[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7745-7747]
[FR Doc No: 2018-03613]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0115]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff--Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Principle

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collection of information concerning
class II special controls for an automated blood cell separator device
operating by centrifugal or filtration separation principle.

DATES: Submit either electronic or written comments on the collection
of information by April 23, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to

the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-0115 for ``Guidance for Industry and FDA Staff--Class II
Special Controls Guidance Document: Automated Blood Cell Separator
Device Operating by Centrifugal or Filtration Separation Principle.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry and FDA Staff--Class II Special Controls Guidance
Document: Automated Blood Cell Separator Device Operating by
Centrifugal or Filtration Separation Principle, OMB Control Number
0910-0594--Extension

    Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), FDA
may establish special controls, including performance standards,
postmarket surveillance, patient registries, guidelines, and other
appropriate actions it believes necessary to provide reasonable
assurance of the safety and effectiveness of the device. The special
control guidance serves as the special control for the automated blood
cell separator device operating by centrifugal or filtration separation
principle intended for the routine collection of blood and blood
components (Sec.  864.9245 (21 CFR 864.9245)).
    For currently marketed products not approved under the premarket
approval process, the manufacturer should file with FDA for 3
consecutive years an annual report on the anniversary date of the
device reclassification from class III to class II or on the
anniversary date of the 510(k) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360(k)) clearance. Any subsequent change to
the device requiring the submission of a premarket notification in
accordance with section 510(k) of the FD&C Act should be included in
the annual report. Also, a manufacturer of a device determined to be
substantially equivalent to the centrifugal or filtration-based
automated cell separator device intended for the routine collection of
blood and blood components should comply with the same general and
special controls.
    The annual report should include, at a minimum, a summary of
anticipated and unanticipated adverse events that have occurred and
that are not required to be reported by manufacturers under Medical
Device Reporting (MDR) (part

803 (21 CFR part 803)). The reporting of adverse device events
summarized in an annual report will alert FDA to trends or clusters of
events that might be a safety issue otherwise unreported under the MDR
regulation. The report should also include any subsequent change to the
preamendments class III device requiring a 30-day notice in accordance
with 21 CFR 814.39(f).
    Reclassification of this device from class III to class II relieves
manufacturers of the burden of complying with the premarket approval
requirements of section 515 of the FD&C Act (21 U.S.C. 360e) and may
permit small potential competitors to enter the marketplace by reducing
the burden. Although the special control guidance recommends that
manufacturers of these devices file with FDA an annual report for 3
consecutive years, this would be less burdensome than the current
postapproval requirements under 21 CFR part 814, subpart E, including
the submission of periodic reports under 21 CFR 814.84.
    Collecting or transfusing facilities, the intended users of the
device, and the device manufacturers have certain responsibilities
under the Federal regulations. For example, collecting or transfusing
facilities are required to maintain records of any reports of
complaints of adverse reactions (21 CFR 606.170), while the device
manufacturer is responsible for conducting an investigation of each
event that is reasonably known to the manufacturer and evaluating the
cause of the event (Sec.  803.50(b) (21 CFR 803.50(b)). In addition,
manufacturers of medical devices are required to submit to FDA
individual adverse event reports of death, serious injury, and
malfunctions (Sec.  803.50).
    In the special control guidance document, FDA recommends that
manufacturers include in their three annual reports a summary of
adverse reactions maintained by the collecting or transfusing facility
or similar reports of adverse events collected.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                         Reporting activity                             Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Annual Report......................................................               3                1                3                5               15
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on FDA records, there are approximately three manufacturers
of automated blood cell separator devices. We estimate that the
manufacturers will spend approximately 5 hours preparing and submitting
the annual report. The total burden hours are reduced from previous
collections due to a decrease in the number of manufacturers.
    Other burden hours required for Sec.  864.9245 are reported and
approved under OMB control number 0910-0120 (premarket notification
submission 510(k), 21 CFR part 807, subpart E), and OMB control number
0910-0437 (MDR, part 803).

    Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03613 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Rules and Regulations]
[Page 5624-5630]
[DOCID:fr07fe07-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0918; FRL-8110-8]

Avermectin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of the insecticide avermectin B1 and its
delta-8,9-isomer in or on bulb onions. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of this pesticide on bulb onions. This regulation establishes a
maximum permissible level for residues of avermectin in this food
commodity. The tolerance expires and is revoked on December 31, 2009.

DATES: This regulation is effective February 7, 2007. Objections and
requests for hearings must be received on or before April 9, 2007, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0918. All documents in the
docket are listed on the regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) 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 in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail 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.
Potentially

affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0918 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before April 9, 2007.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0918, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a time-limited tolerance for combined
residues of the insecticide avermectin B1 and its delta-8,9-
isomer in or on bulb onions at 0.005 parts per million (ppm). This
tolerance expires and is revoked on December 31, 2009. EPA will publish
a document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the 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 the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Avermectin on Bulb Onions and FFDCA
Tolerances

