[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Rules and Regulations]
[Pages 21472-21478]
[FR Doc No: 2016-08282]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0449; FRL-9944-11]

1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl] propoxy]-; 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 1,2-propanediol, 3-[3-[1, 3, 3, 3-
tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg.
No. 70280-68-1) when used as an inert ingredient (antifoaming agent) in
pesticide formulations applied to growing crops at a maximum
concentration not to exceed 5% by weight. Exponent, on behalf of ISK
Biosciences 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 1,2-propanediol,
3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl]
propoxy]-.

DATES: This regulation is effective April 12, 2016. Objections and
requests for hearings must be received on or before June 13, 2016, 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-2014-0449, 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 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. To access the OCSPP test guidelines referenced in this
document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

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-2014-0449 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 13, 2016. 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-2014-0449, 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 April 6, 2015 (80 FR 18327) (FRL-9924-
00), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10699) by
Exponent, on behalf of ISK Biosciences, 7470 Auburn Road, Suite A,
Concord, OH 44077. The petition requested that 40 CFR 180.920 be
amended by establishing an exemption from the requirement of a
tolerance for residues of 1,2-propanediol, 3-[3-[1, 3, 3, 3-
tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg.
No. 70280-68-1) when used as an inert ingredient (antifoaming agent) in
pesticide formulations applied to growing crops at a maximum
concentration not to exceed 10% in formulation. That document
referenced a summary of the petition prepared by Exponent, the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the limitation on the maximum concentration in the pesticide
formulation from 10% to 5%. This limitation is based on the Agency's
risk assessment which can be found at http://www.regulations.gov in
document, ``1,2-Propanediol, 3-[3-[1,3,3,3,3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-; Human health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pre-harvest Pesticide Products Under 40 CFR 180.920'' in
docket ID number EPA-HQ-OPP-2014-0449.

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 1,2-propanediol, 3-[3-[1, 3, 3,
3-tetramethyl-1-

[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with 1,2-propanediol, 3-
[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl]
propoxy]- 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 1,2-propanediol, 3-[3-[1, 3, 3, 3-
tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- 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.
    There is currently limited data available for 1,2-propanediol, 3-
[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-
disiloxanyl]propoxy]-. The Agency received three studies specifically
testing 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-: acute oral toxicity,
acute dermal toxicity, and an Ames assay. Those studies showed that
1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-
disiloxanyl]propoxy]- was non-toxic via acute oral and acute dermal
exposures and was negative for mutagenicity. To assess the remaining
potential toxicity of 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-, the Agency relied on
data for a suitable cluster of structurally related linear short chain
siloxane (Si-2 to Si-5) compounds. Based on the similar structures and
physicochemical properties of these compounds to 1,2-propanediol, 3-[3-
[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-,
which primarily differ only in the number of siloxane units, the Agency
has determined that the toxicological properties of these compounds is
representative of the toxicity of 3-[3-[1,3,3,3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-. The Agency has also
determined that these data adequately address the physicochemical,
mammalian metabolism, mammalian toxicological, and environmental fate
endpoints of 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-.
    Oral repeat dose toxicity studies are available for structurally
similar linear short chain siloxane chemicals, for durations ranging
from 28 days up to one year in rats, rabbits, and dogs. The lowest
NOAELs were in the 25 milligram/kilogram/day (mg/kg/day) range for two
28-day oral repeat dose rat studies and a 90-day dog study. LOAELs for
these studies were based mainly on liver effects which were present in
all of these studies.
    Dermal repeated dose toxicity studies are available for two of the
structurally similar linear short chain siloxane compounds. A 28-day
dermal toxicity study in rats and rabbits showed no adverse effects up
to limit dose of 1,000 mg/kg/day. The NOAEL was 1,000 mg/kg/day; the
highest dose tested in both studies.
    Inhalation repeated dose toxicity studies are available for three
of the structurally similar linear short chain siloxane compounds. Both
28-day and 90-day rat inhalation studies are available as well as a
one-year chronic inhalation study. The lowest inhalation NOAEL was 3.9
milligrams per Liter (mg/L) in a 90-day study, equivalent to a dose of
greater than 1,000 mg/kg/day, a limit dose value.
    A carcinogenicity study is available on one structurally-related
short chain siloxane compound. An increase incidence of Leydig cell
tumors (LCTs) in males was observed at all doses. However, due to the
high background incidence of LCTs in Fischer 344 rats, this effect has
been determined to not be treatment-related. Renal tubular adenomas and
carcinomas were also observed in the study but are attributable to male
rat specific alpha-2[mu]-globulin mediated nephrotoxicity and therefore
not relevant to cancer risk concerns in humans. Genotoxicity studies on
1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-
disiloxanyl]propoxy]- and structurally-related compounds were negative
for genotoxic effects. A DEREK (structure-activity modeling) analysis
was conducted and identified no structural alerts for possible
carcinogenicity among the linear short chain siloxane compounds.
Therefore, based on the lack of human-relevant carcinogenicity in the
available study, and the results of the genotoxicity studies and DEREK
analysis, 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- is not expected to be
carcinogenic.
    Reproductive and developmental toxicity studies with linear short
chain siloxane compounds demonstrated no adverse effects at doses at or
below limit dose levels. No evidence of immunotoxicity or neuro
toxicity at doses below the limit dose was observed in the available
studies for the structurally related linear short chain siloxane (Si-2
to Si-5) compounds at up to limit dose levels.
    There are currently no publically-available metabolism studies for
1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-
disiloxanyl]propoxy]-, however, the expected mammalian metabolic
pathways which may be involved in the degradation of 1,2-propanediol,3-
[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-
include a combination of ether hydrolysis followed by [szlig]-oxidation
of the carbon chain followed by methyl oxidation of the silyl methyl
groups. Methyl oxidation would result in the formation of a mixture of
primary and alcohol metabolites. The more polar primary alcohol
functionalities can both be conjugated and excreted directly or further
oxidized to form a mixture of more polar carboxylic acid metabolites
that are readily conjugated and excreted.
    Specific information on the studies received and the nature of the
adverse effects caused by 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- as well as the NOAEL and
the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document, ``1,2-Propanediol,3-[3-[1,3,3,3-
tetraamethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-; Human
Health Risk Assessment and Ecological Effects Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as an
Inert Ingredient in Pre-harvest Pesticide Products Under 40 CFR
180.920'' in docket ID number EPA-HQ-OPP-2014-0449.

