[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73218-73224]
[FR Doc No: 2014-28955]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0695; FRL-9919-34]

Diisopropanolamine; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of diisopropanolamine when used as an inert
ingredient (neutralizer or stabilizer) at no more than 10% in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest. United Phosphorus, Inc. submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting establishment of an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of diisopropanolamine.

DATES: This regulation is effective December 10, 2014. Objections and
requests for hearings must be received on or before February 9, 2015,
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-2013-0695, 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: Susan T. Lewis, 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 FFDCA section 408(g), 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-2013-0695 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
February 9, 2015. 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-2013-0695, 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/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.

II. Petition for Exemption

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10626) by
United Phosphorus, Inc., 630 Freedom Business Center Suite 402, King of
Prussia, PA 19406. The petition requested that 40 CFR 180.910 be
amended by establishing an exemption from the requirement of a
tolerance for residues of diisopropanolamine (CAS Reg. No. 110-97-4)
when used as an inert ingredient neutralizer or stabilizer in pesticide
formulations applied to growing crops or raw agricultural commodities
after harvest at not more than 10% by weight in a pesticide
formulation. That document referenced a summary of the petition
prepared by Pyxis Regulatory Consulting, the petitioner, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 for

diisopropanolamine including exposure resulting from the exemption
established by this action. EPA's assessment of exposures and risks
associated with diisopropanolamine follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by diisopropanolamine as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    The acute oral toxicity of diisopropanolamine is low. The acute
oral Lethal Dose (LD)50s in rats are all >2,000 milligram/
kilogram body weight (mg/kg bw). The acute dermal toxicity in rats and
rabbits is >8,000 mg/kg bw. Diisopropanolamine is an eye irritant based
on a primary eye irritation study in rabbits. Diisopropanolamine is
dermally irritating based on a primary skin irritation study in rabbits
with erythema after 24 hours and scaling after 8 days.
Diisopropanolamine is not a dermal sensitizer.
    Two subchronic oral toxicity studies using diisopropanolamine on
rats were available. In the 14-day study the no-observed-adverse-
effect-level (NOAEL) was 600 mg/kg/day in males and females based on
decreased body weight gain and relative kidney weight increases at
1,200 mg/kg/day. In the 90-day study the NOAEL was 100 mg/kg/day
(males) based on increased absolute and relative kidney weights at 500
mg/kg/day and 500 mg/kg/day (females) based on increases in absolute
and relative kidney weights at 1,000 mg/kg/day. There was also a 28-day
dermal toxicity study with diisopropanolamine in which the NOAEL was
the limit dose of 750 mg/kg/day for systemic effects.
    In a developmental toxicity study in rats with diisopropanolamine,
no observed adverse effects were seen at the limit dose of 1,000 mg/kg/
day for both maternal and developmental toxicity.
    In an in vitro mammalian cell gene mutation test, two bacterial
reverse mutation tests and an in vitro mammalian chromosomal aberration
test, results for mutagenicity and genotoxicity were negative for
diisopropanolamine.
    In a carcinogenicity study in rats dosed at 1% (~1,000 mg/kg/day)
diisopropanolamine for 94 weeks, no increase in incidence of tumors
over controls was observed under the conditions of the study.
    No immunotoxicity or neurotoxicity studies on diisopropanolamine
were available in the database. However, evidence of immunotoxicity or
neurotoxicity was not observed in the submitted studies.
    A dermal metabolism and dermal absorption study on
diisopropanolamine were provided. Based on the study, i.v.
administration of radioactive labeled diisopropanolamine rapidly
decreased in plasma and was undetectable at 18 and 24 hours. 96.8% of
the administered dose of diisopropanolamine was excreted in urine and
none was detectable in the feces. The dermal administration portion of
the study determined that ~20% was absorbed within 48 hours. Most of
the radiolabeled diisopropanolamine was excreted in urine. The
application site contained 49% of the applied diisopropanolamine.
Little diisopropanolamine was observed in the feces. The total
recovered dose was 69.2%. The absolute dermal absorption of
diisopropanolamine was calculated to be 12%.

B. 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 (U/SF) 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for diisopropanolamine
used for human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Diisopropanolamine for Use in Human Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population     An acute effect was not found in the database therefore an acute dietary
 including infants and children).                           assessment is not necessary.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 100 mg/kg/    Chronic RfD = 100    90-day oral toxicity_rat.
                                    day.                  mg/kg/day.          LOAEL = 500 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 1.0 mg/kg/     based on increase in relative and
                                   UFH = 10x...........   day.                 absolute kidney weight.
                                   FQPA SF = 1x........