    EPA has authorized under FIFRA section 18 the use of avermectin on
bulb onions for control of thrips in Colorado. Avermectin also goes by
the name abamectin, but the two names describe the same chemical. The
CAS number is the same for both (71751-41-2). After having reviewed the
materials submitted in support of the emergency exemption request, EPA
concurred with the applicant that emergency conditions existed for this
State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of avermectin in or on bulb
onions. In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary time-limited
tolerance under section 408(l)(6) of the FFDCA would be consistent with
the safety standard and with FIFRA section 18. Consistent with the need
to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing this tolerance without notice and
opportunity for public comment as provided in section 408(l)(6) of the
FFDCA. Although this tolerance expires and is revoked on December 31,
2009,

under section 408(l)(5) of the FFDCA, residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
bulb onions after that date will be lawful, provided the pesticide is
applied at a time and in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by this time-limited
tolerance at the time of that application. EPA will take action to
revoke this time-limited tolerance earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
    Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
avermectin meets EPA's registration requirements for use on bulb onions
or whether a permanent tolerance for this use would be appropriate.
Under these circumstances, EPA does not believe that this time-limited
tolerance serves as a basis for registration of avermectin by a State
for special local needs under FIFRA section 24(c). Nor does this time-
limited tolerance serve as the basis for any State other than Colorado
to use this pesticide on this crop under section 18 of FIFRA without
following all provisions of EPA's regulations implementing FIFRA
section 18 as identified in 40 CFR part 166. For additional information
regarding the emergency exemption for avermectin, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the FFDCA, 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
avermectin and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for a time-limited
tolerance for combined residues of avermectin B1 and its
delta-8,9-isomer in or on bulb onions at 0.005 ppm. EPA's assessment of
the dietary exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for avermectin used for human risk assessment can be found in
a tolerance document published on February 16, 2005, titled
``Avermectin B1 and its delta-8,9-isomer; Pesticide
Tolerance'' (70 FR7876; FRL-7695-7).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. EPA previously
established tolerances (40 CFR 180.449) for the combined residues of
avermectin B1 and its delta-8,9-isomer, in or on a variety
of raw agricultural commodities. Risk assessments were conducted by EPA
to assess dietary exposures from avermectin in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 and 1998 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: A Tier 3, acute probabilistic
dietary exposure assessment was conducted for all supported food uses
and drinking water. Acute anticipated residues for many foods were
derived using market basket survey, new field trial studies and food
handling establishment request. Estimated concentrations of avermectin
in drinking water were incorporated directly into the acute assessment.
    ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM/FCID which incorporates food consumption
data as reported by respondents in the USDA 1994-1996 and 1998
Nationwide CSFII, and accumulated exposure to the chemical for each
commodity. Percent crop treated and anticipated residues refinements
were used.
    A Tier 2 chronic dietary exposure assessment was conducted for the
general U.S. population and various population subgroups. The
assumptions of the assessment were anticipated residue estimates,
percent of crop treated (PCT) estimates for most of the commodities,
and default DEEM processing factors when necessary. Estimated
concentrations of avermectin in drinking water were incorporated
directly into the chronic assessment.

    iii. Cancer. EPA did not perform a cancer aggregate exposure
assessment because avermectin B1 is classified as a Group E
chemical and is ``not likely to be carcinogenic to humans.''
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide chemicals that have been measured in food.
If EPA relies on such information, EPA must pursuant to section
408(f)(1) require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. For the present action, EPA will issue such
Data Call-Ins for information relating to anticipated residues as are
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA
section 408(f)(1). Such data call-ins will be required to be submitted
no later than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT.
    The Agency used PCT information as follows: Almonds 21%; avocado
20%; balsam pear 1%; cantaloupe 7%; casabas 1%; chayote fruit 1%;
Chinese waxgourd 1%; cotton 3%; cress (garden, upland) 1%; cucumber 1%;
grape 6%; hops 82%; honeydew melon 1%; plum 1%; pumpkin 1%; squash 1%;
strawberry 44%; walnut 2%; watermelon 7%.
    The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which avermectin may
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for avermectin in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of avermectin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Tier II screening models PRZM (Pesticide Root Zone Model) and EXAMS
(Exposure Analysis Modeling System) were used to determine estimated
surface water concentrations of avermectin based on the modeled
scenario of one seed treatment to cucumbers followed by 3 aerial
applications at a 7-day interval in Florida. This use of abamectin
represents the worst case potential contribution of abamectin to
drinking water when considering currently registered uses, including
this one.
    The full PRZM/EXAMS distribution was used for the acute dietary
assessment, and the 1-in-10 year annual mean concentration of 0.244 ppm
was used for chronic dietary estimates. Modeled estimates of drinking
water concentrations were directly entered into the dietary exposure
model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Avermectin is currently registered for use on the following
residential non-dietary sites: Residential lawn application for fire
ant control and residential indoor crack and crevice application for
cockroaches and ants. These registered residential uses may result in
short-term to intermediate-term exposures; however, based on current
use patterns, long-term exposure (6 or more months of continuous
exposure) to avermectin is not expected. Adults may be exposed through
handling the pesticide and both adults and children may be exposed
through contact with treated areas following application. Accordingly,
handler and post-application exposures were assessed for two major
categories of residential avermectin use which are considered to
represent the reasonable high-end residential exposure potential:
Granular baits used to treat lawns, and indoor crack and crevice dust
products.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of

toxicity, EPA has not made a common mechanism of toxicity finding as to
avermectin and any other substances and avermectin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has not assumed that
avermectin has 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 the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations
and procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

