[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17146-17151]
[FR Doc No: 2017-07131]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0005; FRL-9959-90]

Acetamiprid; Pesticide Tolerances for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of acetamiprid in or on sugarcane, cane and sugarcane,
molasses. This action is associated with the issuance of a crisis
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) authorizing use of the pesticide on sugarcane. This regulation
establishes maximum permissible levels for residues of acetamiprid in
or on sugarcane, cane and sugarcane, molasses. The time-limited
tolerances expire on December 31, 2019.

DATES: This regulation is effective April 10, 2017. Objections and
requests for hearings must be received on or before June 9, 2017, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0005, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2017-0005 in the subject line on the first page of your submission. All
objections and requests for a hearing must be in writing, and must be
received by the Hearing Clerk on or before June 9, 2017. Addresses for
mail and hand delivery of objections and hearing requests are provided
in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-

2017-0005, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(l)(6), is
establishing time-limited tolerances for residues of acetamiprid, (1E)-
N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, in or
on sugarcane, cane at 45 parts per million (ppm) and sugarcane,
molasses at 600 ppm. These time-limited tolerances expire on December
31, 2019.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption issued under FIFRA section 18.
Such tolerances can be established without providing notice or period
for public comment. EPA does not intend for its actions on FIFRA
section 18 related time-limited tolerances to set binding precedents
for the application of FFDCA section 408 and the safety standard to
other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Acetamiprid on Sugarcane and FFDCA
Tolerances

    With EPA's concurrence, the Louisiana Department of Agriculture and
Forestry (LDAF) declared a crisis on June 17, 2016 necessitating the
use of acetamiprid to control the West Indian canefly on sugarcane. At
that time, LDAF stated that substantial yield losses had likely already
occurred in sugarcane, and the West Indian canefly populations were
moving into other crops nearby, posing significant risk to these crops
as well.
    The state agency asserted that an emergency condition exists in
accordance with the criteria for approval of an emergency exemption,
and issued a crisis exemption under FIFRA section 18 to allow the use
of acetamiprid on sugarcane for control of West Indian canefly in
Louisiana. After having reviewed the submission, EPA concurred that an
emergency condition exists.
    As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of acetamiprid
in or on sugarcane cane and sugarcane molasses. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerance under FFDCA section 408(l)(6)
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in FFDCA
section 408(l)(6). Although these time-limited tolerances expire on
December 31, 2019, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerances
remaining in or on sugarcane cane and sugarcane molasses after that
date will not be unlawful, provided the pesticide was applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these time-limited tolerances at the time
of that application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
    Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
acetamiprid meets FIFRA' s registration requirements for use on
sugarcane, or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance decision serves as a basis for registration of
acetamiprid by a State for special local needs under FIFRA section
24(c). Nor do these tolerances by themselves serve as the authority for
persons in any State other than Louisiana to use this pesticide on the
applicable crops under FIFRA section 18 absent the issuance of an
emergency exemption applicable within that State. For additional
information regarding the emergency exemption for acetamiprid, contact
the Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerances for residues of acetamiprid on sugarcane,
cane at 45 ppm and sugarcane, molasses at 600 ppm. EPA's assessment of
exposures and risks associated with establishing time-limited
tolerances follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in

