:350-365.
16. Boberg, J., et al., 2011. Reproductive and behavioral effects of
diisononyl phthalate (DINP) in perinatally exposed rats. Reprod
Toxicol. 31(2):200-9.
17. Gray, L.E. 2023. Biologically relevant reductions in fetal
testosterone and Insl3 induced by in utero exposure to high levels
of di-isononyl phthalate (DINP) in male rats. Toxicol. and Appl.
Pharmacol. 465:116454. https://doi.org/10.1016/j.taap.2023.116454.
18. Lington, A.W.; Bird M.G.; Plutnick, R.T.; Stubblefield, W.A.;
and Scala, R.A. 1997. Chronic toxicity and carcinogenic evaluation
of diisononyl phthalate in rats. Fundam. Appl. Toxicol 36: 79-89.
19. Moore, M.R. 1998a. Oncogenicity study in rats with
di(isononyl)phthalate including ancillary hepatocellular
proliferation and biochemical analyses. TSCATS Doc#<PHONE_NUMBER>8. Old
Doc 8EHQ099813083. Fiche # OTS05562832. Submitted by Aristech
Chemical Corporation. Produced by Covance Laboratories 2598-104.
20. Bio/dynamics. (1987). A chronic toxicity carcinogenicity feeding
study in rats with Santicizer 900 with cover letter dated 06/05/87
[TSCA Submission]. (EPA/OTS Doc #86870000362). St. Louis, MO:
Monsanto Company.
21. Moore M.R. 1998b. Oncogenicity study in mice with
di(isononyl)phthalate including ancillary hepatocellular
proliferation and biochemical analyses. TSCATS Doc#<PHONE_NUMBER>6. Old
Doc 8EHQ119813083. Fiche # OTS05562833. Submitted by Aristech
Chemical Corp. Produced by Covance 2598-105.
22. National Institute of Environmental Health Sciences (NIEHS).
2019. Letter to U.S. EPA IRIS Program. https://heronet.epa.gov/heronet/index.cfm/reference/details/reference_id/5098230.
23. Hard GC, Johnson KJ, Cohen SM. 2009. A comparison of rat chronic
progressive nephropathy with human renal disease-implications for
human risk assessment. Crit Rev Toxicol. 39(4):332-346.
24. USEPA. 2021a. Toxicological Review of tert-Butyl Alcohol (tert-
Butanol) [CASRN 75-65-0]. EPA/635/R-20/370Fa. Integrated Risk
Information System, Center for Public Health and the Environmental
Assessment, Office of Research and Development. Washington, DC.
https://iris.epa.gov/static/pdfs/1036tr.pdf.
25. USEPA. 2021b. Toxicological Review of Ethyl Tertiary Butyl Ether
[CASRN 637-92-3]. EPA/635/R-20/400Fa. Integrated Risk Information
System, Center for Public Health and the Environmental Assessment,
Office of Research and Development. Washington, DC. https://iris.epa.gov/static/pdfs/1034tr.pdf.
26. Ma P. et al., 2014. Oral exposure of Kunming mice to diisononyl
phthalate induces hepatic and renal tissue injury through the
accumulation of ROS. Protective effect of melatonin. Food Chem
Toxicol, 68: 247-56.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review

    This action is not a significant regulatory action as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore
not subject to a requirement for Executive Order 12866 review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR
1320.3(b). OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control numbers 2070-0212 and 2050-0078.
    Currently, the facilities subject to the reporting requirements
under EPCRA section 313 and PPA section 6607 may use either EPA Toxic
Chemicals Release Inventory Form R (EPA Form 9350-1), or EPA Toxic
Chemicals Release Inventory Form A (EPA Form 9350-2). The Form R must
be completed if a facility manufactures, processes, or otherwise uses
any listed chemical above threshold quantities and meets certain other
criteria. For the Form A, EPA established an alternative threshold for
facilities with low annual reportable amounts of a listed toxic
chemical. A facility that meets the appropriate reporting thresholds,
but estimates that the total annual reportable amount of the chemical
does not exceed 500 pounds per year, can take advantage of an
alternative manufacture, process, or otherwise use threshold of 1
million pounds per year of the chemical, provided that certain
conditions are met, and submit the Form A instead of the Form R. In
addition, respondents may designate the specific chemical identity of a
substance as a trade secret pursuant to EPCRA section 322, 42 U.S.C.
11042, 40 CFR part 350.
    OMB has approved the reporting and recordkeeping requirements
related to Forms A and R, supplier notification, and petitions under
OMB Control number 2070-0212 (EPA Information Collection Request (ICR)
No. 2613.02) and those related to trade secret designations under OMB
Control 2050-0078 (EPA ICR No. 1428). As provided in 5 CFR 1320.5(b)
and 1320.6(a), 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 OMB control numbers
relevant to EPA's regulations are listed in 40 CFR part 9 and displayed
on the information collection instruments (e.g., forms, instructions).