C. Safety Factor for Infants and Children

     In general. Section 408 of the FFDCA provides that EPA shall apply
an additional tenfold 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 that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
    For avermectin B1 EPA retained the default 10X factor
based on the following combination of factors:
     There is residual uncertainty due to a data gap for a
developmental neurotoxicity study (DNT), as well as data gaps for acute
and subchronic neurotoxicity studies. These studies are required
because avermectin B1 has been shown to be neurotoxic, with
multiple neurotoxic clinical signs (including head and body tremors and
limb splay) seen in multiple studies with multiple species.
     For several species, the dose-response curve appears to be
steep.
     Severe effects were seen at the LOAELs in several studies
(death, neurotoxicity, and developmental toxicity). Although increased
susceptibility of the young was observed in several studies, the degree
of concern with that susceptibility was judged to be low. Increased
susceptibility (qualitative and/or quantitative) was seen in prenatal
developmental toxicity studies in CD-1 mice and rabbits following in
utero exposure to avermectin B1. There was also an increase
in quantitative and qualitative susceptibility in the rat reproductive
toxicity study. The concern for susceptibility seen in the
developmental study with rabbits and in the reproductive toxicity study
in the rat is low because the lowest NOAEL obtained (0.12 milligrams/
kilogram/day (mg/kg/day)) was used as the basis for the cRfD and other
non-dietary risk assessment scenarios, which is protective of all of
the developmental/offspring effects seen in those studies. Similarly,
the concern for susceptibility seen at the LOAEL in the CD-1 mouse
developmental toxicity study is low, since the NOAEL in the rat
reproductive toxicity study is lower than the dose at which effects
were seen in the CD-1 mouse.

D. Aggregate Risks and Determination of Safety.

    The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.

    More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EDWCs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs. The
risk assessment for avermectin used in this tolerance document uses
this approach of incorporating water exposure directly into the dietary
exposure analysis.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to avermectin will occupy 42% of the aPAD for the U.S. population, 7%
of the aPAD for females 13 years and older, 89% of the aPAD for all
infants less than 1-year old and 71% of the aPAD for children 1-2 years
old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
avermectin from food will utilize 9% of the cPAD for the U.S.
population, 21% of the cPAD for all infants less than 1 year old and
21% of the cPAD for children 1-2 years old. Based on the use pattern,
chronic residential exposure to residues of avermectin is not
expected..
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Avermectin is currently registered for use(s) that could result in
short-term and intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic food and
water and short-term and intermediate-term exposures for avermectin.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food,
water and residential exposures aggregated result in the following
aggregate MOEs: 2,900 for the U.S. population, and 1,700 for children
1-2 years old. These aggregate MOEs do not exceed the Agency's level of
concern of 1,000 for aggregate exposure to food, water and residential
uses.
    4. Aggregate cancer risk for U.S. population. EPA has not performed
a cancer aggregate risk assessment because avermectin has been
classified as a Group E chemical by the Agency and is ``not likely to
be carcinogenic to humans.''
    5. Determination of safety. Based on these risk assessments which
indicate that all avermectin risks are below the Agency's levels of
concern, EPA concludes that there is a reasonable certainty that no
harm will result to the general population, and to infants and children
from aggregate exposure to avermectin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft.

Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    There are no CODEX residue limits for residues of avermectin on
onions, therefore, harmonization is not an issue.

VI. Conclusion

    Therefore, the time-limited tolerance is established for combined
residues of the insecticide avermectin B1 (a mixture of
avermectins containing greater than or equal to 80% avermectin
B1a (5-O-demethyl avermectin A1) and less than or
equal to 20% avermectin B1b (5-O-demethyl-25-de(1-
methylpropyl)-25-(1-methylethyl) avermectin A1)) and its
delta-8,9-isomer, in or on bulb onions at 0.005 ppm. The time-limited
tolerance expires and is revoked on December 31, 2009.

VII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section
408 of the FFDCA. 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 rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerance 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. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. 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 this final rule in the Federal Register. This final
rule 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: January 24, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.449 is amended by adding text after the heading in
paragraph (b) to read as follows:

Sec.  180.449  Avermectin B1 and its delta-8,9-isomer;
tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of avermectin B1 and it delta-
8,9-isomer, in connection with use of the pesticide under section 18
emergency exemptions granted by EPA. The tolerances are specified in
the following table. The tolerances will expire on the dates specified
in the table.

----------------------------------------------------------------------------------------------------------------
          Commodity                     Parts per million                    Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Onion, bulb                                                 0.005                                       12/31/09
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E7-2003 Filed 2-6-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55709-55710]
[FR Doc No: 2018-24328]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2434-007; ER10-2436 007; ER10-2467 007; ER17-
1666-003.
    Applicants: Fenton Power Partners I, LLC, Hoosier Wind Project,
LLC, Red Pine Wind Project, LLC, Wapsipinicon Wind Project, LLC.
    Description: Second Supplement to June 27, 2018 Triennial Market
Power Update for the Central Region of the EDFR Sellers.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5296.
    Comments Due: 5 p.m. ET 11/21/18.

    Docket Numbers: ER10-3285-002; ER10-3181-003; ER17-177-001.
    Applicants: UGI Utilities Inc., UGI Development Company, UGI Energy
Services, LLC.
    Description: Notice of Non-Material Change in Status of the UGI MBR
Companies.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5324.
    Comments Due: 5 p.m. ET 11/21/18.