evaluating the risk posed by human exposure to the pesticide. For
hazards that have a threshold below which there is no appreciable risk,
the toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which no adverse effects are observed (the NOAEL) and the lowest
dose at which adverse effects of concern are identified (the LOAEL).
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    The complete human health risk assessment for this action may be
found at http://www.regulations.gov in the document ``Acetamiprid.
Aggregate Human Health Risk Assessment for the Proposed FIFRA Section
18 Specific Exemption Use of the Insecticide on Sugarcane in
Louisiana'' in the docket for ID number EPA-HQ-OPP-2017-0005.
Additionally, a summary of the toxicological endpoints for acetamiprid
used for human risk assessment is discussed in Unit III. of the final
rule published in the Federal Register of November 6, 2015 (80 FR
68772) (FRL-9936-12).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetamiprid, EPA considered exposure under the time-limited
tolerances established by this action as well as all existing
acetamiprid tolerances in 40 CFR 180.578. EPA assessed dietary
exposures from acetamiprid in food as follows:
    i. Acute exposure. Acute effects were identified for acetamiprid.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
2003-2008 National Health and Nutrition Examination Survey; What We Eat
in America (NHANES/WWEIA). As to residue levels in food, EPA assumed
one hundred percent crop treated (PCT), and established and proposed
tolerance level residues except as follows for sugarcane molasses. No
residue data were available for sugarcane molasses, and residue data
from sweet corn stover were used as a surrogate. The Agency determined
it appropriate to translate corn stover data to sugarcane, and the use
patterns and maximum application rates for sweet corn and sugarcane are
similar. The residue level of 240 ppm acetamiprid in sugarcane molasses
and sugarcane molasses baby food was used for dietary risk assessment,
which is less than the recommended tolerance of 600 parts per million
(ppm). The 240 ppm level is based on the highest average field trial
acetamiprid residue level of 20 ppm in sweet corn stover, multiplied by
the average molasses processing factor of 12X. The average processing
factor was derived from molasses processing data for 9 other
pesticides, and results in a residue estimate that is more
representative of potential levels which could occur in these
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA again used the food consumption data from the USDA's
2003-2008 NHANES/WWEIA. Residue levels in food were included as
explained in Unit IV.B.1.i. of this document at tolerance-level
residues for established and proposed tolerances and 240 ppm for
sugarcane molasses and sugarcane molasses baby food. Additionally, 100
PCT was assumed.
    iii. Cancer. Based on the data referenced in Unit IV.A., EPA has
concluded that acetamiprid does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for acetamiprid. As detailed in the previous
section, residues were estimated for sugarcane molasses and sugarcane
molasses baby food based upon data for sweet corn and incorporating an
appropriate processing factor derived from processing data for 9 other
pesticides in sugarcane. Tolerance level residues were used for the
remainder of the commodities and 100 PCT were assumed for all food
commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for acetamiprid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of acetamiprid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    EPA used the Food Quality Protection Act Index Reservoir Screening
Tool and the Provisional Cranberry Model to generate to generate
surface water Estimated Drinking Water Concentrations (EDWCs) for use
in the human health dietary risk assessment, while the Pesticide Root
Zone Model for Groundwater was used to generate groundwater EDWCs. The
EDWCs of acetamiprid for acute exposures were estimated at 88.3 parts
per billion (ppb) for surface water and 49.7 ppb for ground water. For
chronic exposures (non-cancer assessment) the EDWCs were estimated at
32.2 ppb for surface water and 45.0 ppb for ground water. To assess
dietary exposure contribution from drinking water, the higher acute
EDWC of 88.3 ppb was used for acute assessment and for chronic
exposures, the higher EDWC of 45 ppb was used. These modeled EDWCs were
directly entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Residential exposures to acetamiprid could result from the
currently registered uses of spot-on dog treatments, application to
mattresses, and as crack and crevice treatments. For the dog spot-on
products, EPA determined that short- and intermediate-term residential
exposures may occur for residential (non-professional) applicators
through dermal and inhalation routes; and short- intermediate- and
long-term exposures may occur post-application for adults and children
through dermal exposures, and also through incidental oral ingestion
for children 1-2 years old. For the mattress, crack, and crevice
treatments, short- and intermediate-term residential handler exposure
may occur through dermal and inhalation routes; and short- and
intermediate-term exposures may occur post application for adults and
children through dermal and inhalation routes, and also through
incidental oral ingestion for children 1-2 years old. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at: https://www.epa.gov/pesticide-
science-and-assessing-pesticide-risks/standard-

operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found acetamiprid to share a common mechanism of
toxicity with any other substances, and acetamiprid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
acetamiprid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The pre- and post-natal
toxicity databases for acetamiprid include developmental toxicity
studies in the rat and rabbit, developmental neurotoxicity (DNT) study
in rats and a 2-generation reproduction toxicity study in rats. There
was no evidence of increased quantitative or qualitative susceptibility
of rat or rabbit fetuses following in utero exposure to acetamiprid in
the developmental toxicity studies. In the DNT and 2-generation
reproduction studies there was no evidence of quantitative increased
susceptibility observed However, there was evidence of increased
qualitative susceptibility of rat pups seen in the studies. In the DNT
study in rats, although both maternal and offspring effects were seen
at the same dose level, offspring animals were more severely affected.
Decreased pre-weaning survival, and decreased maximum auditory startle
response were observed in the presence of limited maternal toxicity
(body weight effects). In the 2-generation reproduction study, effects
observed were a decrease in mean body weight, body weight gain, and
food consumption in the parental animals, and significant reductions in
body weights in pups (both generations). Also, reduction in litter size
and viability and weaning indices were seen among the second generation
of offspring, as well as significant delays in the age to attain
vaginal opening and preputial separation. These offspring adverse
effects were more severe than the parental effects.
    3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for acetamiprid is complete.
    ii. Although there was evidence of increased qualitative
susceptibility of the young in the DNT and 2-generation reproduction
studies in rats, there are clear NOAELs identified for the effects
observed in the toxicity studies. Also, there was no evidence of
increased quantitative or qualitative susceptibility of rat or rabbit
fetuses in the developmental toxicity studies.
    iii. Acetamiprid produced signs of neurotoxicity in the high dose
groups in the acute and developmental neurotoxicity studies in rats and
the subchronic toxicity study in mice. However, no neurotoxic findings
were reported in the subchronic neurotoxicity study in rats.
Additionally, there are clear NOAELs identified for the effects
observed in the toxicity studies. The doses and endpoints selected for
risk assessment are protective and account for all toxicological
effects observed in the database, including neurotoxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in exposure
assessments (food, drinking water and residential) assessment,
including the use of 100 PCT assumptions, tolerance-level residue
values, and upper-bound estimates of potential exposure through
drinking water. In addition, the residential exposure assessment was
conducted such that residential exposure and risk will not be
underestimated. The aggregate exposure and risk estimates considered
are expected to over-estimate the actual exposure and risk anticipated,
based on the current and proposed use patterns; no risk estimates of
concern were identified. These assessments will not underestimate the
exposure and risks posed by acetamiprid.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to acetamiprid will occupy 69% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure. Typically,
EPA does not consider residential exposures when assessing acute
aggregate risk unless such exposures can be characterized as a series
of single-day exposures. For acetamiprid, residential exposures are
assessed as short- and intermediate-term exposures. Therefore, acute
aggregate risk estimates for acetamiprid are equivalent to the acute
dietary risk estimates which are not of concern.
    2. Chronic risk. Using the exposure assumptions described in unit
IV. for chronic exposure, EPA has concluded that chronic exposure to
acetamiprid from food and water will utilize 62% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Dietary exposure from food and water, considered to be a
background exposure level, is included in aggregate exposures for all
population groups. Based on the explanation in Unit IV.B.3., adult
aggregate chronic exposures also include long-term post-application
dermal exposure from contact with dogs following spot-on treatment. For
children 1 to 2 years old, aggregate chronic exposures also include
long-term post-application dermal and incidental oral exposures from
contact with spot-on treated dogs. The chronic dietary exposure and
post-application pet spot-on residential exposure were aggregated and
compared to the long-term POD. Adult and children long-term aggregate
MOEs were 390 and 100,

respectively, and are above the level of concern of an MOE <100,
indicating that risk estimates are not of concern. The chronic dietary
exposure estimates are highly conservative, assuming tolerance-level
residues for registered uses and 100 PCT for all commodities.
Therefore, EPA also considers the aggregate MOEs to be conservative
estimates.
    3. Short- and Intermediate-term risk. Acetamiprid is currently
registered for uses that could result in short/intermediate-term
residential exposure. Short- (1 to 30 days) and intermediate-term (1-6
months) aggregate exposures take into account short- and intermediate-
term residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Toxicological endpoints
and points of departure for assessing short- and intermediate-term
risks (including oral, dermal, and inhalation routes of exposure) are
identical for acetamiprid. Therefore, separate assessments were not
conducted and one risk assessment addresses both of these durations.
Using the exposure assumptions described in unit IV.B.3. for short/
intermediate-term exposures, EPA has concluded the combined short/
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 290 for adults and 110 for children. Because EPA's
level of concern for acetamiprid is an MOE of <100, these MOEs do not
indicate risks of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, acetamiprid is classified as ``not likely to be carcinogenic
to humans'' and is therefore not expected to pose a cancer risk to
humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to acetamiprid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the
tolerance expression, including gas chromatography with electron
capture detection (GC/ECD) for vegetables and non-citrus fruits, high
performance liquid chromatography with ultraviolet detection (HPLC/UV)
for citrus fruits only, and HPLC with tandem mass spectrometric
detection (LC/MS/MS) for vegetables and non-citrus fruits.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex is a joint United Nations Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established an MRL for acetamiprid on sugarcane.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of
acetamiprid, (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-
methylethanimidamide, in or on sugarcane, cane at 45 ppm and sugarcane,
molasses at 600 ppm. These tolerances expire on December 31, 2019.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA submitted a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping requirements.