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities subject to the requirements of
this action are small manufacturing facilities. The Agency has
determined that no small governments or small organizations are
expected to be affected by this action; and that of the 198 to 396
entities estimated to be impacted by this action, 181 to 365 are small
businesses. All small businesses affected by this action are estimated
to incur annualized cost impacts of less than 1%. Thus, this action is
not expected to have a significant adverse economic impact on a
substantial number of small entities. A more detailed analysis of the
impacts on small entities is located in EPA's economic analysis (Ref.
4).

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local or tribal governments and EPA
did not identify any small governments that would be impacted by this
action. EPA's economic analysis indicates that the total industry cost
of this action is estimated to be $968,546 to $1,935,041 in the first
year of

reporting and $461,212 to $921,448 in subsequent years (Ref. 4).

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes. This action relates to toxic chemical
reporting under EPCRA section 313, which primarily affects private
sector facilities. Thus, Executive Order 13175 does not apply to this
action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying to those regulatory actions that concern environmental
health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of Executive Order 13045. This
action is not subject to Executive Order 13045, because it does not
concern an environmental health or safety risk. Since this action does
not concern human health, EPA's Policy on Children's Health also does
not apply.
    Although this action does not concern an environmental health or
safety risk, the data collected as a result of this action will provide
information about releases to the environment that could be used to
inform the public on potential exposures to toxic chemical releases,
pursuant to the right-to-know principles. EPA also believes that the
information obtained as a result of this action could be used by
government agencies, researchers, and others to identify potential
problems, set priorities, and take appropriate steps to reduce any
potential exposures and related human health or environmental risks
identified as a result of increased knowledge of exposures to DINP.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards under the
NTTAA section 12(d), 15 U.S.C. 272.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs
federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or indigenous
peoples) and low-income populations.
    EPA believes that it is not practicable to assess whether the human
health or environmental conditions that exist prior to this action
result in disproportionate and adverse effects on people of color, low-
income populations and/or indigenous peoples. This action adds a
chemical category to the EPCRA section 313 reporting requirements; it
does not directly address any human health or environmental risks and
does not affect the level of protection provided to human health or the
environment. However, EPA believes that the information obtained as a
result of this action could be used by the public (including people of
color, low-income populations and/or Indigenous peoples) to inform
their behavior as it relates to sources of DINP exposure, or by
government agencies and others to identify potential problems, set
priorities, and take appropriate steps to reduce those exposures, as
well as assess any potential human health or environmental risks.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 372

    Environmental protection, Community right-to-know, Reporting and
recordkeeping requirements, and Toxic chemicals.

    Dated: July 6, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

    Therefore, for the reasons set forth in the preamble, EPA is
amending 40 CFR part 372 as follows:

PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW

0
1. The authority citation for part 372 continues to read as follows:

    Authority:  42 U.S.C. 11023 and 11048.

0
2. In Sec.  372.65, adding in alphabetical order an entry to Table 3 in
paragraph (c) for ``Diisononyl Phthalates (DINP)'' to read as follows:

Sec.  372.65  Chemicals and chemical categories to which this part
applies.