    Docket Numbers: ER16-1833-004.
    Applicants: Sempra Gas & Power Marketing, LLC.
    Description: Compliance filing: Sempra Gas & Power Marketing, LLC
Compliance Filing to be effective 11/1/2018.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5164.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER16-2516-001.
    Applicants: Arizona Public Service Company.
    Description: Compliance filing: Rate Schedule No. 284--Delaney
Interconnection Agreement to be effective 10/31/2016.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5098.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-240-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Letter Agreement Southern
California Renewable Partners, LLC--Vision Wind to be effective 10/17/
2018.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5236.
    Comments Due: 5 p.m. ET 11/21/18.

    Docket Numbers: ER19-241-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: Q3 2018 Quarterly Filing of
City and County of San Francisco's WDT SA (SA 275) to be effective 9/
30/2018.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5238.
    Comments Due: 5 p.m. ET 11/21/18.

    Docket Numbers: ER19-243-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3498 Kennett Board of Public
Works NITSA NOA to be effective 10/1/2018.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5246.
    Comments Due: 5 p.m. ET 11/21/18.

    Docket Numbers: ER19-244-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to the Tariff, OA
and RAA RE: Seasonal DR Registration Aggregation to be effective 1/1/
2019.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5261.
    Comments Due: 5 p.m. ET 11/21/18.

    Docket Numbers: ER19-245-000.
    Applicants: Southwest Power Pool, Inc.

    Description: Sec.  205(d) Rate Filing: 3500 Paragould Light Water
and Cable to be effective 10/1/2018.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5263.
    Comments Due: 5 p.m. ET 11/21/18.

    Docket Numbers: ER19-246-000.
    Applicants: Llano Estacado Wind, LLC.
    Description: Sec.  205(d) Rate Filing: LEW MBR Tariff Update Change
in Status 2018.10.31 to be effective 11/1/2018.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5289.
    Comments Due: 5 p.m. ET 11/21/18.

    Docket Numbers: ER19-248-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA SA No.
4918; Queue No. AC2-072 to be effective 1/30/2018.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5065.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-249-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2018-11-01_Attachment O
Revisions for ADIT and AFDUC to be effective 1/1/2019.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5074.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-250-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA SA No.
4919; Queue No. AC2-073 to be effective 1/30/2018.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5082.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-251-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: ISO New England and New
England Power Pool; Update to Schedule 16 of the OATT to be effective
1/1/2019.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5091.
    Comments Due: 5 p.m. ET 11/23/18/

    Docket Numbers: ER19-252-000.
    Applicants: Florida Power & Light Company.
    Description: Sec.  205(d) Rate Filing: FPL and Seminole Revised &
Restated NITSA No. 162 to be effective 1/1/2019.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5097.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-253-000.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 205: Agreement No. 2437--CRA
between NMPC and MAIT to be effective 10/2/2018.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5104.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-254-000.
    Applicants: Grant County Interconnect, LLC.
    Description: Initial rate filing: Filing of Coordination Services
Agreement for Grant Plains Wind to be effective 11/2/2018.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5108.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-255-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA SA No.
5094; Queue No. AD1-048 to be effective 5/14/2018.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5113.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-257-000.
    Applicants: Interstate Power and Light Company.
    Description: Sec.  205(d) Rate Filing: Interstate Power and Light
Company Wholesale Formula Rate Application to be effective 12/31/2018.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5118.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-258-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to Update
References to Interregional Agreements to be effective 1/1/2019.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5120.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-259-000.
    Applicants: Northern States Power Company, a Minnesota corporation.
    Description: Sec.  205(d) Rate Filing: 2018-11-01 MKPC Maple Riv
Fac Const-648-0.0.0-Filing to be effective 1/1/2019.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5125.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-260-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Sec.  205(d) Rate Filing: DEF Revisions to Joint OATT
Schedule 2 to be effective 1/1/2019.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5129.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-261-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to Modify Market
Participation Provisions for Jointly Owned Units to be effective 7/1/
2019.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5143.
    Comments Due: 5 p.m. ET 11/23/18.

    Docket Numbers: ER19-262-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 767 6th Rev--NITSA with
Basin Electric Power Cooperative, Inc. to be effective 1/1/2019.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5149.
    Comments Due: 5 p.m. ET 11/23/18.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH19-2-000.
    Applicants: UGI Corporation.
    Description: UGI Corporation submits FERC 65-B Notice of Change in
Facts of Waiver Notification.
    Filed Date: 10/31/18.
    Accession Number: 20181031-5301.
    Comments Due: 5 p.m. ET 11/21/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 1, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-24328 Filed 11-6-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 190 (Wednesday, October 1, 2014)]
[Proposed Rules]
[Pages 59182-59186]
[FR Doc No: 2014-23354]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2001-0002; FRL-9917-27-Region-2]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Consolidated Iron and Metal
Superfund Site

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule; notice of intent.

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

SUMMARY: The Environmental Protection Agency (EPA), Region 2, is
issuing a Notice of Intent to Delete the Consolidated Iron and Metal
Superfund Site (Site), located in the City of Newburgh, Orange County,
New York, from the National Priorities List (NPL) and requests public
comments on this proposed action. The NPL, promulgated pursuant to
section 105 of 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 State of New York, through the New York State
Department of Environmental Conservation (NYSDEC), have determined that
all appropriate response actions under CERCLA, other than operation,
maintenance, and five-year reviews, have been completed. However, this
deletion does not preclude future actions under Superfund.