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 the NOAEL and the
LOAEL are identified. 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for 1,2-propanediol, 3-[3-
[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl]
propoxy]- used for human risk assessment is shown in Table 1 of this
unit.
    The 28-day studies in rats the NOAEL was 25 mg/kg/day with a LOAEL
of 250 mg/kg/day based on based on increases in absolute liver weights,
hepatocellular hypertrophy and protoporphyrin accumulation with
associated bile duct proliferation and periportal chronic inflammation.
A 90-day dog study had a NOAEL of 24 mg/kg/day with a LOAEL of 77 mg/
kg/day based on increased relative liver weight in females and lower
relative testes weight in males with slight testicular atrophy or
hypoplasia in males. A NOAEL of 25 mg/kg/day was selected for use as
the endpoint for dietary exposure in this risk assessment. An
additional uncertainty factor of 3X was applied for the use of shorter
term study for a chronic risk assessment.
    Dermal and inhalation exposure endpoints were not selected as there
were no adverse effects observed up to limit dose levels in both rat
and rabbit dermal and inhalation toxicity studies.

   Table 1--Summary of Toxicological Doses and Endpoints for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
                [(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- for Use in Human Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                 effects
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Acute dietary (All populations)......  An acute effect was not found in the database therefore an acute dietary
                                        assessment is not necessary.
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Chronic dietary (All populations)....  NOAEL= 25 mg/kg/day....  Chronic RfD = 0.08 mg/   28-Day oral toxicity
                                       UFA = 10x..............   kg/day.                  study-rat LOAEL = 250
                                       UFH = 10x..............  cPAD = 0.08 mg/kg/day..   mg/kg/day based on
                                       FQPA SF = 3x...........                            protoporphyrin
                                                                                accumulation in the
                                                                                liver.
Incidental oral short-term (1 to 30    NOAEL= 25 mg/kg/day....  LOC for MOE = 300......  28-Day oral toxicity
 days).                                UFA = 10x..............                            study-rat LOAEL = 250
                                       UFH = 10x..............                            mg/kg/day based on
                                       FQPA SF = 3x...........                            protoporphyrin
                                                                                accumulation in the
                                                                                liver.
Incidental oral intermediate-term (1   NOAEL= 25 mg/kg/day....  LOC for MOE = 300......  28-Day oral toxicity
 to 6 months).                         UFA = 10x..............                            study-rat LOAEL = 250
                                       UFH = 10x..............                            mg/kg/day based on
                                       FQPA SF = 3x...........                            protoporphyrin
                                                                                accumulation in the
                                                                                liver.
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Not likely to be carcinogenic to humans based on the lack of increased
                                        incidence of tumor formation compared to controls in the 1-year
                                        carcinogenicity study, lack of mutagenicity, and no structural alerts
                                        for genotoxicity or carcinogenicity identified in a qualitative
                                        structure activity relationship (SAR) database, DEREK.
----------------------------------------------------------------------------------------------------------------
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). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). UFS = use of a short-term study for long-term risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from 1,2-propanediol, 3-[3-
[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl]
propoxy]- in food as follows:
    i. Acute Exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide chemical, if a
toxicological study has indicated the possibility of an effect of
concern occurring as a result of a 1-day or single exposure. No such
effects were identified in the toxicological studies for 1,2-
propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-
disiloxyanyl] propoxy]-; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
    ii. Chronic exposure. 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.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- does not pose a cancer
risk to humans. Therefore, a dietary exposure assessment for the
purpose of assessing cancer risk is unnecessary.
    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 1,2-propanediol, 3-
[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl]
propoxy]-, 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).
    Residential use patterns are possible for pesticide products
containing 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-. Residential exposure
could occur via the dermal and inhalation routes of exposure. However,
there are no concerns for dermal or inhalation exposure because no
effects were seen in dermal or inhalation toxicity studies up to the
limit dose. Incidental oral exposure for children is possible either by
hand-to-mouth or object-to-mouth ingestion resulting from contact with
treated surfaces.
    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 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- to share a common
mechanism of toxicity with any other substances, and 1,2-propanediol,