* * * * *
    (c) * * *

                        Table 3 to Paragraph (c)
------------------------------------------------------------------------
                     Category name                        Effective date
------------------------------------------------------------------------

                              * * * * * * *
Diisononyl Phthalates (DINP): Includes branched alkyl          1/1/2024
 di-esters of 1,2 benzenedicarboxylic acid in which
 alkyl ester moieties contain a total of nine carbons.
 (This category includes but is not limited to the
 chemicals covered by the CAS numbers and names listed
 here).................................................
    28553-12-0 Diisononyl phthalate....................
    71549-78-5 Branched dinonyl phthalate..............

    14103-61-8 Bis(3,5,5-trimethylhexyl) phthalate.....
    68515-48-0 Di(C8-10, C9 rich) branched alkyl
     phthalates........................................
    20548-62-3 Bis(7-methyloctyl) phthalate............
    111983-10-9 Bis(3-ethylheptan-2-yl) benzene-1,2-
     dicarboxylate.....................................

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2023-14642 Filed 7-13-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42579-42582]
[FR Doc No: 2015-17495]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75441; File No. SR-NYSEMKT-2015-47]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Allowing the Listing of
Options Overlying Portfolio Depositary Receipts and Index Fund Shares
That Are Listed Pursuant to Generic Listing Standards on Equities
Exchanges for Series of ETFs Based on International or Global Indexes
Under Which a Comprehensive Surveillance Sharing Agreement Is Not
Required

July 13, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on July 2, 2015, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to allow the listing of options overlying
portfolio depositary receipts and index fund shares (collectively,
``ETFs'') that are listed pursuant to generic listing standards on
equities exchanges for series of ETFs based on international or global
indexes under which a comprehensive surveillance sharing agreement is
not required. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to amend Commentary .06 to Rule 915
(Criteria for Underlying Securities) to list options overlying ETFs
that are listed pursuant to generic listing standards on equities
exchanges for series of ETFs based on international or global indexes
under which a comprehensive surveillance sharing agreement (``CSSA'' or
``comprehensive surveillance agreement'') is not required.\4\ This
proposal will enable the Exchange to list and trade options on ETFs
without a CSSA provided that the ETF is listed on an equities exchange
pursuant to the

generic listing standards that do not require a CSSA pursuant to Rule
19b-4(e) of the Exchange Act.\5\ Rule 19b-4(e) provides that the
listing and trading of a new derivative securities product by a self-
regulatory organization (``SRO'') shall not be deemed a proposed rule
change, pursuant to paragraph (c)(1) of Rule 19b-4, if the Commission
has approved, pursuant to Section 19(b) of the Act, the SRO's trading
rules, procedures and listing standards for the product class that
would include the new derivatives securities product, and the SRO has a
surveillance program for the product class.\6\ In other words, this
proposal will amend the listing standards to allow the Exchange to list
and trade options on ETFs based on international or global indexes to a
similar degree that they are allowed to be listed on several equities
exchanges.\7\
---------------------------------------------------------------------------

    \4\ See, e.g., NYSE Arca Equities Rule 5.2(j)(3), Commentary
.01(a)(B); NYSE MKT Rule 1000, Commentary .03(a)(B); NASDAQ Rule
5705(a)(3)(A)(ii); and BATS Rule 14.11(b)(3)(A)(ii).
    \5\ 17 CFR 240.19b-4(e).
    \6\ When relying on Rule 19b-4(e), the SRO must submit Form 19b-
4(e) to the Commission within five business days after the SRO
begins trading the new derivative securities products. See
Securities Exchange Act Release No. 40761 (December 8, 1998), 63 FR
70952 (December 22, 1998).
    \7\ See, e.g., NYSE Arca Equities Rule 5.2(j)(3) Commentary
.01(a)(B); NYSE MKT Rule 1000 Commentary .03(a)(B); NASDAQ Rule
5705(a)(3)(A)(ii) and (b)(3)(A)(ii); and BATS Rule
14.11(b)(3)(A)(ii). See also Securities Exchange Act Release Nos.
55621 (April 12, 2007), 72 FR 19571 (April 18, 2007) (SR-NYSEArca-
2006-86); 54739 (November 9, 2006), 71 FR 66993 (SR-Amex-2006-78);
55269 (February 9, 2007), 72 FR 7490 (February 15, 2007) (SR-NASDAQ-
2006-050).
---------------------------------------------------------------------------