    Dated: March 16, 2017.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.578, revise paragraph (b) to read as follows:

Sec.  [emsp14]180.578   Acetamiprid; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
acetamiprid, (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-
methylethanimidamide, in or on the specified agricultural commodities,
resulting from use of the pesticide pursuant to FIFRA section 18
emergency exemptions. Compliance with the tolerance levels specified
below is to be determined by measuring only acetamiprid. The tolerances
expire on the date specified in the table.

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date
------------------------------------------------------------------------
Sugarcane, cane...............................           45   12/31/2019
Sugarcane, molasses...........................          600   12/31/2019
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-07131 Filed 4-7-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Page 36349]
[FR Doc No: 2014-15013]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9603; 34-72448; File No. 265-28]

Investor Advisory Committee Meeting

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee.

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

SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting. The public is invited to submit
written statements to the Committee.

DATES: The meeting will be held on Thursday, July 10, 2014 from 10:00
a.m. until 4:00 p.m. (EDT). Written statements should be received on or
before July 10, 2014.

ADDRESSES: The meeting will be held in Multi-Purpose Room LL-006 at the
Commission's headquarters, 100 F Street NE., Washington, DC 20549. The
meeting will be webcast on the Commission's Web site at www.sec.gov.
Written statements may be submitted by any of the following methods:

Electronic Statements

    [ssquf] Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to<EMAIL_ADDRESS>Please
include File No. 265-28 on the subject line; or

Paper Statements

    [ssquf] Send paper statements to Kevin M. O'Neill, Deputy
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1580,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: Marc Sharma, Senior Special Counsel,
Office of the Investor Advocate, at<PHONE_NUMBER>, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public,
except during portions of the meeting reserved for meetings of the
Committee's subcommittees. Persons needing special accommodations to
take part because of a disability should notify the contact person
listed in FOR FURTHER INFORMATION CONTACT.
    The agenda for the meeting includes: Remarks from Commissioners; a
public administrative session; a discussion of the definition of
accredited investor (which may include a recommendation of the Investor
as Purchaser subcommittee); a discussion of elder fraud; a briefing by
Commission staff on market structure and the proposed Market Structure
Advisory Committee; and nonpublic subcommittee meetings.

    Dated: June 23, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-15013 Filed 6-25-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Proposed Rules]
[Pages 27061-27069]
[FR Doc No: 2019-12115]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0263; FRL-9994-85]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (19-2.B)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 8 chemical substances which are
the subject of premanufacture notices (PMNs). This action would require
persons to notify EPA at least 90 days before commencing manufacture
(defined by statute to include import) or processing of any of these 8
chemical substances for an activity that is designated as a significant
new use by this proposed rule. If this proposed rule is made final,
persons may not commence manufacture or processing for the significant
new use until they have submitted a Significant New Use Notice, and EPA
has conducted a review of the notice, made an appropriate determination
on the notice, and has taken any actions as are required as a result of
that determination.

DATES: Comments must be received on or before July 11, 2019.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0263, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. 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. Potentially affected entities may include:
     Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these proposed SNURs
would need to certify their compliance with the SNUR requirements
should these proposed rules be finalized. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20, any persons who export or intend
to export a chemical substance that is the subject of this proposed
rule on or after July 11, 2019 are subject to the export notification
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
or email. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 8
chemical substances which were the subjects of PMNs P-16-425, P-18-125,
P-18-228, P-18-234, P-18-270, P-18-322, P-19-4, and P-19-34. These
proposed SNURs would require persons who intend to manufacture or
process any of these chemical substances for an activity that is
designated as a significant new use to notify EPA at least 90 days
before commencing that activity.
    The record for the proposed SNURs on these chemicals was
established as docket EPA-HQ-OPPT-2019-0263. That record includes
information considered by the Agency in developing these proposed
SNURs.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)(i)
(15 U.S.C. 2604(a)(1)(B)(i)) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
or process the chemical substance for that use. TSCA prohibits such
manufacturing or processing from commencing until EPA has conducted a
review of the SNUN, made an appropriate determination on the SNUN, and
taken such actions as are required in association with that
determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V.,
the general SNUR provisions are found at 40 CFR part 721, subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees

appear at 40 CFR part 700. Pursuant to Sec.  721.1(c), persons subject
to these SNURs must comply with the same SNUN requirements and EPA
regulatory procedures as submitters of PMNs under TSCA section
5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and 5(d)(1) (15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions
authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and
the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must
either determine that the significant new use is not likely to present
an unreasonable risk of injury or take such regulatory action as is
associated with an alternative determination before the manufacture or
processing for the significant new use can commence. If EPA determines
that the significant new use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute significant new uses for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the conditions of use of the substances, in the context
of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements
for 8 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substances if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR.
    This information may include testing not required to be conducted
but which would help characterize the potential health and/or
environmental effects of the PMN substance. Any recommendation for
information identified by EPA was made based on EPA's consideration of
available screening-level data, if any, as well as other available
information on appropriate testing for the chemical substance. Further,
any such testing identified by EPA that includes testing on vertebrates
was made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models. EPA also recognizes that
whether testing/further information is needed will depend on the
specific exposure and use scenario in the SNUN. EPA encourages all SNUN
submitters to contact EPA to discuss any potential future testing. See
Unit VII. for more information.
     CFR citation assigned in the regulatory text section of
these proposed rules.
    The regulatory text section of these proposed rules specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
    The chemical substances that are the subject of these proposed
SNURs are undergoing premanufacture review. EPA has initially
determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that
certain changes from the intended conditions of use described in the
PMNs could result in changes in the type or form of exposure to the
chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances. Consequently, EPA is proposing to
designate these changes as significant new uses.

PMN Number: P-16-425

    Chemical name: Amino-silane (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical reactant used
in manufacturing a polymer. Based on the physical/chemical properties
of the PMN substance and Structure Activity Relationships (SAR)
analysis of test data on analogous substances. EPA has identified
concerns for irritation, lung effects, developmental effects,
neurotoxicity, liver effects and skin sensitization if the chemical
substance is not used following the limitations noted. The conditions
of use of the PMN substance as described in the PMN include the
following protective measure:
    1. Use other than as a chemical intermediate.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of specific target
organ toxicity or pulmonary effects, reproductive/developmental
toxicity, neurotoxicity and skin sensitization testing would help
characterize the potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11258.

PMN Number: P-18-125

    Chemical name: Oxoalkylcarboxylic acid, sodium salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a reagent in coating
material. Based on the physical/chemical properties of the PMN
substance and Structure Activity Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for kidney
toxicity, eye, skin and lung irritation and developmental toxicity if
the chemical

substance is not used following the limitations noted. The conditions
of use of the PMN substance as described in the PMN include the
following protective measures:
    1. No manufacture of the PMN substance in the United States (i.e.,
import only); and
    2. No use other than the confidential use described in the PMN.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of irritation and
sensitization testing would help characterize the potential health
effects of the PMN substance.
    CFR citation: 40 CFR 721.11260.

PMN Number: P-18-228

    Chemical name: Branched alkenyl acid, alkyl ester, homopolymer
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a tackifier. Based on the
physical/chemical properties of the PMN substance and Structure
Activity Relationships (SAR) analysis of test data on analogous
substances, EPA has identified concerns for eye irritation,
neurotoxicity, systemic, blood, respiratory and cardiovascular effects
and developmental toxicity if the chemical substance is not used
following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measures:
    1. No use other than the confidential use identified in the PMN;
and
    2. No manufacture, processing or use of the PMN substance in any
manner that results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of specific target
organ toxicity, pulmonary effects, developmental toxicity, and
neurotoxicity testing would help characterize the potential health
effects of the PMN substance.
    CFR citation: 40 CFR 721.11261.

PMN Number: P-18-234

    Chemical name: Alkenoic acid, reaction products with bis
substituted alkane and ether polyol (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating component.
Based on the physical/chemical properties of the PMN substance and
Structure Activity Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for skin and eye
irritation and sensitization if the chemical substance is not used
following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measure:
    1. No use of the PMN substance involving spray application that
results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of skin irritation,
eye damage and skin sensitization testing would help characterize the
potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11262.