Incidental oral short-term (1 to   NOAEL = 100 mg/kg/    LOC for MOE = 100..  90-day oral toxicity_rat.
 30 days).                          day.                                      LOAEL = 500 mg/kg/day based on
                                   UFA = 10x...........                        based on increase in relative and
                                   UFH = 10x...........                        absolute kidney weight.
                                   FQPA SF = 1x........
Incidental oral intermediate-term  NOAEL = 100 mg/kg/    LOC for MOE = 100..  90-day oral toxicity_rat.
 (1 to 6 months).                   day.                                      LOAEL = 500 mg/kg/day based on
                                   UFA = 10x...........                        increase in relative and absolute
                                   UFH = 10x...........                        kidney weight.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Dermal short- and intermediate-    Dermal exposure was not assessed because no systemic toxicity was identified
 term.                              at the limit dose of 750 mg/kg/day in a dermal toxicity study.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     oral study NOAEL =    LOC for MOE = 100..  90-day oral toxicity_rat.
 days).                             100 mg/kg/day                             LOAEL = 500 mg/kg/day based on
                                    (inhalation                                based on increase in relative and
                                    absorption rate =                          absolute kidney weight.
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation (1 to 6 months).......  oral study NOAEL =    LOC for MOE = 100..  90-day oral toxicity_rat.
                                    100 mg/kg/day                             LOAEL = 500 mg/kg/day based on
                                    (inhalation                                based on increase in relative and
                                    absorption rate =                          absolute kidney weight.
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Based on the lack of increased incidence of tumor formation compared to
                                    controls in a carcinogenicity study and the lack of mutagenicity,
                                    diisopropanolamine is considered not likely to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to diisopropanolamine, EPA considered exposure under the
proposed exemption from the requirement of a tolerance (40 CFR 180.910
as an inert ingredient used in pesticide formulations applied to
growing crops). EPA assessed dietary exposures from diisopropanolamine
in food as follows:
    Because an acute endpoint of concern was not identified, an acute
dietary exposure assessment is unnecessary. The chronic dietary
exposure assessment for this inert ingredient utilizes the Dietary
Exposure Evaluation Model Food Commodity Intake Database (DEEM-FCID),
Version 3.16, EPA, which includes food consumption information from the
U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, ``What We Eat in America'', (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. In the absence of
actual residue data, the inert ingredient evaluation is based on a
highly conservative model which assumes that the residue level of the
inert ingredient would be no higher than the highest established
tolerance for an active ingredient on a given commodity. Implicit in
this assumption is that there would be similar rates of degradation
between the active and inert ingredient (if any) and that the
concentration of inert ingredient in the scenarios leading to these
highest of tolerances would be no higher than the concentration of the
active ingredient. The model assumes 100 percent crop treated (PCT) for
all crops and that every food eaten by a person each day has tolerance-
level residues. A complete description of the general approach taken to
assess inert ingredient risks in the absence of residue data is
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts.'' (D361707, S.
Piper, 2/25/09) and can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for diisopropanolamine, a
conservative drinking water concentration value of 100 parts per
billion (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for parent compound. These values 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., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Diisopropanolamine is used as an inert ingredient in pesticide
products that could result in short- and intermediate-term residential
exposure,

and the Agency has determined that it is appropriate to aggregate
chronic exposure through food and water with short- and intermediate-
term residential exposures to diisopropanolamine. Possible routes of
exposure include dermal and/or inhalation exposure to outdoor lawn and
turf use (i.e. low pressure handwand, hose end sprayer and trigger
sprayers).
    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 diisopropanolamine to share a common mechanism of
toxicity with any other substances, and diisopropanolamine does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
diisopropanolamine 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 http://www.epa.gov/pesticides/cumulative.

D. 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 SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Fetal susceptibility was not
observed in developmental studies with rats administered
diisopropanolamine. Treatment with diisopropanolamine had no effect on
body weight gain or food consumption during the dosing period, kidney
or liver weights, gravid uterine weight, number of corpora lutea,
implantations or resorptions, percent pre- and post-implantation loss,
mean fetal weight or males or females, fetal sex ratio or the number of
viable fetuses. There were no statistically significant increases in
abnormalities (external, visceral or skeletal) in any treatment group
compared to the control.
    3. Conclusion. EPA has determined that reliable data show 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 diisopropanolamine contains the
following acceptable studies: Subchronic, developmental, and chronic/
carcinogenicity studies, several mutagenicity studies, and a dermal
metabolism and absorption study. No repeated dose inhalation toxicity
study is available in the database, however all inhalation MOEs, which
are based on the POD from the 90-day oral toxicity study, are greater
than 15,000. The Agency does not believe that any inhalation study
would provide a POD so substantially different from the POD in the 90-
day oral toxicity study to result in a risk of concern from inhalation
exposure; therefore, there is no need to include an additional
uncertainty factor to account for the lack of inhalation data.
    ii. There is no indication that diisopropanolamine is a neurotoxic
chemical. Although no neurotoxicity studies were available in the
database, no clinical signs of neurotoxicity were observed in the
available subchronic and chronic studies. Therefore, there is no need
for a developmental neurotoxicity study or additional UFs to account
for neurotoxicity.
    iii. Based on the discussion above, there is no concern that
diisopropanolamine results in increased susceptibility in the prenatal
developmental studies.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to diisopropanolamine in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
diisopropanolamine.

E. 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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
diisopropanolamine is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
diisopropanolamine from food and water will utilize 14.1% of the cPAD
for children 1-2 years old, the population group receiving the greatest
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Diisopropanolamine is currently used as an inert ingredient in
pesticide products that are registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to diisopropanolamine.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 2,600 for both
adult males and females respectively. EPA has concluded the combined
short-term aggregated food, water, and residential exposure results in
an aggregate MOE of 680 for children. Children's residential exposure
includes total exposures associated with contact with treated surfaces
(hand-to-mouth exposure). Because EPA's level of concern for
diisopropanolamine is a MOE of 100 or below, these MOEs are not of
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic

exposure to food and water (considered to be a background exposure
level). Diisopropanolamine is currently used as an inert ingredient in
pesticide products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to
diisopropanolamine.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 2,600 for adult males and females. EPA has concluded
the combined intermediate-term aggregated food, water, and residential
exposures result in an aggregate MOE of 690 for children. Children's
residential exposure includes total exposures associated with contact
with treated surfaces (hand-to-mouth exposure). Because EPA's level of
concern for diisopropanolamine is a MOE of 100 or below, these MOEs are
not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in adequate rodent carcinogenicity study,
diisopropanolamine is not expected to pose a cancer risk to humans.
    6. 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 diisopropanolamine residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for diisopropanolamine (CAS Reg. No.
110-97-4) when used as an inert ingredient (neutralizer or stabilizer)
in pesticide formulations applied to growing crops or raw agricultural
commodities after harvest at not more than 10% by weight in pesticide
formulations.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. 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 on the basis
of a petition under FFDCA section 408(d), such as the exemption 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 will submit 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: November 26, 2014.
Susan Lewis,
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.  180.910, add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
          Inert ingredients                        Limits                                Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Diisopropanolamine (CAS Reg. No. 110-  Not to exceed 10% by weight    Neutralizer or stabilizer.
 97-4).                                 of pesticide formulation.