Exchange-Traded Funds: Current Commentary .06 to Rule 915
    Currently, the Exchange allows for the listing and trading of
options on ETFs. Commentary .06 to Rule 915 provides the listings
standards for options on ETFs, such as ETFs based on international or
global indexes.\8\ Commentary .06(b)(i) to Rule 915 requires that any
non-U.S. component securities of an index or portfolio of securities on
which the Exchange-Traded Fund Shares are based that are not subject to
a CSSA do not in the aggregate represent more than 50% of the weight of
the index or portfolio. Commentary .06(b)(ii) to Rule 915 requires that
any component securities of an index or portfolio of securities on
which the Exchange-Traded Fund Shares are based for which the primary
market is in any one country that is not subject to a CSSA do not
represent 20% or more of the weight of the index. And, Commentary
.06(b)(iii) to Rule 915 requires that any component securities of an
index or portfolio of securities on which the Exchange-Traded Fund
Shares are based for which the primary market is in any two countries
that are not subject to a CSSA do not represent 33% or more of the
weight of the index.
---------------------------------------------------------------------------

    \8\ See Commentary .06(b)(i)-(v) to Rule 915, to be re-numbered
as proposed Commentary .06(b)(ii)(A)-(E) to Rule 915 as discussed
herein.
---------------------------------------------------------------------------

Generic Listing Standards for Exchange-Traded Funds
    The Exchange notes that the Commission has previously approved
generic listing standards pursuant to Rule 19b-4(e) of the Exchange Act
for ETFs based on indexes that consist of stocks listed on U.S.
exchanges.\9\ In general, the criteria for the underlying component
securities in the international and global indexes are similar to those
for the domestic indexes, but with modifications as appropriate for the
issues and risks associated with non-U.S. securities. In addition, the
Commission has previously approved the listing and trading of ETFs
based on international indexes--those based on non-U.S. component
stocks, as well as global indexes--those based on non-U.S. and U.S.
component stocks.\10\
---------------------------------------------------------------------------

    \9\ See Commentary .03 to Amex Rule 1000 and Commentary .02 to
Amex Rule1000A. See also Securities Exchange Act Release No. 42787
(May 15, 2000), 65 FR 33598 (May 24, 2000).
    \10\ See, e.g., Securities Exchange Act Release Nos. 50189
(August 12, 2004), 69 FR 51723 (August 20, 2004) (approving the
listing and trading of certain Vanguard International Equity Index
Funds); 44700 (August 14, 2001), 66 FR 43927 (August 21, 2001)
(approving the listing and trading of series of the iShares Trust
based on certain S&P global indexes).
---------------------------------------------------------------------------

    In approving ETFs for equities exchange trading, the Commission
thoroughly considered the structure of the ETFs, their usefulness to
investors and to the markets, and SRO rules that govern their trading.
The Exchange believes that allowing the listing of options overlying
ETFs that are listed pursuant to the generic listing standards on
equities exchanges for ETFs based on international and global indexes
and applying Rule 19b-4(e) should fulfill the intended objective of
that rule by allowing options on those ETFs that have satisfied the
generic listing standards to commence trading, without the need for the
public comment period and Commission approval. The proposed rule has
the potential to reduce the time frame for bringing options on ETFs to
market, thereby reducing the burdens on issuers and other market
participants. The failure of a particular ETF to comply with the
generic listing standards under Rule 19b-4(e) would not, however,
preclude the Exchange from submitting a separate filing pursuant to
Section 19(b)(2),\11\ requesting Commission approval to list and trade
options on a particular ETF.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