3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl]
propoxy]- does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- 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 Food Quality
Protection Act Safety Factor (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. Although some adverse
reproductive effects were observed in the inhalation developmental/
reproductive toxicity studies, these effects were at dose levels far in
excess of the clear NOAEL established in the oral reproductive and
developmental screening study and the regulatory doses used in the risk
assessment were selected to be protective of these effects.
    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 3x to account for the use of a subchronic study
to derive a chronic reference dose. That decision is also based on the
following findings:
    i. Although only limited data on 1,2-propanediol, 3-[3-[1, 3, 3, 3-
tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is
available, the Agency has reliable data based on the structurally
related linear short chain siloxane (Si-2 to Si-5) compounds to
adequately characterize the toxicity and assess the risk from dietary
exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.
    ii. There is no indication that 1,2-propanediol, 3-[3-[1, 3, 3, 3-
tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is a
neurotoxic chemical at doses below the limit dose and there is no need
for a developmental neurotoxicity study or additional uncertainty
factors (UFs) to account for neurotoxicity.
    iii. There is no indication that 1,2-propanediol, 3-[3-[1, 3, 3, 3-
tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is a
immunotoxic chemical and there is no need for a immunotoxicity study or
additional UFs to account for immunotoxicity.
    iv. As discussed in Unit IV.D.2., there is no need to retain the
FQPA 10x to address any concern for potential increased susceptibility
in infants and children from prenatal or postnatal exposure to 1,2-
propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-
disiloxyanyl] propoxy]-.
    v. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on a highly conservative model that assumes 100 percent crop treated
(PCT) for all crops and that every food eaten by a person each day has
residues of inert ingredient equivalent to the residue level of the
highest established tolerance for an active ingredient on a given
commodity. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to 1,2-propanediol,
3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl]
propoxy]- in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by 1,2-propanediol, 3-[3-[1,
3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.

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,
1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-
1-disiloxyanyl] propoxy]- 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
1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-
1-disiloxyanyl] propoxy]- from food and water will utilize 88.3% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure. Based on the explanation in this unit regarding
residential use patterns, chronic residential exposure to residues of
1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-
1-disiloxyanyl] propoxy]- is not expected.
    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).
    1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- may be used as an inert
ingredient in pesticide products that would result in short-term
residential exposure. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Although short-term
residential exposure is possible, there was no endpoint of concern
identified in both dermal and inhalation toxicity studies. However the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
for children. EPA has concluded the combined short-term aggregated
food, water, and residential exposures results in an aggregate MOE of
334 for children. Children's aggregate MOE combines average food and
water exposure from the chronic dietary exposure with residential
exposure associated with contact with treated lawns (hand-to-mouth +
object-to-mouth). As the level of concern is for MOEs that are lower
than 300, 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).
    1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- may be used as an inert
ingredient in pesticide products that would result in intermediate-term
residential exposure. Intermediate-term risk is assessed based on
intermediate-term residential exposure plus chronic dietary exposure.
Although intermediate-term residential exposure is possible, there was
no endpoint of concern identified in both dermal and inhalation
toxicity. However the Agency has determined that it is appropriate to
aggregate chronic exposure through food and water with intermediate-
term residential exposures for children. EPA has concluded the combined
intermediate-term aggregated food, water, and residential exposures
results in an aggregate MOE of 342 for children. Children's aggregate
MOE combines average food and water exposure from the chronic dietary
exposure with residential exposure associated with contact with treated
lawns (hand-to-mouth + object-to-mouth). As the level of concern is for
MOEs that are lower than 300, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit
IV.A., EPA does not expect 1,2-propanediol, 3-[3-[1, 3, 3, 3-
tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- 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 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Although EPA is establishing a limitation on the amount of 1,2-
propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-
disiloxyanyl] propoxy]- that may be used in pesticide formulations, an
analytical enforcement methodology is not necessary for this exemption
from the requirement of tolerance. The limitation will be enforced
through the pesticide registration process under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. EPA will not register any pesticide for sale or distribution for
use on growing crops with concentrations of 1,2-propanediol, 3-[3-[1,
3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-
exceeding 5% by weight of the formulation.