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

[FR Doc. 2014-28955 Filed 12-9-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Notices]
[Page 94358]
[FR Doc No: 2016-30976]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-539-000]

Wildwood Solar I, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Wildwood Solar I, LLC`s application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 4, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: December 15, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-30976 Filed 12-22-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Notices]
[Pages 68007-68009]
[FR Doc No: 2021-26074]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93671; File No. SR-NSCC-2021-012]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of a Proposed
Rule Change To Make Certain Revisions and Clarifications to the Rules

November 24, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 15, 2021, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the clearing agency.
NSCC filed the proposed rule change pursuant to Section 19(b)(3)(A) of
the Act \3\ and Rule 19b-4(f)(4) thereunder.\4\ 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\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of modifications to NSCC's Rules
& Procedures (``Rules'') to (1) clarify defined terms related to the
onboarding agreements required to be provided by Settling Banks and AIP
Settling Banks; (2) incorporate in the Rules the affirmative
undertakings that Members currently make in onboarding membership
agreements; (3) clarify that Members shall appoint a duly authorized
representative in connection with their membership, and remove the
requirement that NSCC approve the form of power of attorney or
resolutions of the Member's board of directors that evidences such
authorization; (4) clarify NSCC's ability to rely on electronic
signatures on agreements and other documents provided to NSCC pursuant
to the Rules; and (5) incorporate into the Rules the governing law of
agreements and other documents provided to NSCC pursuant to the Rules,
as described in greater detail below.\5\
---------------------------------------------------------------------------

    \5\ Capitalized terms not defined herein are defined in the
Rules, available at https://www.dtcc.com/legal/rules-and-procedures.
NSCC has several types of membership with different access levels to
services, each described in Rule 2, id. For ease of description,
unless otherwise indicated by the context, the term ``Member'' is
used to refer to all membership categories.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency 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 these statements may be examined at the places
specified in Item IV below. The clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    NSCC is proposing amendments that would clarify, simplify and
improve the disclosures in the Rules, primarily related to onboarding
and other membership documentation between NSCC and its Members. NSCC,
along with its affiliates, The Depository Trust Company and Fixed
Income Clearing Corporation, has recently completed a review of the
templates of onboarding agreements and other documents that are
provided to NSCC in connection with a firm's application for membership
and the templates of agreements and documents Members may provide to
NSCC during the course of their membership pursuant to the Rules. In
connection with this review, NSCC is proposing to make certain
revisions and clarifications to the Rules.
    More specifically, the proposed rule changes would (1) clarify
defined terms related to the onboarding agreements required to be
provided by Settling Banks and AIP Settling Banks; (2) incorporate in
the Rules the affirmative undertakings that Members currently make in
onboarding membership agreements; (3) clarify that Members shall
appoint a duly authorized representative in connection with their
membership, and remove the requirement that NSCC approve the form of
power of attorney or resolutions of the Member's board of directors
that evidences such authorization; (4) clarify NSCC's ability to rely
on electronic signatures on agreements and other documents provided to
NSCC pursuant to the Rules; and (5) incorporate into the Rules the
governing law of agreements and other documents provided to NSCC
pursuant to the Rules, as described in greater detail below.
Proposed Revisions To Clarify the Defined Terms Related to Settling
Bank Agreements
    NSCC is proposing to revise Rule 1 (Definitions and Descriptions)
to clarify the defined terms related to the onboarding agreements
required to be provided by Settling Banks and AIP Settling Banks.
Settling Banks and AIP Settling Banks are types of NSCC membership that
undertake to perform settlement services on behalf of other Members.\6\
---------------------------------------------------------------------------

    \6\ Settling Bank and AIP Settling Bank membership types are
described in Sections 2(ii)(f) and (i) of Rule 2, id.
---------------------------------------------------------------------------

    Currently, the definition of ``Settling Bank'' in Rule 1 states
that these Members are party to both an ``Appointment of Settling
Bank'' and ``Settling Bank Agreement,'' and the definition of ``AIP
Settling Bank'' in Rule 1 states that these Members are party to both
an ``Appointment of AIP Settling Bank'' and ``AIP Settling Bank
Agreement,'' However, there are no separate definitions of the terms
``Appointment of Settling Bank,'' ``Settling Bank Agreement,''
``Appointment of AIP Settling Bank'' or ``AIP Settling Bank
Agreement.'' Furthermore, NSCC does not currently require these types
of Members to submit separate documents to evidence an appointment and
an agreement. Rather, under NSCC's current practice, Settling Banks and
AIP Settling Banks are required to be party to an effective agreement,
which includes both the appointment of the Settling Bank or AIP
Settling Bank and their affirmative undertaking to perform settlement
services for another Member that is also party to that agreement.
    Therefore, NSCC is proposing to amend the definitions of Settling
Bank and AIP Settling Bank in Rule 1 to refer only to a Settling Bank
Agreement and to add a definition of ``Settling Bank Agreement'' to
Rule 1, to clarify that this agreement includes both the appointment of
the Settling Bank or AIP Settling Bank and their affirmative
undertaking to perform settlement services for another Member that is
also party to that agreement. The proposed rule change would clarify
the definitions of these membership types and conform the description
of their membership documentation requirements in the Rules to NSCC's
current practice.
    In connection with this proposed change and also to conform the
Rules to NSCC's current practice, NSCC would also amend Rule 53
(Alternative Investment Product Services and Members) to refer to the
Settling Bank

Agreement among the required documentation to establish AIP Settling
Sub-Accounts in Section 1(d) and would revise a reference to an ``AIP
Settling Bank Agreement'' to refer to the proposed ``Settling Bank
Agreement'' in Section 7(h).
Proposed Revisions To Incorporate Member Undertakings Into the Rules
    NSCC is proposing to revise Section 1.E of Rule 2A (Initial
Membership Requirements) to incorporate affirmative undertakings that
Members currently make in their onboarding membership agreements.\7\
This section currently provides that an applicant for membership with
NSCC shall sign and deliver to NSCC an agreement under which the
applicant would agree to the affirmative undertakings that are listed
in this Section 1.E of Rule 2A.\8\ These undertakings include, for
example, to abide by the Rules and be bound by all the provisions
thereof, and to pay any amounts that become payable by the Member to
NSCC pursuant to the Rules.\9\
---------------------------------------------------------------------------