DATES: Comments must be received by October 31, 2014.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-2001-0002, by one of the following methods:
     Web site: http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Mail: To the attention of Michael Negrelli, Remedial
Project Manager, U.S. Environmental Protection Agency, Region 2,
Emergency and Remedial Response Division, 290 Broadway, 20th Floor, New
York, NY 10007-1866.
     Hand Delivery: Superfund Records Center, 290 Broadway,
18th Floor, New York, NY 10007-1866 (telephone:<PHONE_NUMBER>). Such
deliveries are only accepted during the Record Center's normal hours of
operation (Monday to Friday from 9:00 a.m. to 5:00 p.m.). Special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
2001-0002. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://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 http://www.regulations.gov or email. The http://www.regulations.gov Web site
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 http://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 comments and with any
disk or CD-ROM that you submit. If EPA cannot read your comments due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comments. Electronic files should
avoid the use of special characters and any form of encryption and
should be free of any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at:

U.S. Environmental Protection Agency, Region 2, Superfund Records
Center, 290 Broadway, 18th Floor, New York, NY 10007-1866, Phone: 212-
637-4308, Hours: Monday to Friday from 9:00 a.m. to 5:00 p.m.
and

Newburgh Free Library, Consolidated Iron and Metal Site Repository
File, 124 Grand Street, Newburgh, NY 12550, Phone:<PHONE_NUMBER>, Hours:
Monday & Thursday from 9:00 a.m. to 9:00 p.m., Tuesday, Wednesday, &
Friday from 9:00 a.m. to 5:00 p.m., Saturday from 10:00 a.m. to 3:00
p.m.

FOR FURTHER INFORMATION CONTACT: Michael Negrelli, Remedial Project
Manager, U.S. Environmental Protection Agency, Region 2, Emergency and
Remedial Response Division, 290 Broadway, 20th floor, New York, NY
10007-1866;<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

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

I. Introduction

    EPA Region 2 is announcing its intent to delete the Consolidated
Iron and Metal Superfund Site from the NPL and requests public comment
on this proposed action. The NPL constitutes Appendix B of 40 CFR part
300, which

is the NCP, which EPA promulgated pursuant to Section 105 of CERCLA, as
amended. EPA maintains the NPL as the list of 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). As described in
40 CFR 300.425(e)(3) of the NCP, sites deleted from the NPL remain
eligible for Fund-financed remedial actions if future conditions
warrant such actions.
    EPA will accept comments on the proposal to 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 discusses procedures that EPA is using
for this action. Section IV discusses the Consolidated Iron and Metal
Superfund Site and demonstrates how it meets the deletion criteria.

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 parties have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed responses under CERCLA have been
implemented, and no further action by responsible parties is
appropriate; or
    iii. The remedial investigation has shown that the release of
hazardous substances poses no significant threat to public health or
the environment and, therefore, 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 deletion of the Site.
    (1) EPA consulted with the State before developing this Notice of
Intent to Delete.
    (2) EPA has provided the State 30 working days for review of this
notice 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 of New York, through the NYSDEC, has concurred with
deletion of the Site from the NPL.
    (5) Concurrently with the publication of this Notice of Intent to
Delete in the Federal Register, a notice is being published in a major
local newspaper, The Times Herald Record. The newspaper notice
announces the 30-day public comment period concerning the Notice of
Intent to Delete the Site from the NPL.
    (6) The EPA placed copies of documents supporting the proposed
deletion in the deletion docket and made these items available for
public inspection and copying at the Site information repositories
identified above.
    If comments are received within the 30-day public comment period on
this document, EPA will evaluate and respond appropriately to the
comments before making a final decision to delete. 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 delete the Site, the Regional Administrator
will publish a final Notice of 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 in the
Site information repositories listed above.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion 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 Site Deletion

    The following summary provides EPA's rationale for deleting the
Site from the NPL.

Site Background and History

    The Consolidated Iron and Metal Site is an inactive car and scrap
metal junk yard located at the foot of Washington Street in the City of
Newburgh, Orange County, New York. The facility operated from the 1950s
until 1999. The Site occupies about eight acres of land bordering the
Hudson River in a mixed industrial, commercial, and residential area.
    Scrap metal processing and storage operations took place at the
Site during its period of operation. Various types of scrap metal were
received, including whole automobiles, automobile engines,
transmissions, batteries, keypunch machines, computer parts, white
goods (appliances), and transformers. A smelter was used primarily to
melt aluminum transmissions to produce a reusable aluminum product.
Other materials were also smelted, resulting in a lead-contaminated
ash/slag by-product. Other operations included sorting ferrous and non-
ferrous scrap metal for recycling, baling and shearing large pieces of
metal, including whole cars, into smaller pieces for transport, and
flattening of cars. From 1997 to 1999, the NYSDEC conducted several
inspections at the facility and cited the owner for a number of
violations. Subsequent inspections by NYSDEC noted that the owner had
failed to adequately correct the violations and in the fall of 1999,
the New York State Attorney General shut down operations at the Site
for various violations, including illegal discharges to surface water
without a permit.
    In August 1998, EPA sampled an ash/slag pile at the Site that was
generated by the aluminum smelting operation and found it to be
contaminated with lead and polychlorinated biphenyls (PCBs). The scrap
metal in the pile was segregated out and the resulting fines pile,
estimated at 6,600 tons, was removed from the Site in 1999 and placed
in an approved treatment, storage, and disposal facility (TSDF) for
stabilization and landfilling. Also in 1999, EPA sampled other
processed soil piles at the Site which were also found to be
contaminated with lead and PCBs; these soil piles were similarly
transferred to an approved TSDF. Additionally in 1999, EPA constructed
a berm from Site soils to prevent storm water from carrying Site
contaminants into the Hudson River.
    In September 1999, EPA conducted a preliminary study at the Site to
determine the horizontal and vertical extent of contamination. Surface
and subsurface soil and groundwater samples were collected and
analyzed,