B. Revisions to Petitioned-For Tolerances

    Based upon an evaluation of the data included in the petition, EPA
is establishing an exemption from the requirement of a tolerance for
residues of 1,2-propanediol 3-[3-[1, 3, 3, 3-tetramethyl-1-
[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- when used in pesticide
formulations as an inert ingredient (antifoaming agent), not to exceed
5% by weight of the formulation, instead of the 10% limit requested.
The basis for this revision can be found at http://www.regulations.gov
in document, ``1,2-Propanediol,3-[3-[1,3,3,3-tetraamethyl-1-
[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-; Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pre-harvest Pesticide Products Under 40 CFR 180.920'' in
docket ID number EPA-HQ-OPP-2014-0449.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for 1,2-propanediol, 3-[3-[1, 3, 3, 3-
tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg.
No. 70280-68-1) when used as an inert ingredient (antifoaming agent) in
pesticide formulations applied to growing crops at a maximum
concentration not to exceed 5% by weight in formulation.

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: March 31, 2016.
G. Jeffrey Herndon,
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.  180.920, add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

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

                                                  * * * * * * *
1,2-Propanediol, 3-[3-[1, 3, 3, 3-         Not to exceed 5% by weight    Antifoaming agent.
 tetramethyl-1-[(trimethylsilyl)oxy]-1-     of pesticide formulation.
 disiloxyanyl] propoxy]- (CAS Reg. No.
 70280-68-1).

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

[FR Doc. 2016-08282 Filed 4-11-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Rules and Regulations]
[Pages 45862-45864]
[FR Doc No: 2015-18739]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31029; Amdt. No. 3654]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective August 3, 2015. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of August 3, 2015.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC, 20590-
0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA).
    For information on the availability of this material at NARA, call
202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420) Flight Technologies and Procedures
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic

depiction on charts printed by publishers of aeronautical materials.
Thus, the advantages of incorporation by reference are realized and
publication of the complete description of each SIAP contained on FAA
form documents is unnecessary. This amendment provides the affected CFR
sections, and specifies the SIAPs and Takeoff Minimums and ODPs with
their applicable effective dates. This amendment also identifies the
airport and its location, the procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on July 17, 2015.
John Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By Amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
        AIRAC date            State             City               Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
20-Aug-15................  CA           Livermore..........  Livermore Muni.....       5/7014     06/11/15  This NOTAM, published in TL 15-17, is hereby
                                                                                rescinded in its entirety.
20-Aug-15................  OK           Clinton............  Clinton-Sherman....       5/0435     07/06/15  ILS OR LOC RWY 17R, Amdt 7A.
20-Aug-15................  MO           Jefferson City.....  Jefferson City            5/0449     07/06/15  ILS OR LOC RWY 30, Amdt 5B.
                                                              Memorial.
20-Aug-15................  NY           Dunkirk............  Chautauqua County/        5/0564     07/06/15  VOR RWY 24, Amdt 8.
                                                              Dunkirk.
20-Aug-15................  NY           Dunkirk............  Chautauqua County/        5/0571     07/06/15  RNAV (GPS) RWY 15, Orig.
                                                              Dunkirk.
20-Aug-15................  NY           Dunkirk............  Chautauqua County/        5/0572     07/06/15  RNAV (GPS) RWY 6, Orig.
                                                              Dunkirk.
20-Aug-15................  NY           Dunkirk............  Chautauqua County/        5/0573     07/06/15  RNAV (GPS) RWY 24, Orig.
                                                              Dunkirk.
20-Aug-15................  NY           Dunkirk............  Chautauqua County/        5/0574     07/06/15  RNAV (GPS) RWY 33, Orig.
                                                              Dunkirk.
20-Aug-15................  NY           Dunkirk............  Chautauqua County/        5/0575     07/06/15  VOR RWY 6, Amdt 3.
                                                              Dunkirk.
20-Aug-15................  MA           Beverly............  Beverly Muni.......       5/0582     07/06/15  RNAV (GPS) RWY 16, Amdt 1A.
20-Aug-15................  MA           Beverly............  Beverly Muni.......       5/0583     07/06/15  RNAV (GPS) RWY 34, Orig.
20-Aug-15................  MA           Beverly............  Beverly Muni.......       5/0584     07/06/15  LOC RWY 16, Amdt 7.
20-Aug-15................  MA           Beverly............  Beverly Muni.......       5/0585     07/06/15  RNAV (GPS) RWY 27, Orig-A.
20-Aug-15................  MA           Beverly............  Beverly Muni.......       5/0586     07/06/15  VOR RWY 16, Amdt 5.
20-Aug-15................  TN           amden..............  Benton County......       5/1575     06/24/15  RNAV (GPS) RWY 22, Orig-A.
20-Aug-15................  NM           Carlsbad...........  Cavern City Air           5/1690     07/09/15  ILS RWY 3, Amdt 4C.
                                                              Trml.