PMN Number: P-18-270

    Chemical name: Ethanol, 2-butoxy-, 1,1'-ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the uses of the substance
will be as an active co-solvent for solvent-based coatings; a
coalescent for industrial water-based coatings; a coupling agent and
solvent in industrial cleaners, rust removers, hard surface cleaners
and disinfectants; and a primary solvent in solvent-based silk screen
printing inks. Based on the physical/chemical properties of the PMN
substance and Structure Activity Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for skin
irritation, solvent neurotoxicity, immunotoxicity, and developmental,
reproductive, liver and blood toxicity, if the chemical substance is
not used following the limitations noted. The conditions of use of the
PMN substance as described in the PMN include the following protective
measures:
    1. No use of the PMN substance for other than the uses described in
the PMN; and
    2. No use of the PMN substance in a consumer product.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of toxicokinetics,
specific target organ toxicity, skin irritation, and reproductive
toxicity testing would help characterize the potential health effects
of the PMN substance.
    CFR citation: 40 CFR 721.11263.

PMN Number: P-18-322

    Chemical name: Heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)-
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a fragrance ingredient in
consumer products. Based on the physical/chemical properties of the PMN
substance and test data on the PMN substance, EPA has identified
concerns for skin irritation and sensitization and gastrointestinal
tract effects, liver and thyroid toxicity and blood effects if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
    1. No manufacture of the PMN substance in the United States (i.e.,
import only); and
    2. No processing (formulation) to a concentration of greater than
5% of the PMN substance by weight.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed

SNUR. EPA has determined that the results of specific target organ
toxicity testing would help characterize the potential health effects
of the PMN substance.
    CFR citation: 40 CFR 721.11264.

PMN Number: P-19-4

    Chemical name: Aromatic dianhydride, polymer with aromatic diamine
and heteroatom bridged aromatic diamine, reaction products with
aromatic anhydride (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as molded parts and
components. Based on the physical/chemical properties of the PMN
substance and Structure Activity Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for lung
overload if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
    1. No manufacture, processing or use of the PMN substance in any
manner that results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of pulmonary effects
testing would help characterize the potential health effects of the PMN
substance.
    CFR citation: 40 CFR 721.11265.

PMN Number: P-19-34

    Chemical name: Metal, bis(2,4-pentanedionato-kO2,kO4)- (T-4)-
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a contained use as a
component of tires. Based on the physical/chemical properties of the
PMN substance and Structure Activity Relationships (SAR) analysis of
test data on analogous substances, EPA has identified concerns for eye
irritation, blood, liver, kidney, GI and reproductive/developmental
effects, neurotoxicity, immunotoxicity, and genetic toxicity if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
    1. No manufacture of the PMN substance in the United States (i.e.,
import only); and
    2. No use other than the confidential use described in the PMN
including the engineering controls for processing and use as described
in the PMN.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of specific target
organ toxicity, reproductive/developmental toxicity, and neurotoxicity
testing would help characterize the potential health effects of the PMN
substance.
    CFR citation: 40 CFR 721.11266.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are the subject of these proposed SNURs and as further discussed
in Unit IV, EPA identified certain reasonably foreseen changes from the
conditions of use identified in the PMNs and determined that those
changes could result in changes in the type or form of exposure to the
chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances.

B. Objectives

    EPA is proposing SNURs for 8 specific chemical substances which are
undergoing premanufacture review because the Agency wants to achieve
the following objectives with regard to the significant new uses that
would be designated in this proposed rule:
     EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     EPA would be obligated to make a determination under TSCA
section 5(a)(3) regarding the use described in the SNUN, under the
conditions of use. The Agency will either determine under section
5(a)(3)(C) that the significant new use is not likely to present an
unreasonable risk, including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified as relevant by the
Administrator under the conditions of use, or make a determination
under section 5(a)(3)(A) or (B) and take the required regulatory action
associated with the determination, before manufacture or processing for
the significant new use of the chemical substance can occur.
    Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Inventory.
Guidance on how to determine if a chemical substance is on the TSCA
Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Applicability of the Proposed Rules to Uses Occurring Before the
Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
were undergoing premanufacture review at the time of signature of this
proposed rule and were not on the TSCA Inventory. In cases where EPA
has not received a notice of commencement (NOC) and the chemical
substance has not been added to the TSCA Inventory, no person may
commence such activities without first submitting a PMN. Therefore, for
the chemical substances subject to these proposed SNURs, EPA concludes
that the proposed significant new uses are not ongoing.
    EPA designates June 6, 2019 as the cutoff date for determining
whether the new use is ongoing. The objective of EPA's approach is to
ensure that a person cannot defeat a SNUR by initiating a significant
new use before the effective date of the final rule.
    Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified on or after
that date would have to cease any such activity upon the effective date
of the final rule. To resume their activities, these persons would have
to first comply with all applicable SNUR notification requirements and
EPA would have to take action under section 5 allowing manufacture or
processing to proceed.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known to or reasonably ascertainable by them (see 40
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Unit IV. lists potentially
useful information for all SNURs listed here. Descriptions are provided
for informational purposes. The potentially useful information
identified in Unit IV. will be useful to EPA's evaluation in the event
that someone submits a SNUN for the significant new use. Companies who
are considering submitting a SNUN are encouraged, but not required, to
develop the information on the substance, which may assist with EPA's
analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA section 5(e) or 5(f). EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0263.