    \7\ Section 1.E of Rule 2A, id.
    \8\ Id.
    \9\ See Sections 1.E(e) and (h) of Rule 2A, id.
---------------------------------------------------------------------------

    To simplify and standardize the membership onboarding
documentation, NSCC is proposing to revise Section 1.E of Rule 2A to
state directly that Members agree to each of the undertakings listed in
that section. In connection with this proposed change, NSCC would
remove these undertakings from the template membership agreement, which
already provides that Members are bound by the Rules.
    In connection with this proposed change, NSCC would also make
identical revisions to statements within Section 1.E of Rule 2A
regarding the undertakings of other membership types, including (i)
footnotes 2 and 3 regarding Fund Members, (ii) a statement in
subsection 1 that refers to undertakings of Members that are Municipal
Securities Brokers' Brokers, (iii) a statement in subsection 2 that
refers to the onboarding obligations of Third Party Administrator
Members, Third Party Provider Members and Investment Manager/Agent
Members, and (iv) a statement regarding the onboarding obligations of
Settling Bank Only Members and Municipal Comparison Only Members.
Proposed Revisions to Requirements Related to Members' Authorized
Representatives
    NSCC is proposing to revise Section 2 of Rule 5 (General
Provisions), which describes Members' requirement to appoint an
authorized representative in connection with their membership with
NSCC.\10\ Currently, Section 2 of Rule 5 provides that a Member may
designate an authorized representative that is not either a general
partner or an officer of the Member by either a power of attorney or
resolutions of the Member's board of directors, and requires such power
of attorney and resolutions be in a form approved by NSCC.\11\ Section
2 of Rule 5 also requires Members to provide NSCC with the signatures
of individuals who are authorized representatives for purposes of
conducting business with NSCC.\12\
---------------------------------------------------------------------------

    \10\ Section 2 of Rule 5, id.
    \11\ Id.
    \12\ Id.
---------------------------------------------------------------------------

    In order to simplify the onboarding membership requirements, NSCC
is proposing to amend Section 2 of Rule 5 to clarify that Members must
appoint a duly authorized representative, and to remove references to a
power of attorney or resolutions of the Member's board of directors.
The proposed change would also remove the requirement that NSCC approve
the form of power of attorney or resolutions of the Member's board of
directors that evidences the due authorization of that representative.
Finally, NSCC is proposing to remove the requirement that Members
provide NSCC with the signatures of representatives who are authorized
to conduct business with NSCC.\13\
---------------------------------------------------------------------------

    \13\ Id.
---------------------------------------------------------------------------

Proposed Revisions to Rules Regarding NSCC's Reliance on Electronic
Signatures
    NSCC is proposing to revise Rule 32 (Signatures), which lists the
circumstances in which NSCC would rely on an electronic signature.\14\
The proposed revision to this Rule 32 would revise the rule to clarify
that NSCC may rely on an electronic signature with respect to any and
all agreements and other documents delivered pursuant to the Rules. In
connection with this change, NSCC would also remove reference to the
circumstances in which it would accept an electronic signature, to make
clear that NSCC would do so in any circumstances. The proposed
revisions would clarify and modernize the language in Rule 32, which
still refers to outdated modes of electronic communication, such as
telex, and would align the language in this Rule to language used in
the New York Electronic Signatures and Records Act.\15\
---------------------------------------------------------------------------

    \14\ Id.
    \15\ N.Y. State Tech. Law 304(2) (McKinney 2021).
---------------------------------------------------------------------------

Proposed Revisions to Rules Regarding Governing Law
    NSCC is proposing to revise Section 1 of Rule 38 (Governing Law and
Captions), which currently states that the Rules are governed by New
York law.\16\ The proposed change would revise Section 1 of Rule 38 to
include a statement that all agreements and other documents that are
entered into between NSCC and its Members are also governed by New York
law, unless otherwise expressly provided. Currently, agreements and
other documents entered into between NSCC and its Members either
include a governing law provision or are governed by New York law
through the application of both Section 1 of Rule 38, which provides
that the rights and obligations under the Rules are governed by New
York law, and the NSCC membership agreements, which provide that the
Rules (including Section 1 of Rule 38) govern the matters and
transactions between NSCC and its Members.
---------------------------------------------------------------------------

    \16\ Supra note 5.
---------------------------------------------------------------------------

    This proposed change would both clarify the governing law of the
agreements and other documents entered into between NSCC and its
Members pursuant to the Rules, and would allow NSCC to simplify those
documents by removing the governing law provisions in such documents.
2. Statutory Basis
    Section 17A(b)(3)(F) of the Act requires that the rules of NSCC be
designed to, among other things, promote the prompt and accurate
clearance and settlement of securities transactions.\17\ NSCC believes
the proposed changes are consistent with the requirements of Section
17A(b)(3)(F) of the Act because such changes would clarify and improve
the transparency of the Rules and would allow NSCC to simplify the
membership agreements and other documentation provided to it by Members
pursuant to the Rules.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    More specifically, the proposed changes would make clarifications
to the Rules regarding (i) defined terms related to the onboarding
agreements required to be provided by Settling Banks and AIP Settling
Banks; (ii) Members' duly authorized representatives in connection with
their memberships; and (iii) NSCC's ability to rely on electronic
signatures on agreements and other documents provided to it pursuant to
the Rules. The proposed changes would also update the Rules in order to
allow NSCC to simplify the onboarding and other

membership agreements and documents by incorporating in the Rules (1)
the governing law of agreements and other documents provided to NSCC
pursuant to the Rules; and (2) the affirmative undertakings that
Members currently make in onboarding membership agreements.
    By enhancing the clarity and transparency of the Rules, and
allowing NSCC to simplify the membership agreements and other
documents, the proposed changes would allow Participants to more
efficiently and effectively conduct their business in accordance with
the Rules, which NSCC believes would promote the prompt and accurate
clearance and settlement of securities transactions. As such, NSCC
believes that the proposed changes would be consistent with Section
17A(b)(3)(F) of the Act.\18\
---------------------------------------------------------------------------