Requirements for Listing and Trading Options Overlying ETFs Based on
International and Global Indexes
    Options on ETFs listed pursuant to these generic standards for
international and global indexes would be traded, in all other
respects, under the Exchange's existing trading rules and procedures
that apply to options on ETFs and would be covered under the Exchange's
surveillance program for options on ETFs.
    Pursuant to the proposed rule, the Exchange may list and trade
options on an ETF without a CSSA provided that the ETF is listed
pursuant to generic listing standards for series of ETFs based on
international or global indexes under which a comprehensive
surveillance agreement is not required.\12\ The Exchange believes that
these generic listing standards are intended to ensure that stocks with
substantial market capitalization and trading volume account for a
substantial portion of the weight of an index or portfolio.
---------------------------------------------------------------------------

    \12\ See proposed Commentary .06(b)(i) to Rule 915.
---------------------------------------------------------------------------

    The Exchange believes that this proposed listing standard for
options on ETFs is reasonable for international and global indexes,
and, when applied in conjunction with the other listing
requirements,\13\ will result in options overlying ETFs that are
sufficiently broad-based in scope and not readily susceptible to
manipulation. The Exchange also believes that allowing the Exchange to
list options overlying ETFs that are listed on equities exchanges
pursuant to generic standards for series of portfolio depositary
receipts or index fund shares \14\ based on international or global
indexes under which a CSSA is not required, will result in options
overlying ETFs that are adequately diversified in weighting for any
single security or small group of securities to significantly reduce
concerns that trading in options overlying ETFs based on international
or global indexes could become a surrogate for trading in unregistered
securities.
---------------------------------------------------------------------------

    \13\ All of the other listing criteria under the Exchange's
rules will continue to apply to any options listed pursuant to the
proposed rule change.
    \14\ The Exchange notes that the proposed rule text differs
slightly from that of other exchanges, with the exception of BATS
Exchange, in order to make clear that the rule applies to ETFs that
have been listed on equities exchanges pursuant to generic listing
standards for series of ``portfolio depositary receipts or index
fund shares'' rather than ``portfolio depositary receipts and index
fund shares.'' Such difference does not represent a substantive
difference from the rules of other exchanges. See infra n. 18.
---------------------------------------------------------------------------