X. Statutory and Executive Order Reviews

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

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    This proposed rule would establish SNURs for 8 new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Support Division, Office of Mission Support (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001. Please remember to include the OMB control number in any
correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this proposed SNUR would
not have a significant adverse economic impact on a substantial number
of small entities. The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of

SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in
FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018,
only a fraction of these were from small businesses. In addition, the
Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this proposed SNUR are not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its
general determination that final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this proposed
rule. As such, EPA has determined that this proposed rule does not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect on small governments subject to the requirements of
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1531-1538 et seq.).

E. Executive Order 13132: Federalism

    This action would not have a substantial direct effect on 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, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).

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

    This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor does it involve or impose
any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175 (65 FR 67249, November 9, 2000),
do not apply to this proposed rule.

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

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.

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

    This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical
standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to
this action.

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

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: May 31, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 721 be amended as
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec. Sec.  721.11258 and 721.11260 through 721.11266 to subpart
E to read as follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
721.11258 Amino-silane (generic).
721.11260 Oxoalkylcarboxylic acid, sodium salt (generic).
721.11261 Branched alkenyl acid, alkyl ester, homopolymer (generic).
721.11262 Alkenoic acid, reaction products with bis substituted
alkane and ether polyol (generic).
721.11263 Ethanol, 2-butoxy-, 1,1'-ester (generic).
721.11264 Heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)-
(generic).
721.11265 Aromatic dianhydride, polymer with aromatic diamine and
heteroatom bridged aromatic diamine, reaction products with aromatic
anhydride (generic).
721.11266 Metal, bis(2,4-pentanedionato-kO2,kO4)- (T-4)- (generic).

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.  721.11258   Amino-silane (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amino-
silane (PMN P-16-425) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i), are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11260   Oxoalkylcarboxylic acid, sodium salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
oxoalkylcarboxylic acid, sodium salt (P-18-125) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in

Sec.  721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11261   Branched alkenyl acid, alkyl ester, homopolymer
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
branched alkenyl acid, alkyl ester, homopolymer (P-18-228) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j). It is a significant new use to
manufacture, process or use the substance in any manner that results in
inhalation exposures.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11262   Alkenoic acid, reaction products with bis substituted
alkane and ether polyol (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkenoic acid, reaction products with bis substituted alkane and ether
polyol (P-18-234) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to use the substance involving spray application
that results in inhalation exposures.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), (j) and (k) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11263   Ethanol, 2-butoxy-, 1,1'-ester (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
ethanol, 2-butoxy-, 1,1'-ester (P-18-270) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80(o). It is a significant new use to use the
substance for other than an active co-solvent for solvent-based
coatings; a coalescent for industrial water-based coatings; a coupling
agent and solvent for industrial cleaners, rust removers, hard surface
cleaners and disinfectants; and a primary solvent in solvent-based silk
screen printing inks.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11264   Heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)-
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)- (P-18-322) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to process
(formulate) the substance to a concentration of greater than 5% by
weight.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11265   Aromatic dianhydride, polymer with aromatic diamine
and heteroatom bridged aromatic diamine, reaction products with
aromatic anhydride (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
aromatic dianhydride, polymer with aromatic diamine and heteroatom
bridged aromatic diamine, reaction products with aromatic anhydride (P-
19-4) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process or use of the substance in
any manner that results in inhalation exposures.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11266   Metal, bis(2,4-pentanedionato-kO2,kO4)- (T-4)-
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as metal,
bis(2,4-pentanedionato-kO2,kO4)- (T-4)- (P-19-34) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (j). It is a significant new use to
process or use the substance without the engineering controls described
in the premanufacture notice.

    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

[FR Doc. 2019-12115 Filed 6-10-19; 8:45 am]
 BILLING CODE 6560-50-P