indicating the presence of volatile organic compounds (VOCs),
semivolatile organic compounds (SVOCs), pesticides, PCBs, and metals at
concentrations greater than background in the surface and subsurface
soils. Further, PCBs and metals were detected in Hudson River
sediments, which is a fishery and ecologically sensitive environment.
Accordingly, the Site was proposed to the NPL on December 1, 2000 (65
FR 75215) and placed on the NPL on June 14, 2001 (66 FR 32235).

Remedial Investigation and Feasibility Study

    In 2002, EPA developed a work plan for the performance of a
remedial investigation and feasibility study (RI/FS) to more thoroughly
determine the extent of contamination at the Site and to devise
alternatives to mitigate the contamination. Prior to conducting the RI,
it was necessary to clear the Site of the debris and some of the
structures located on-Site. Accordingly, from June to September 2003,
EPA conducted Site clearing operations which included the removal of
tires, scrap metal, concrete, lead-impacted soil, and hydraulic oil
from the Site and the demolition and clearing of the office building
and three process-area buildings. The RI was initiated in June 2004 and
followed by a FS in 2005 to evaluate potential alternatives to address
the widespread soil contamination at the Site. A preferred alternative
was presented to the public for review and comment in July 2006.
Results or the RI and FS were summarized in the Record of Decision
(ROD) issued by EPA in 2006.

Selected Remedy

    The Site remedy was selected and memorialized in the Site ROD which
was issued on October 4, 2006. The elements of the selected remedy were
as follows:
     A remedial design (RD) program to provide the details
necessary for the construction and monitoring of the remedial program;
     Removal and off-Site disposal of surface debris and
demolition, removal, and off-Site disposal of the foundations/basements
of the former process area buildings and of the former garage in its
entirety;
     Excavation and off-Site disposal of contaminated soil
exceeding the residential preliminary remediation goal (PRG) for lead
(400 parts per million (ppm)) down to six feet below ground surface
(bgs);
     Excavation and off-Site disposal of contaminated soil
exceeding the PRG for VOCs and PCBs in subsurface soils (10 ppm total
for each) to the water table;
     Placement of a readily-visible demarcation material at the
interface between the excavations and backfill;
     Backfilling the excavated soil with clean fill, meeting
the PRG values, to grade;
     Imposition of institutional controls in the form of an
environmental easement and/or restrictive covenant that will at a
minimum require: (a) Restricting any excavation below the soil cover's
demarcation layer of six feet unless the excavation activities are in
compliance with an EPA-approved site management plan (SMP); (b)
restricting new construction at the Site unless an evaluation of the
potential for vapor intrusion is conducted and mitigation, if
necessary, is performed in compliance with an EPA-approved SMP; and (c)
restricting the use of groundwater as a source of potable or process
water unless groundwater quality standards are met;
     Development of a SMP that provides for the proper
management of all Site remedy components post-construction, such as
institutional controls, and that shall also include: (a) Monitoring of
Site groundwater to ensure that, following the soil excavation, the
contamination is attenuating and groundwater quality continues to
improve; (b) an inventory of any use restrictions on the Site; (c)
necessary provisions for ensuring the easement/covenant remains in
place and is effective; (d) provision for any operation and maintenance
required of the components of the remedy, and (e) the requirement that
the owner or person implementing the remedy submit periodic
certifications that the institutional and engineering controls are in
place; and
     Periodic reviews by EPA to ensure that the remedy
continues to be protective of public health and the environment.