20-Aug-15................  MI           Iron Mountain        Ford...............       5/3036     07/06/15  NDB RWY 1, Orig.
                                         Kingsford.
20-Aug-15................  IN           Gary...............  Gary/Chicago Intl..       5/4354     07/06/15  RNAV (GPS) Y RWY 12, Amdt 1.
20-Aug-15................  OH           Port Clinton.......  Erie-Ottawa Intl...       5/4483     07/06/15  RNAV (GPS) RWY 27, Amdt 1.
20-Aug-15................  OH           Port Clinton.......  Erie-Ottawa Intl...       5/4484     07/06/15  NDB RWY 27, Amdt 14.
20-Aug-15................  TX           Houston............  West Houston.......       5/4496     07/06/15  RNAV (GPS) RWY 15, Amdt 1A.
20-Aug-15................  SC           Greenville.........  Greenville Downtown       5/5829     07/07/15  RNAV (GPS) RWY 1, Orig-B.
20-Aug-15................  SC           Greenville.........  Greenville Downtown       5/5830     07/07/15  NDB RWY 1, Amdt 22B.
20-Aug-15................  SC           Greenville.........  Greenville Downtown       5/5831     07/07/15  ILS Y OR LOC Y RWY 1, Orig.
20-Aug-15................  SC           Greenville.........  Greenville Downtown       5/5834     07/07/15  ILS Z OR LOC Z RWY 1, Amdt 30.
20-Aug-15................  SC           Greenville.........  Greenville Downtown       5/5839     07/07/15  RNAV (GPS) RWY 19, Amdt 1.
20-Aug-15................  SC           Greenville.........  Greenville Downtown       5/5862     07/07/15  RNAV (GPS) RWY 10, Amdt 1.
20-Aug-15................  ID           Salmon.............  Lemhi County.......       5/7282     06/11/15  RNAV (GPS)-D, Orig-A.
20-Aug-15................  MN           South St Paul......  South St Paul Muni-       5/8151     07/06/15  NDB-B, Amdt 4.
                                                              Richard E Fleming
                                                              Fld.
20-Aug-15................  MN           South St Paul......  South St Paul Muni-       5/8159     07/06/15  RNAV (GPS) RWY 34, Amdt 1.
                                                              Richard E Fleming
                                                              Fld.
20-Aug-15................  MN           South St Paul......  South St Paul Muni-       5/8164     07/06/15  LOC RWY 34, Amdt 1A.
                                                              Richard E Fleming
                                                              Fld.
20-Aug-15................  AL           Dothan.............  Dothan Rgnl........       5/9070     07/06/15  RNAV (GPS) RWY 36, Amdt 1A.
20-Aug-15................  AL           Dothan.............  Dothan Rgnl........       5/9072     07/06/15  VOR RWY 14, Amdt 4A.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-18739 Filed 7-31-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Notices]
[Pages 51236-51237]
[FR Doc No: 2017-23941]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-8-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of
Application

    Take notice that on October 16, 2017, Transcontinental Gas Pipe
Line Company, LLC (Transco), P.O. Box 1396, Houston, Texas 77251 filed
in Docket No. CP17-10-000 an abbreviated application pursuant to
section 7(b) of the Natural Gas Act (NGA) and Part 157 of the
Commission's Regulations, requesting retroactive authorization to
abandon certain natural gas facilities, including gas supply metering
and regulating facilities and pipeline laterals, that are located in
Louisiana, Mississippi, Texas, New Jersey, and offshore Louisiana and
are no longer in service. Transco is requesting this abandonment
authorization to clarify the regulatory status of facilities that were
previously erroneously abandoned pursuant to Transco's automatic
blanket certificate authority, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection.
    The filing may also be viewed on the web at http://www.ferc.gov
using the eLibrary link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at

[email protected] or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Bela
Patel, Senior Regulatory Analyst,<PHONE_NUMBER>, P.O. Box 1396,
Houston, Texas 77251.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit five copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit original and five copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on November 20, 2017.