    \18\ Id.
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    NSCC does not believe the proposed rule changes would impact
competition. The proposed rule changes would merely enhance the clarity
and transparency of the Rules and would simplify the documentation that
is provided to NSCC by Members pursuant to the Rules. Therefore, the
proposed changes would not affect NSCC's operations or the rights and
obligations of membership. As such, NSCC believes the proposed rule
changes would not have any impact on competition.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    NSCC has not received or solicited any written comments relating to
this proposal. If any written comments are received, they will be
publicly filed as an Exhibit 2 to this filing, as required by Form 19b-
4 and the General Instructions thereto.
    Persons submitting comments are cautioned that, according to
Section IV (Solicitation of Comments) of the Exhibit 1A in the General
Instructions to Form 19b-4, the Commission does not edit personal
identifying information from comment submissions. Commenters should
submit only information that they wish to make available publicly,
including their name, email address, and any other identifying
information.
    All prospective commenters should follow the Commission's
instructions on how to submit comments, available at https://www.sec.gov/regulatory-actions/how-to-submit-comments. General
questions regarding the rule filing process or logistical questions
regarding this filing should be directed to the Main Office of the
Commission's Division of Trading and Markets at
[email protected] or<PHONE_NUMBER>.
    NSCC reserves the right to not respond to any comments received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \19\ of the Act and paragraph (f) \20\ of Rule 19b-4
thereunder. 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.
---------------------------------------------------------------------------

    \19\ 15 U.S.C 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-NSCC-2021-012 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSCC-2021-012. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of NSCC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NSCC-2021-012 and should be submitted on
or before December 21, 2021.
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-26074 Filed 11-29-21; 8:45 am]
BILLING CODE 8011-01-P


Date:	February 7, 2013

Subject: 	Technical Approach for Mineral Wool MACT Floor Calculations

	40 CFR 63, Subpart DDD – Supplemental Proposal

	EPA Contract No. EP-D-11-084; EPA Work Assignment No. 1-07

	RTI Project No. 0213199.001.07

From: 		Cindy Hancy

		Dave Reeves

To: 		Susan Fairchild, EPA/OAQPS/SPPD/MMG

Introduction

Section 112 of the Clean Air Act (CAA) requires that the U.S.
Environmental Protection Agency (EPA) to establish National Emission
Standards for Hazardous Air Pollutants (NESHAP) for the control of the
hazardous air pollutants (HAP) emitted from both new and existing major
sources in a source category.  These standards must reflect the maximum
degree of reduction in the HAP emissions that is achievable.  The
minimum level of control is referred to as the “Maximum Achievable
Control Technology (MACT) floor.”  The method for determining the MACT
floor for a NESHAP is defined for both new and existing sources in CAA
section 112(d)(3).  For new sources, the MACT floor cannot be less
stringent than the emission control that is achieved in practice by the
best-controlled similar source.  For existing sources, the MACT floor
cannot be less stringent than the average emission limitation achieved
by the best-performing 12% of existing sources for source categories
with 30 or more sources, or the best-performing five sources for source
categories with fewer than 30 sources.

The purpose of this memorandum is to present the data, the methodology,
and the results of the MACT floor analysis for the Mineral Wool
Production NESHAP source category. This analysis is part of EPA's
obligation under CAA section 112(f)(2) and 112(d)(6) to conduct a
residual risk and technology review.  This MACT floor analysis uses data
collected from a voluntary, nationwide Information Collection Request
(ICR) of mineral wool manufacturers conducted by EPA in 2010.  Data on
process operations, emission controls, and air emissions data reported
by respondents to the ICR were compiled into a Microsoft Access data
base that serves as the data set used for this MACT floor analysis
(referred to in this memorandum as the “ICR data set”).

On November 25, 2011 EPA proposed revisions to the Mineral Wool
Production NESHAP, 40 CFR part 63, subpart DDD.  This memorandum
incorporates changes made since the November 2011 proposal to reflect
public comments regarding facility information and emissions data.

Background Information

The current Mineral Wool Production NESHAP was promulgated on June 1,
1999 and applies to existing, new, and reconstructed cupolas and curing
ovens at mineral wool production facilities that are major sources of
HAP emissions. The 1999 Mineral Wool Production NESHAP has particulate
matter (PM) emission limits for new and existing cupolas and carbon
monoxide (CO) limits for new cupolas.  The NESHAP also established
emission limits for formaldehyde from new and existing curing ovens.
Based on the 1999 NESHAP, these regulated pollutants currently serve as
surrogates for other HAPs as follows: PM serves as a surrogate for HAP
metals, CO for carbonyl sulfide (COS), and formaldehyde for phenol and
methanol.

The mineral wool production source category currently consists of 7
facilities in the US; combined, these 7 facilities operate 11 cupolas
and 3 curing ovens. The three facilities that operate curing ovens
produce both bonded and non-bonded mineral wool products.  One new
facility is currently under construction and is planned to operate 2
cupolas and 2 curing ovens. This new facility under construction is not
included in the MACT floor analysis (it is, however, included in the
cost analyses for this source category). In addition to curing ovens,
sources of HAP emissions associated with existing bonded product
manufacturing include collection operations. There were no emission
limits established for collection operations in the 1999 Mineral Wool
NESHAP. Bonded lines use HAP-containing binders that generate
formaldehyde, phenol, and methanol emissions from curing ovens and
collection sources. The processes and stack configurations of the curing
and collection operations vary at the three facilities operating bonded
lines. In the November 2011 proposal, EPA proposed subcategorizing
bonded lines by collection process type with separate MACT floor
emission limits for formaldehyde, phenol, and methanol. As part of the
public comments on the proposal, EPA received additional formaldehyde,
phenol, and methanol emissions (test) data from 2 of the 3 facilities
that operate bonded lines and revised the MACT floor calculations to
include this data. The EPA continues to propose subcategorizing bonded
lines by collection process and combined limits for curing oven and
collection operations.