Response Actions

    In early 2007, EPA provided notice to the potentially responsible
parties (PRPs) identified for the Site, offering them the opportunity
to undertake the work. Negotiations concluded in 2008 with a Consent
Decree cashout settlement entered into by certain of the PRPs and EPA,
with EPA performing the work with a combination of PRP and federal
funding. Under this Consent Decree, the City of Newburgh, as Site
owner, also agreed to develop the SMP and the environmental easement/
restrictive covenant placed on the Site. The Consent Decree was entered
by the Court in February 2009.
    In spring 2008, EPA conducted a topographic survey, geophysical
survey, geoprobe sampling program, and test pit excavations to develop
a design document for the remedial construction. The RD report was
completed in October 2009.
    From September through November 2008, EPA conducted certain
preparatory activities at the Site to facilitate the remedial
construction. These activities included the demolition and removal of
the garage, the demolition and removal of the remaining building
foundations, the removal of scrap metal and debris, and the dismantling
and removal of a truck frame and metal barges from the shoreline of the
Site. The former building foundation areas were backfilled with clean
material and the truck frame and barge areas of the Site were replaced
with boulders to restore the shoreline. The contaminated soil
associated with the building foundation removal was sampled for
disposal purposes and shipped to an appropriate facility in December
2008.
    Following the preparatory activities, construction of the remedial
action commenced on July 6, 2009. The work was done by EPA under the
Emergency Rapid Response Services contract; the prime contractor was
WRS Infrastructure & Environment Inc. The work was divided into two
phases: Phase One involved the excavation and off-Site disposal of
60,000 tons of Site soils across the southern half of the Site to a
depth of approximately six feet and backfilling with clean fill. Phase
Two involved the excavation and off-Site disposal of approximately
30,000 tons of PCB and VOC impacted soils to the water table and the
excavation and off-Site disposal of remaining Site soils, approximately
27,000 tons, covering the northern third of the Site to a depth of six
feet (or deeper in the areas where site processes were conducted) and
backfilling with clean fill. Phase One was completed in October 2009
and Phase Two was completed in August 2010.
    Soil excavation and transport was carried out using clean-diesel
equipment in accordance with the Region 2 Clean and Green policy.
Excavated soil was transported under Phase One to a nearby rail depot
in Newburgh, while excavated soil was transported under Phase Two to a
rail depot in Middletown, New York. Soil was tested before leaving the
Site to ensure its disposal in an appropriate facility. Trucks and
railcars were lined and sealed to prevent spillage of material during
transport and transfer.
    Backfilling was performed concurrently with the excavation,
maintaining an adequate buffer zone to

avoid cross contamination. Backfill material was tested for suitability
before placement, meeting the guidelines set by NYSDEC for restricted
residential use and the PRG values required by the ROD to be met for
backfill. Prior to placement of the backfill, the base of the
excavation was sampled on a 50-foot grid to characterize and document
the soil remaining on Site; samples were analyzed for VOCs, SVOCs,
PCBs, and metals. Geotextile fabric was then placed to demarcate the
interface between potentially contaminated soil and clean backfill
material. For approximately 80% of the Site, select structural fill
suitable for redevelopment of the Site was placed in one-foot lifts and
compacted to specification using a vibratory roller, and graded to
design specification. The remaining 20% of the Site, essentially a 100-
foot buffer along the river edge, required additional allowances for
subsurface drainage and the backfill consisted of select structural
fill, clean stone, geotextile, and silty loam or bank run. The eastern
Site boundary adjacent to the Hudson River was graded to match the
grade of the backfilled material and the bank fortified with rip rap
along the entire river front. To allow for drainage along the north end
of the Site, a shallow surface swale was constructed just inside the
north fence line using the backfilled material. Following reaching
final grade with backfill soil, the entire Site was covered with a
minimum of six inches of topsoil and hydroseeded to provide a
vegetative cover to ensure dust and erosion control.
    Excavation, transport and backfilling were conducted from July 2009
through August 2010. Surveying was performed during the entire
operation by a New York State licensed surveyor for documentation
purposes and to ensure that lift layer depths were accurate. Dust
suppression and air monitoring were routinely performed in accordance
with design specifications.
    In addition to the work performed on the Site, at the request of
the New York State Department of Health (NYSDOH), EPA removed soils
just beyond the north and south property boundaries to a depth of
approximately two feet (where not hindered by utilities) and backfilled
with clean fill. This was done to ensure that any contaminated soil
that may have migrated beyond the Site property was also mitigated.
    EPA conducted a pre-final inspection with NYSDEC at the Site on
June 9, 2010, and a punch list was compiled. A final inspection of the
Ste conducted on August 18, 2010 confirmed that all of the punch list
items were determined to be completed. EPA completed its Remedial
Action Report (RAR) for the Site on March 16, 2012. The RAR documented
all the remedial activities conducted at the Site and included as-built
drawings to document Site conditions at completion. The City of
Newburgh, as current property owner, is responsible for management of
the Site in accordance with the SMP developed for post-remediation uses
of the Site. Site management responsibilities will be transferred to
any future Site owner.
    The ROD called for the following with respect to institutional
controls: imposition of institutional controls in the form of an
environmental easement and/or restrictive covenant that will at a
minimum require: (a) Restricting any excavation below the soil cover's
demarcation layer of generally six feet (deeper in some areas of the
Site and shallower in others) unless the excavation activities are in
compliance with an EPA-approved SMP; (b) restricting new construction
at the Site unless an evaluation of the potential for vapor intrusion
is conducted and mitigation, if necessary, is performed in compliance
with an EPA-approved SMP; and (c) restricting the use of groundwater as
a source of potable or process water unless groundwater quality
standards are met. The restrictions are memorialized in an
environmental easement filed with the Orange County Clerk on September
11, 2012. The environmental easement is filed on the eight acre parcel
comprising the Site, identified in municipal records as Section 40,
Block 3, Lot 3.