    Dated: October 30, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-23941 Filed 11-2-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Notices]
[Page 18505-18507]
[DOCID:fr12ap10-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0165]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Draft
Guidance for Industry on Guidances for the Validation of Analytical
Methods Used in Residue Depletion Studies (VICH GL49); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (208) entitled
``Draft Guidance for Industry on Guidances for the Validation of
Analytical Methods Used in Residue Depletion Studies,'' (VICH GL49).
This draft guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This draft
VICH guidance document is intended to provide a general description of
the criteria that has been found to be acceptable to the European Union
(EU), Japan, the United States, Australia, New Zealand, and Canada for
the validation of analytical methods used in veterinary drug residue
studies.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 12, 2010.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests.
    Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit

electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary
Medicine, (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(208) entitled ``Draft Guidance for Industry on Guidances for
the Validation of Analytical Methods Used in Residue Depletion
Studies,'' VICH GL49. In recent years, many important initiatives have
been undertaken by regulatory authorities and industry associations to
promote the international harmonization of regulatory requirements. FDA
has participated in efforts to enhance harmonization and has expressed
its commitment to seek scientifically based harmonized technical
procedures for the development of pharmaceutical products. One of the
goals of harmonization is to identify and then reduce differences in
technical requirements for drug development among regulatory agencies
in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the EU, Japan, and the United States. The VICH is a
parallel initiative for veterinary medicinal products. The VICH is
concerned with developing harmonized technical requirements for the
approval of veterinary medicinal products in the EU, Japan, and the
United States, and includes input from both regulatory and industry
representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal
Health Institute, the Japanese Veterinary Pharmaceutical Association,
the Japanese Association of Veterinary Biologics, and the Japanese
Ministry of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH Steering Committee
meetings.

II. Draft Guidance on the Validation of Analytical Methods Used in
Residue Depletion Studies

    The VICH Steering Committee held a meeting on November 5, 2009, and
agreed that the draft guidance document entitled ``Draft Guidances for
the Validation of Analytical Methods Used in Residue Depletion
Studies,'' (VICH GL49) should be made available for public comment.
This draft VICH guidance document is one of a series developed to
facilitate the mutual acceptance of residue chemistry data for
veterinary drugs used in food-producing animals. This guidance was
prepared after consideration of the current requirements for evaluating
veterinary drug residues in the EU, Japan, the United States,
Australia, New Zealand, and Canada.
    During the veterinary drug development process, residue depletion
studies are conducted to determine the concentration of the residue or
residues present in the edible products (tissues, milk, eggs, or honey)
of animals treated with veterinary drugs. This information is used in
regulatory submissions around the world. Submission of regulatory
methods (postapproval control methods) and the validation requirements
of the regulatory methods are usually well defined by various
regulatory agencies worldwide and may even be defined by law.
Consequently, it has been difficult to harmonize the procedures used
for validation of these methods. However, the residue studies are
generally conducted before the regulatory methods have been completed.
Often the in-house validated residue methods provide the framework for
the methods submitted for regulatory monitoring. Harmonization of the
validation requirements for methodology used during residue studies and
submitted to the regulatory agencies in support of the maximum residue
limits and withdrawal periods should be achievable. It is the intent of
this document to describe a validation procedure that is acceptable to
the regulatory bodies of the EU, Japan, the United States, Australia,
New Zealand, and Canada for use in the residue depletion studies. This
validated method may continue on to become the ``regulatory method''
but that phase of the process will not be addressed in any detail in
these guidances.
    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Significance of Guidance

    This draft guidance, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    The draft guidance, when finalized, will represent the agency's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in sections 1-3 of this guidance have been
approved under OMB control no. 0910-0032.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/

default.htm or http://www.regulations.gov.

    Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8230 Filed 4-9-10; 8:45 am]
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[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Proposed Rules]
[Page 44438]
[DOCID:fr08au07-20]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Parts 35 and 37

[Docket Nos. RM05-17-002 and RM05-25-002]

Preventing Undue Discrimination and Preference in Transmission
Service

Issued July 27, 2007.
AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice allowing Post-Technical Conference comments.

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

SUMMARY: On July 30, 2007, the Federal Energy Regulatory Commission
convened a technical conference addressing issues related to lead-time
for undesignated network resources in order to make firm third-party
sales and the eligibility of on-system seller's choice and system sales
to be designated as network resources. This notice provides an
opportunity for interested parties to file written comments in relation
to the issues that were the subject of the technical conference.

FOR FURTHER INFORMATION CONTACT: Thomas E. Dautel, Office of Energy
Markets and Reliability, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Notice Allowing Post-Technical Conference Comments

August 1, 2007.
    Pursuant to the Commission's June 26, 2007 Order in this
proceeding, 119 FERC ] 61,322 (2007), a staff technical conference was
convened on Monday, July 30, 2007, from 9 a.m. to 3 p.m. at the offices
of the Federal Energy Regulatory Commission. The technical conference
addressed issues related to the minimum lead-time for undesignating
network resources in order to make firm third-party sales and the
eligibility of on-system seller's choice and system sales to be
designated as network resources, as clarified in Order No. 890.\1\
---------------------------------------------------------------------------

    \1\ Preventing Undue Discrimination and Preference in
Transmission Service, Order No. 890, 72 FR 12266 (March 15, 2007),
FERC Stats. & Regs. ] 31,241 at PP 1483 and 1557-59 (2007), reh'g
pending.
---------------------------------------------------------------------------

    All interested persons are invited to file written comments no
later than August 13, 2007 in relation to the issues that were the
subject of the technical conference. Those filing comments are
specifically encouraged to identify alternative ways to address the
minimum lead-time for undesignating network resources in order to make
firm third-party sales and the eligibility of on-system seller's choice
and system sales to be designated as a network resource without
impairing the ability of transmission providers to calculate available
transfer capability (ATC) or unduly discriminating among classes of
transmission customers. Comments may either be filed on paper or
electronically via the eFiling link on the Commission's Web site at
http://www.ferc.gov.