The specific chemicals, compounds, or groups of compounds designated as
HAP are listed in CAA section 112(b). From this list, the following
additional HAPs were identified as being emitted from cupolas and were
proposed to be regulated for new and existing sources: carbonyl sulfide
(COS), hydrogen fluoride (HF), and hydrogen chloride (HCl). In the
November 2011 proposal, EPA developed MACT floor emission limits for
COS, HF, and HCl emissions from cupolas. As part of the public comments
on the proposed emission limits for cupolas, commenters provided
information regarding potential subcategorization approaches for
cupolas.  After reviewing this data, EPA has decided that two different
subcategorizations are appropriate when considering cupola emissions for
COS, HF, and HCl.

The docket for this rulemaking is (docket # EPA-HQ-OAR-2010-1041) has
been compiled at the EPA Air Docket and contains information that is
referenced in this and other memos.

MACT Floor Analysis - Subcategories

Under CAA section 112(d)(1), EPA has the discretion to “...distinguish
among classes, types, and sizes of sources within a category or
subcategory in establishing...” standards.  When separate
subcategories are established, a MACT floor is determined separately for
each subcategory.  To determine whether the mineral wool production
facilities warrant subcategorization for the MACT floor analysis, EPA
reviewed unit and process designs, operating information, and air
emissions data compiled in the ICR data set and other information
collected by the Agency for development of the NESHAP for this source
category.  Based on this review, EPA concluded that there are
significant design and operational differences in (1) the cupola design
and raw materials used; and (2) the collection operations at each of the
three facilities that operate a bonded line.

Cupolas

After the November 2011 proposal, industry submitted comments and
recommendations on cupola subcategorization. One commenters’
recommendation was to take into account the design differences between
open-top and closed-top cupolas. Open-top cupolas are open to the
atmosphere and are not under negative pressure at the top of the cupola
where raw materials and coke are typically charged.  Closed-top cupolas
are essentially completely enclosed at the top and are under negative
pressure to pull combustion air emissions directly from the vessel to
the appropriate pollution control devices.  In closed-top designs, raw
materials and coke also enter the cupola near the top, but a mechanical
device (i.e., door, gate, or other separation mechanism) keeps the
cupola virtually enclosed except for the brief moments when raw
materials or coke are charged. Open-top cupola designs can also be
exposed to the environmental elements; when it rains or snows, the
moisture goes through the top. As part of EPA’s evaluation of this
information and review of the various unit and process designs,
operating information, and air emissions data, EPA determined that the
design difference between open-top and closed-top cupolas warrant
subcategorization when determining COS MACT floors.

Additionally, EPA received raw material content information from 7
facilities producing mineral wool. Four facilities reported using slag
as a raw material and three reported only using minerals (rock) and coke
(e.g., “no slag”). Slag is a waste by-product and is
location-specific depending on the type of facility/process generating
the slag. Some slag has residual fluorides or chlorides which vary from
location to location and from process to process and can therefore
affect emissions of HF and HCl. In response to this information, EPA
decided to subcategorize cupolas based on slag usage for the purposes of
setting HF and HCl emission limits.

Collection Operations

The three proposed collection subcategories are listed below.

Vertical Collection:  In this design, the molten rock/slag mixture is
poured from the cupola spout onto a group of stainless steel drums
spinning in opposite directions.  The spinning drums form fine fibers
of the mineral mixture.  High air volume directs the fibers off the
fiberization spinners, toward a fast-moving porous vertical conveyor
belt. A strong vacuum is drawn on the opposite side of the belt, causing
the fibers to lie against the vertical belt as it moves upward.  At the
top of the conveyance, the belt travels around a curve, the vacuum is
released, and the fibers are removed on a second belt that conveys the
layer of binder-sprayed mineral wool fibers into the curing oven.

The vertical conveyer belt requires high volumes of air to be drawn
through the belt and results in the collection of a thin fiber layer
upon the belt.  In this design, ‘shot’, BB-sized black granules
that are high in iron (a result of using slag from the iron and steel
industry), fall out of the fiber layer.  The vertical design is used to
produce a specific type of mineral wool that is low in ‘shot’ and
may be used in the hydroponic gardening market, as well as, in a
specialized market of insulation products in which shot is undesirable.

Horizontal Collection: This process is similar to vertical collection,
except that the conveyor belt works with gravitational forces and
results in a thicker layer of mineral wool collected upon the horizontal
belt.  This method also requires lower air volume drawn through the
fiber layer than in the vertical design, and the ‘shot’ is not
selectively removed. The air stream is conducive to thermal oxidation at
the hottest part of the cupola exhaust stack or at the existing thermal
oxidizer on the curing oven.

Drum Collection:  In this design, fibers are drawn using a very high
volume air flow into the center of a rotating drum.  The sides of the
rotating drum have small holes through which the air flow may exit but
the fibers are caught.  The angle of the drum, the vacuum, and
centrifugal forces pull the fibers against the inside wall of the drum
and out the end. The entire drum is enclosed and the air flow may be
vented to the hottest part of the cupola exhaust stack or to an existing
thermal oxidizer on the curing oven.

MACT Floor Analysis Methodology

Existing Sources

A MACT floor analysis was completed for each regulated pollutant as
summarized in Table 1.

Table 1 – Summary Current RTR MACT Floor Analyses

	Existing Sources	New Sources

Cupolas

PM	Current PM limit will remain the same. No MACT floor analysis
performed.

CO	EPA removed the current CO limit since it was/is a surrogate for COS
in the 1999 NESHAP.

COS	EPA setting MACT floor limits and subcategorizing by closed top/open
top

HF	EPA setting MACT floor limits and subcategorizing by slag usage.