Cleanup Levels

    Data are collected and reviewed to ensure that remedial action
objectives (RAOs) are met following implementation of the remedial
action. For this Site, RAOs were only established for soil. The RAOs
for soil are: (1) Prevent or minimize exposure to human and ecological
receptors through ingestion and inhalation of or dermal contact with
contaminated soils; and (2) minimize or eliminate contaminant migration
from Site soils to groundwater and surface water. These RAOs and the
associated cleanup levels set forth in the ROD were met upon completion
of the remedial construction, documented in the RAR for the Site dated
March 16, 2012.
    Due to the limited risks and exposure to the groundwater at this
Site, institutional controls are deemed adequate to address any
potential future exposure. Specifically, deed restrictions have been
imposed to prevent the use of groundwater as a source of potable or
process water unless groundwater quality standards are met. Long-term
monitoring will be conducted to ensure that the selected Site remedy is
protective of human health and the environment. The groundwater will be
monitored as part of the post-construction response action to ensure
that the contamination is attenuating and groundwater quality continues
to improve.
    In May 2013, groundwater samples were collected from the ten
monitoring wells (MWs) re-developed at the Site following construction.
Samples were analyzed for VOCs, SVOCs, PCBs, and inorganics.
    VOCs were detected above screening criteria in two samples.
Benzene, toluene, ethylbenzene, and m,p-xylene exceeded screening
criteria in the sample collected from MW-1, with values of 22
micrograms per liter (ug/L), 9.9 ug/L, 720 ug/L, and 73 ug/L
respectively. The sample collected from upgradient monitoring well MW-9
contained benzene at 5 ug/L.
    The inorganic elements iron, magnesium, manganese, sodium, and zinc
exceeded the screening criteria in most wells. However, these metals
occur in high concentrations naturally in New York State and the trend
in the levels measured in 2013 compared to levels measured in 2004
indicates decreasing concentrations. In addition, these screening
criteria are secondary maximum contaminant levels (MCLs) established by
the Safe Drinking Water Act. They will continue to be monitored. The
contaminant of concern, lead, was detected above the screening
criterion in a single sample collected from MW-6, at 70 ug/L.
    Groundwater data review indicates that the low levels of
contamination in Site groundwater are attenuating and groundwater
quality has improved compared to baseline levels measured prior to
remedial activities. The main contaminants of concern identified in the
ROD were benzene and lead. In the 2013 sampling event, benzene was
detected in both the background well and one on-Site well. Lead was
detected in only one well above federal drinking water standards. These
data support the ROD assumption that the groundwater contamination is
localized and the decrease in frequency indicates that limited residual
groundwater contamination has attenuated. The environmental easement
placed on the Site property restricts the use of groundwater as a
source of potable or process water unless groundwater quality standards
are met. Groundwater quality will continue to be monitored in
accordance with the SMP.

Operation and Maintenance

    The ROD called for the development of an SMP to provide for the
proper management of all post-construction remedy components. The SMP
was approved in June 2014.
    The SMP includes operation and maintenance (O&M) activities
required for the Site. Because there are no mechanical systems
installed at the Site, O&M activities consist of periodic inspections
of the Site property (minimally once per year and additionally
following severe weather events) to note general Site conditions and to
ensure that the security fence and monitoring wells are in good repair.
Groundwater sampling of the ten on-Site monitoring wells is conducted
in accordance with the schedule established in the SMP to verify that
the low levels of contamination in Site groundwater are attenuating and
that groundwater quality improves as a result of the Site remediation.
    In addition to media monitoring, O&M activities include periodic
certification that the institutional controls established in the
environmental easement attached to the Site property are unchanged and
that nothing has occurred that would impair the ability to protect
public health and the environment or otherwise constitute a violation
or failure to comply with Site controls. This certification is provided
in the Periodic Review Report, to be submitted annually by the Site
owner.

Five-Year Review

    Hazardous substances remain at this Site above levels that would
allow for unlimited use and unrestricted exposure. Therefore, pursuant
to CERCLA Section 121(c), EPA is required to conduct a review of the
remedy at least once every five years. The first five-year review was
completed on July 16, 2014. No issues, recommendations or follow-up
actions have been identified during the five-year review. The five-year
review concluded that the implemented remedy for the Site is protective
of human health and the environment.

Community Involvement

    Public participation activities for this Site have been satisfied
as required in CERCLA Sections 113(k) and 117, 42 U.S.C. 9613(k) and
9617. As part of the remedy selection process, the public was invited
to comment on the proposed remedy. All other documents and information
that EPA relied on or considered in recommending this deletion are
available for the public to review at the information repositories
identified above.

Determination That the Site Meets the Criteria for Deletion From the
NCP

    All of the completion requirements for this Site have been met, as
described in the June 30, 2014 Final Close-Out Report. The State of New
York, in a May 30, 2014 letter, concurred with the proposed deletion of
this Site from the NPL. As described in this Notice of Intent to
Delete, the implemented remedy achieves the degree of cleanup specified
in the ROD for all exposure pathways; the selected RAOs for the Site
and associated cleanup levels are consistent with agency policy and
guidance; and no further Superfund response is needed to protect human
health and the environment.
    The NCP specifies that EPA may delete a site from the NPL if all
appropriate Fund-financed response under CERCLA has been implemented,
and no further response action by responsible parties is appropriate
[40 CFR 300.425(e)]. EPA, with the concurrence of the State of New
York, believes that this criterion for deletion has been met.
Consequently, EPA is intending to delete this Site from the NPL.
Documents supporting this action are available for review at the
information repositories identified above.

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. 1321(c)(2); 42 U.S.C. 9601-9657; 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: September 19, 2014.
Judith A. Enck,
Regional Administrator, EPA, Region 2.
[FR Doc. 2014-23354 Filed 9-30-14; 8:45 am]
BILLING CODE 6560-50-P