    The Exchange believes that ETFs based on international and global

indexes that have been listed pursuant to the generic standards are
sufficiently broad-based enough so as to make options overlying such
ETFs not susceptible instruments for manipulation. The Exchange
believes that the threat of manipulation is sufficiently mitigated for
underlying ETFs that have been listed on equities exchanges pursuant to
generic listing standards for series of portfolio depositary receipts
or index fund shares based on international or global indexes under
which a comprehensive surveillance agreement is not required and for
the overlying options, that the Exchange does not see the need for a
CSSA to be in place before listing and trading options on such ETFs.
The Exchange notes that its proposal does not replace the need for a
CSSA as provided in the current rule. The provisions of the current
rule, including the need for a CSSA, remain materially unchanged in the
proposed rule and will continue to apply to options on ETFs that are
not listed on an equities exchange pursuant to generic listing
standards for series of portfolio depositary receipts or index fund
shares based on international or global indexes under which a
comprehensive surveillance agreement is not required. Instead, the
proposed rule adds an additional listing mechanism for certain
qualifying options on ETFs to be listed on the Exchange.
    Finally, the Exchange is also proposing to make several non-
substantive changes to the rule text in order to make it easier to read
and understand. Specifically, to account for proposed Commentary
.06(b)(i) to Rule 915, the Exchange proposes to re-number current
Commentary .06(b)(i)-(v) as proposed Commentary .06(b)(ii)(A)-(E), and
to make clear that each of the proposed newly numbered paragraphs apply
to the series of Exchange-Traded Fund Shares that do not meet the
criteria in proposed Commentary .06(b)(i) to Rule 915.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \15\ of
the Securities Exchange Act of 1934 (the ``Act''), in general, and
furthers the objectives of Section 6(b)(5),\16\ in particular, in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In particular, the proposed rule change has the potential to reduce
the time frame for bringing options on ETFs to market, thereby reducing
the burdens on issuers and other market participants. The Exchange also
believes that enabling the listing and trading of options on ETFs
pursuant to this new listing standard will benefit investors by
providing them with valuable risk management tools. The Exchange notes
that its proposal does not replace the need for a comprehensive
surveillance agreement as provided in the current rule. The provisions
of the current rule, including the need for a CSSA, remain materially
unchanged and will continue to apply to options on ETFs that are not
listed on an equities exchange pursuant to generic listing standards
for series of portfolio depositary receipts or index fund shares based
on international or global indexes under which a comprehensive
surveillance agreement is not required. Instead, proposed Commentary
.06(b)(i) to Rule 915 adds an additional listing mechanism for certain
qualifying options on ETFs to be listed on the Exchange in a manner
that is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
    The Exchange also believes that the proposed non-substantive
organizational changes are reasonable, fair, and equitable because they
are designed to make the rule easier to comprehend. As noted above, the
proposed non-substantive changes do not change the need for a CSSA as
provided in the current rule. The provisions of the current rule,
including the need for a CSSA, remain materially unchanged in the
proposed rule and will continue to apply to options on ETFs that are
not listed on an equities exchange pursuant to generic listing
standards for series of portfolio depositary receipts or index fund
shares based on international or global indexes under which a
comprehensive surveillance agreement is not required. These non-
substantive changes to the rules are intended to make the rules clearer
and less confusing for participants and investors and to eliminate
potential confusion, thereby removing impediments to and perfecting the
mechanism of a free and open market and a national market system, and,
in general, protecting investors and the public interest.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\17\ the Exchange
does not believe that the proposed rule change would impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act. To the contrary, the proposed rule change is a
competitive change that is substantially similar to recent rule changes
filed by MIAX Options Exchange (``MIAX''), NASDAQ OMX PHLX LLC
(``Phlx''), International Securities Exchange LLC (``ISE''), BOX
Options Exchange LLC (``BOX'') and BATS Exchange (``BATS'').\18\
Furthermore, the Exchange believes this proposed rule change will
benefit investors by providing additional methods to trade options on
ETFs, and by providing them with valuable risk management tools.
Specifically, the Exchange believes that market participants on the
Exchange would benefit from the introduction and availability of
options on ETFs in a manner that is similar to equities exchanges and
will provide investors with a venue on which to trade options on these
products. For all the reasons stated above, the Exchange does not
believe that the proposed rule changes will impose any burden on
competition not necessary or appropriate in furtherance of the purposes
of the Act, and believes the proposed change will enhance competition
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b)(8).
    \18\ See Securities Exchange Act Release Nos. 74509 (March 13,
2015), 80 FR 14425 (March 19, 2015) (SR-MIAX-2015-04); 74553 (March
20, 2015) 80 FR 16072 (March 26, 2015) (SR-Phlx-2015-27); 74832
(April 29, 2015), 80 FR 25738 (May 5, 2015) (SR-ISE-2015-16); 75132
(June 9, 2015), 80 FR 34175 (June 15, 2015) (SR-BOX-2015-21), 75166,
(June 12, 2015), 80 FR 34946 (June 18, 2015) (SR-BATS-2015-43).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public

interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \19\ and Rule 19b-
4(f)(6) thereunder.\20\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \21\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \22\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The Exchange
stated that waiver of the operative delay will permit the Exchange to
list and trade certain ETF options on the same basis as other options
markets.\23\ The Commission believes the waiver of the operative delay
is consistent with the protection of investors and the public interest.
Therefore, the Commission hereby waives the operative delay and
designates the proposal operative upon filing.\24\
---------------------------------------------------------------------------

    \21\ 17 CFR 240.19b-4(f)(6).
    \22\ 17 CFR 240.19b-4(f)(6)(iii).
    \23\ See supra note 18.
    \24\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2015-47 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2015-47. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2015-47, and should
be submitted on or before August 7, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-17495 Filed 7-16-15; 8:45 am]
 BILLING CODE 8011-01-P


CRC Report No. E-77-2b

Determine Evaporative Emissions Breakdown Including Permeation Effects
and Diurnal Emissions on Aging Enhanced Evaporative Emissions Certified
Vehicles (CRC E-77-2b)

This report is currently not available

Due for release mid-2010

For information please contact:

Connie Hart (WAM)

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
(734) 214-4340

*NOT AVAILABLE*