HCl

	Curing & Collection (combined)

Formaldehyde	EPA setting MACT floor limits and subcategorizing by
collection process

Phenol	EPA setting MACT floor limits and subcategorizing by collection
process

Methanol	EPA setting MACT floor limits and subcategorizing by collection
process

A MACT floor analysis was not performed for PM since EPA is not making
any changes to the current PM limits. The current formaldehyde limit
only applies to curing ovens. As previously mentioned, EPA is setting
new MACT emission limits for collection operations. Therefore, a MACT
floor analysis that includes both curing and collection was performed
for new and existing sources.  No current emission limits exist for COS,
phenol, or methanol; in order to develop emission limits for each
pollutant, a MACT floor analysis was performed for each of these
pollutants for new and existing sources.

The first step in the MACT floor analysis for each regulated source and
HAP was to rank each unit (for which emissions data was provided) by
emission level (lowest to highest) for each pollutant.  From this
ranking, a MACT floor pool of sources was identified for determining the
minimum control level allowed for the MACT floor, consistent with the
criteria defined for new and existing sources by CAA section 112(d)(3).
For the new source MACT floors, the best-controlled source was
identified for which there were individual source test run data in the
ICR data set.  For the existing source MACT floors, selection of the
MACT floor pool size (i.e., number of emission units to be included in
the determination of the average emission limitation value) was
determined on an individual unit category basis as described below.

Closed-top cupolas.   This category consists of 8 cupolas industry wide.
 EPA has COS emission data on 3 out of the 8 cupolas, therefore, the new
and existing source MACT floor for COS emissions consist of three
cupolas.

Open-top cupolas.   This category consists of 3 cupolas industry wide.
EPA has COS emission data on all 3 of these cupolas, therefore, the new
and existing source MACT floor for COS emissions consist of all of these
three cupolas.

Cupolas using slag as raw material. This category consists of 5 cupolas
industry wide.  EPA has HCl and HF emission data on 4 out of the 5
cupolas, therefore, the new and existing source MACT floor for HF and
HCl emissions consist of 4 cupolas.

Cupolas without slag in raw material.   This category consists of 6
cupolas industry wide.  EPA has HCl and HF emission data on 3 out of the
6 cupolas, therefore, the new and existing source MACT floor for HF and
HCl emissions consist of 3 cupolas.

Curing & Vertical Collection.  Currently, only one facility operates
this type of collection.  Formaldehyde, phenol, and methanol MACT floors
for new and existing sources were based on emission test runs for
combined curing and collection operations from this facility.

Curing & Horizontal Collection.  Currently, only one facility operates
this type of collection.  Formaldehyde, phenol, and methanol MACT floors
for new and existing sources were based on emission test runs for
combined curing and collection operations from this facility.

Curing & Drum Collection.  Currently, only one facility operates this
type of collection.  Formaldehyde, phenol, and methanol MACT floors for
new and existing sources were based on emission test runs for combined
curing and collection operations from this facility.

The next step in the MACT floor analysis was to account for data
variability in the calculations of the applicable MACT floor limits for
the subcategories using the data’s 99% upper prediction limit (UPL).
Specifically, the MACT floor limit was determined as the UPL calculated
with the Student’s t-test using the “TINV” function in Microsoft
Excel software.  The UPL approach has also been used in other EPA
rulemakings (e.g., NESHAP for Portland Cement, NSPS for
Hospital/Medical/Infectious Waste Incinerators, NESHAP for Industrial,
Commercial, Institutional Boilers and Process Heaters, and NESHAP for
Electric Generating Units) to account for variability in emissions data
for a specified level of confidence.  The level of confidence represents
the level of protection afforded to facilities whose emissions are in
line with the best performers.  For example, a 99% level of confidence
means that a facility whose emissions are consistent with the best
performers has one chance in 100 of exceeding the floor limit.  A
prediction interval for a single future observation (or an average of
several test observations) is an interval that will, with a specified
degree of confidence, contain the next (or the average of some other
pre-specified number) of randomly selected observation(s) from a
population.  In other words, the upper prediction limit estimates what
the upper bound of future values will be, based upon present or past
background samples taken.  The UPL consequently represents the value at
which we can expect the mean of future observations for the HAP
emissions to fall within a specified level of confidence, based upon the
results of an independent sample from the same population.  This method
accounts for the point-to-point variability in the data.

The form of the UPL equation differs somewhat depending upon the number
of data points and data distribution to which it is applied. Attachment
A includes a flow diagram that summarizes the UPL approaches used. To
this end, the data sets were evaluated for each HAP to ascertain whether
the data were normally distributed, or fit another type of distribution
(e.g., log normal distribution).  According to the Central Limit Theorem
(Durrett, 1996), when a data set includes 15 or more sources, the UPL is
based on the assumption that the data fit a normal distribution.  The
Central Limit Theorem states that regardless of the shape of the
original distribution, if the distribution has a finite mean (μ) and
variance (σ²), the sampling distribution of the mean approaches a
normal distribution with a mean of (μ) and a variance of σ²/N as N,
the sample size, increases (Durrett, 1996).

The mineral wool data sets used to calculate the MACT floor emission
limit for each pollutant all contained less than 15 sources. When the
sample size is smaller than 15 and the distribution of the data is
unknown, the Central Limit Theorem cannot be used to support the
normality assumption.  Statistical test of the kurtosis, skewness, and
goodness of fit test are then used to evaluate the normality assumption.
 The skewness statistic (S) characterizes the degree of asymmetry of a
given data distribution.  Normally distributed data have an S value of
0.  An S value that is greater (less) than 0 indicates that the data are
asymmetrically distributed with a right (left) tail extending towards
positive (negative) values.  The standard error of the skewness
statistic (SES) was also used in determining the normality of the data
distribution.  The kurtosis statistic (K) characterizes the degree of
peakedness or flatness of a given data distribution in comparison to a
normal distribution.  Normally distributed data have a K value of 0.  A
K value that is greater (less) than 0 indicates a relatively peaked
(flat) distribution.  The standard error of the kurtosis statistic (SEK)
was also used in determining the normality of the data distribution.