    For further information, please contact Tom Dautel at (202) 502-
6196 or e-mail at<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E7-15401 Filed 8-7-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Proposed Rules]
[Pages 86525-86527]
[FR Doc No: 2020-28839]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1989-0008; FRL-10018-19-OLEM]

Proposed Deletion From the National Priorities List

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notice of intent.

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

SUMMARY: The Environmental Protection Agency (EPA) is issuing a Notice
of Intent to partially delete the North Penn--Area 6 site from the
National Priorities List (NPL) and requests public comments on this
proposed action. The NPL, promulgated pursuant to the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) of
1980, as amended, is an appendix of the National Oil and Hazardous
Substances Pollution Contingency Plan (NCP). The EPA and the
Commonwealth of Pennsylvania, through its designated state agency, have
determined that all appropriate response actions under CERCLA, other
than operations and maintenance, monitoring and five-year reviews,
where applicable, have been completed. However, this proposed deletion
would not preclude future actions under Superfund.

DATES: Comments regarding this proposed listing must be submitted on or
before January 29, 2021.

ADDRESSES: EPA has established a docket for this action under the
Docket Identification number included in Table 1 in the SUPPLEMENTARY
INFORMATION section of this document. Submit your comments, identified
by the appropriate Docket ID number, by one of the following methods:
     https://www.regulations.gov. Follow on-line instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. The EPA may publish any comment received
to its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
     Email: Table 2 in the SUPPLEMENTARY INFORMATION section of
this document provides an email address to submit public comments for
the proposed deletion action.
    Instructions: Direct your comments to the Docket Identification
number included in Table 1 in the SUPPLEMENTARY INFORMATION section of
this document. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through https://www.regulations.gov or email. The https://www.regulations.gov website
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through https://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of

encryption, and be free of any defects or viruses.
    Docket: EPA has established a docket for this action under the
Docket Identification included in Table 1 in the SUPPLEMENTARY
INFORMATION section of this document. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through https://www.regulations.gov or
in hard copy at the corresponding Regional Records Center. Location,
address, and phone number of the Regional Records Center follows.
    Regional Records Center:
     Region 3 (DE, DC, MD, PA, VA, WV), U.S. EPA Records
Center, 1650 Arch Street, Mail code 3SD2, Philadelphia, PA 19103; 215/
814-3024.
    The EPA is temporarily suspending Regional Records Centers for
public visitors to reduce the risk of transmitting COVID-19.
Information in these repositories, including the deletion docket, has
not been updated with hardcopy or electronic media. For further
information and updates on EPA Docket Center services, please visit us
online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID.

FOR FURTHER INFORMATION CONTACT:
     Huu Ngo, U.S. EPA Region 3 (DE, DC, MD, PA, VA, WV),
<EMAIL_ADDRESS>215/814-3187.
     Chuck Sands, U.S. EPA Headquarters<EMAIL_ADDRESS>
703/603-8857.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Intended Partial Site Deletion

I. Introduction

    EPA is issuing a Notice of Intent to partially delete one site from
the National Priorities List (NPL) and requests public comments on this
proposed action. The NPL constitutes Appendix B of 40 CFR part 300
which is the NCP, which EPA created under section 105 of the CERCLA
statute of 1980, as amended. EPA maintains the NPL as those sites that
appear to present a significant risk to public health, welfare, or the
environment. Sites on the NPL may be the subject of remedial actions
financed by the Hazardous Substance Superfund (Fund). This partial
deletion is proposed in accordance with 40 CFR 300.425(e) and is
consistent with the Notice of Policy Change: Partial Deletion of Sites
Listed on the National Priorities List. 60 FR 55466, November 1, 1995.
As described in 300.425(e)(3) of the NCP, a portion of a site deleted
from the NPL remains eligible for Fund-financed remedial action if
future conditions warrant such actions.
    EPA will accept comments on the proposal to partially delete this
site for thirty (30) days after publication of this document in the
Federal Register.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III of this document discusses procedures
that EPA is using for this action. Section IV of this document
discusses the portion of the site proposed for deletion and
demonstrates how it meets the deletion criteria, including reference
documents with the rationale and data principally relied upon by the
EPA to determine that the Superfund response is complete.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the state, whether any of the following criteria have
been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. all appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. the remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-
year reviews to ensure the continued protectiveness of remedial actions
where hazardous substances, pollutants, or contaminants remain at a
site above levels that allow for unlimited use and unrestricted
exposure. EPA conducts such five-year reviews even if a site is deleted
from the NPL. EPA may initiate further action to ensure continued
protectiveness at a deleted site if new information becomes available
that indicates it is appropriate. Whenever there is a significant
release from a site deleted from the NPL, the deleted site may be
restored to the NPL without application of the hazard ranking system.