For each data set to which the UPL was applied (i.e., the separate data
sets for each HAP applicable to a source), the S and K values were
calculated using the reported test values.  If both kurtosis and
skewness tests indicate the data is normally distributed, the UPL was
calculated using the UPL pooled variance Equation 1.

   		Equation 1

Where:

  	=  the average (mean) of the best performing existing sources;

	t(p,df) 	=  the t statistic for a confidence level p, and df degrees of
freedom;

	s2	=  the pooled variance;

	n	=  the total number of test runs (all sources) used in the analysis;
and

	m	=  the number of (future) compliance test runs [for run-by-run data,
m=3].

Degrees of freedom calculated by:

 							    Equation 1a

Mean calculated by:

               Equation 1b

Pooled variance calculated by:

                                                      		    Equation 1c

If the kurtosis or skewness tests indicate the data was not normally
distributed, the data were log-transformed. Once the logs of all the
test runs were calculated, new kurtosis and skewness tests were
performed on the log-transformed data. If both kurtosis and skewness
tests indicated the log-transformed data were normally distributed, the
UPL can be calculated using the Equation 2.

                     Equation 2

where:

	μ	=  the average of the best performing existing sources;

  	=  the z statistic for a lognormal distribution at 99 percent;

 	=  the variance;

	n	=  the total number of test runs (all sources) used in the analysis;
and

	m	=  the number of (future) compliance test runs [for run-by-run data
m=3].

Mean is calculated by:

                        Equation 2a

Variance is calculated by:

           Equation 2b

If the raw data and the log-transformed data were not normally
distributed and n ≥13, the UPL was calculated using the UPL pooled
variance with skewness adjustment in Equation 3.  Note this adjustment
cannot be used if the number of individual runs is less than 13.

    Equation 3

where:

  	=  the average of the best performing existing sources;

	t(p,df) 	=  the t statistic for a confidence level p, and df degrees of
freedom;

	s2	=  the pooled variance;

	n	=  the total number of test runs (all sources) used in the analysis;

	m	=  the number of (future) compliance test runs [for run-by-run data
m=3]; and

	Skew	=  the skewness of the test runs used in the analysis.

If the raw data and the log-transformed data were not normally
distributed and n was less than 13 the UPL was calculated using the UPL
pooled variance in Equation 1, but instead of using the Excel TINV
formula to find the t statistic t(p,df), a trial and error method was
used to find the t static that gives a 99 percent confidence level by
correcting the probability values  (p) using Equation 4.

Corrected Probability = P0(t) + Skewness x Pλ3(t) – Kurtosis x
Pλ4(t) + λ32xP λ3/2(t)       Equation 4

Adjustment for Below Detection Level Emissions Data

Prior to calculating the UPLs, test runs with results that were below
detection level (BDL) were identified.  If a data set contained any BDL
values, the UPL was calculated using BDL values as reported in the test
report. The calculated floor or emissions limit was then compared to
three times the RDL values provided by EPA. If the three times the RDL
was less than the calculated floor or emissions limit (e.g., calculated
from the UPL), we conclude that measurement variability was adequately
addressed and the calculated floor or emissions limit would need no
adjustment. If, on the other hand, the value equal to three times the
RDL were greater than the UPL, we concluded that the calculated floor or
emissions limit does not account entirely for measurement variability
and used the three times RDL value instead. The RDL for each pollutant
was determined using data from tests of all the best performers for all
of the final regulatory subcategories (i.e., pooled test data). If no
BDL values were included in the pollutant data set for a particular unit
type, these steps were not performed.

MACT Floor Analysis Results

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 existing source MACT floor values determined for the Mineral Wool
Production source category.

Table 2. Summary of MACT floors for the Mineral Wool Production Source
Category

Process

            - HAP

Total Sources in Industry	Mean of Sources Used in UPL Analysis	99% UPL
Calculated for New and Existing Sources

Open-Top Cupolas

	COS	3	3.9	6.8

Closed-Top Cupolas

	COS	10	1.0	3.4

Cupolas using Slag

	HF	5	0.058	0.16

HCl

0.053	0.21

Cupolas without Slag

	HF	6	0.033	0.13

HCl

0.055	0.43

Curing & Drum Collection

	Formaldehyde

1	0.10	0.18

Phenol

0.62	1.3

Methanol

0.21	0.48

Curing & Vertical Collection

	Formaldehyde

1	1.1	2.7

Phenol

0.37	0.74

Methanol

0.44	1.0

Curing & Horizontal Collection

	Formaldehyde

1	0.05	0.054

Phenol

0.01	0.15

Methanol

0.01	0.022

Attachment A

DRAFT 3-1-11

  PAGE   \* MERGEFORMAT  10


[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Notices]
[Pages 36769-36770]
[FR Doc No: 2013-14543]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP13-969-000]

Rockies Express Pipeline LLC; Notice of Petition for Declaratory
Order

    Take notice that on June 6, 2013, pursuant to Rule 207(a)(2) of the
Commission's Rules of Practices and Procedure, 18 CFR 385.207(a)(2),
Rockies Express Pipeline LLC, filed a petition seeking a declaratory
order ruling that the ``most favored nations'' or ``MFN'' provisions
contained in Rockies Express' negotiated rate agreements with its
Foundation and Anchor Shippers will not be triggered by certain
potential transactions, as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and

Procedure (18 CFR 385.211, 385.214). Protests will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Any person
wishing to become a party must file a notice of intervention or motion
to intervene, as appropriate. Such notices, motions, or protests must
be filed on or before the comment date. On or before the comment date,
it is not necessary to serve motions to intervene or protests on
persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on July 12, 2013.

    Dated: June 12, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-14543 Filed 6-18-13; 8:45 am]
BILLING CODE 6717-01-P