III. Deletion Procedures

    The following procedures apply to the partial deletion of the site
in this proposed rule:
    (1) EPA consulted with the respective state before developing this
Notice of Intent for partial deletion.
    (2) EPA has provided the state 30 working days for review of this
proposed action prior to publication of it today.
    (3) In accordance with the criteria discussed above, EPA has
determined that no further response is appropriate.
    (4) The state, through their designated state agency, has concurred
with the proposed partial deletion action.
    (5) Concurrently, with the publication of this Notice of Intent for
partial deletion in the Federal Register, a notice is being published
in a major local newspaper of general circulation near the site. The
newspaper announces the 30-day public comment period concerning the
Notice of Intent for partial deletion.
    (6) The EPA placed copies of documents supporting the proposed
partial deletion in the deletion docket, made these items available for
public inspection, and copying at the Regional Records Center
identified above.
    If comments are received within the 30-day comment period on this
document, EPA will evaluate and respond accordingly to the comments
before making a final decision to partially delete the site. If
necessary, EPA will prepare a Responsiveness Summary to address any
significant public comments received. After the public comment period,
if EPA determines it is still appropriate to partially delete the site,
the EPA will publish a final Notice of Partial Deletion in the Federal
Register. Public notices, public submissions and copies of the
Responsiveness Summary, if prepared, will be made available to
interested parties and included in the site information repositories
listed above.
    Deletion of a portion of a site from the NPL does not itself
create, alter, or revoke any individual's rights or obligations.
Deletion of a portion of a site from the NPL does not in any way

alter EPA's right to take enforcement actions, as appropriate. The NPL
is designed primarily for informational purposes and to assist EPA
management. Section 300.425(e)(3) of the NCP states that the deletion
of a site from the NPL does not preclude eligibility for future
response actions, should future conditions warrant such actions.

IV. Basis for Partial Site Deletion

    The site to be partially deleted from the NPL, the location of the
site, and docket number with information including reference documents
with the rationale and data principally relied upon by the EPA to
determine that the Superfund response is complete are specified in
Table 1. The NCP permits activities to occur at a deleted site or that
media or parcel of a partially deleted site, including operation and
maintenance of the remedy, monitoring, and five-year reviews. These
activities for the site are entered in Table 1, if applicable, under
Footnote such that; 1 = site has continued operation and maintenance of
the remedy, 2 = site receives continued monitoring, and 3 = site five-
year reviews are conducted.

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
            Site name               City/county, state          Type              Docket No.         Footnote
----------------------------------------------------------------------------------------------------------------
North Penn--Area 6...............  Lansdale, PA.......  Partial............  EPA-HQ-SFUND-1989-0         1, 2, 3
                                                                              008.
----------------------------------------------------------------------------------------------------------------

    Table 2 includes a description of the area, media or Operable Units
(OUs) of the NPL site proposed for partial deletion from the NPL, and
an email address to which public comments may be submitted if the
commenter does not comment using https://www.regulations.gov.

                                                     Table 2
________________________________________________________
                                             Media/parcels for partial
                Site name                             deletion               Email address for public comments
________________________________________________________
North Penn_Area 6......................  1.66-acres soil and groundwater  [email protected]
                                           of the Second Administrative
                                           Parcel, 135 East Hancock
                                           Street.
----------------------------------------------------------------------------------------------------------------

    EPA maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment.
Deletion from the NPL does not preclude further remedial action.
Whenever there is a significant release from a site deleted from the
NPL, the deleted site may be restored to the NPL without application of
the hazard ranking system. Deletion of a site from the NPL does not
affect responsible party liability in the unlikely event that future
conditions warrant further actions.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Oil pollution, Penalties, Reporting and
recordkeeping requirements, Superfund, Water pollution control, Water
supply.

    Authority: 33 U.S.C. 1251 et seq.; 42 U.S.C. 9601-9657; E.O.
13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR
54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR,
1987 Comp., p. 193.

    Dated: December 18, 2020.
Dana Stalcup,
Acting Office Director, Office of Superfund Remediation and Technology
Innovation.
[FR Doc. 2020-28839 Filed 12-29-20; 8:45 am]
BILLING CODE 6560-50-P