AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

September 14 - 17, 2010

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2010-0481

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Reevaluation of the Human Health Effects of Atrazine: Review of
Non-cancer Effects and Drinking Water Monitoring Frequency

Please note that all times are approximate (see note at end of Agenda).

Day 1

Tuesday, September 14, 2010

8:30 a.m.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:35 a.m. 	Introduction and Identification of Panel Members –

	Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Session
Chair

8:40 a.m.	Welcome and Opening Remarks – Steven Bradbury, Ph.D., Acting
Director, Office of Pesticide Programs, EPA

8:50 a.m.	Welcome and Introductions – Tina Levine, Ph.D., Director,
Health Effects Division, Office of Pesticide Programs, EPA

9:00 a.m.	Atrazine Re-evaluation:  Introduction and Status – Anna
Lowit, Ph.D., Health Effects Division, Office of Pesticide Programs, EPA

9:30 a.m.	Evaluation of Atrazine Non-Cancer Epidemiology Literature -

	Carol Christensen, Ph.D., M.P.H., Health Effects Division, Office of
Pesticide Programs, EPA

10:30 a.m.	Break

10:45 a.m.	Atrazine: Proposed Updates to the Dose-Response Assessment -
Chester Rodriguez, Ph.D., Health Effects Division, Office of Pesticide
Programs, EPA

12:00 p.m.	Lunch

1:15 p.m.	Approaches to Evaluating Water Sampling Strategies and
Frequency of Monitoring - Nelson Thurman, M.S. and Mary Frankenberry,
Environmental Fate and Effects Division, Office of Pesticide Programs,
EPA

2:15 p.m.	Scientific Considerations in Potential Sensitivity of Infants
and Children and Implications of MOA on Water Monitoring Strategy -

	Anna Lowit, Ph.D., Health Effects Division, Office of Pesticide
Programs, EPA

3:15 p.m.	Break

3:30 p.m.	Atrazine Re-evaluation: Summary and Next Steps -

	Anna Lowit, Ph.D., Health Effects Division, Office of Pesticide
Programs, EPA

5:00 p.m.	Adjourn

Day 2

Wednesday, September 15, 2010

8:30 a.m.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:35 a.m. 	Introduction and Identification of Panel Members –

	Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Session
Chair

8:45 a.m.	Follow-up from Previous Day’s Presentations

9:15 a.m.	NIEHS Presentation - Suzanne Fenton, Ph.D., Cellular and
Molecular Pathology Branch, National Institute of Environmental Health
Sciences

10:00 a.m.	Break

10:15 a.m.	Public Comment

12:30 p.m.	Lunch

1:30 p.m.	Public Comment

3:30 p.m.	Break

3:45 p.m.	Charge To Panel - Question 1.0 - Non-cancer Epidemiology

Section 3.0 and Appendix B of the draft Issue Paper provide the Agency
reviews and synthesis of the non-cancer epidemiology studies available
for atrazine. These include studies on a variety of topics, notably
female and male reproductive outcomes and birth outcomes in addition to
other topics.   Section 4.0 integrates the findings of the epidemiology
and experimental toxicology studies.

Question 1.1

Please comment on the sufficiency of the Agency’s non-cancer
epidemiology reviews with respect to identifying the major strengths and
limitations of each study.

4:30 p.m.	Charge To Panel

Question 1.2

At this time, atrazine’s non-cancer epidemiologic database is not
robust enough for inclusion in quantitative risk assessment and does not
support the ability to determine causal associations. There are several
limitations present in the current database, and the quality of atrazine
exposure assessment is paramount among the limitations.  In Section 4.0
of the draft Issue Paper, the Agency describes the qualitative
similarities and differences between the epidemiologic findings and the
experimental toxicology database.  In short, the observational studies
– particularly those related to reproductive effects in adult females,
as well as small for gestational age in newborns – lend further
support for the human relevance of the laboratory animal findings.

a.  	Please comment on the scientific information that does and does not
support the Agency’s conclusions (as described in Section 3.0) with
respect to the characterization of quality, and limitations of the
non-cancer epidemiologic database and its utility in hazard
characterization, dose response analysis, and quantitative risk
assessment.

5:00 p.m.	Charge to Panel

b.	Please comment on scientific information that does and does not
support the integrative analysis and conclusions, contained in Section
4.0, with respect to the similarities, differences, and uncertainties of
the experimental toxicology and epidemiologic findings.

5:30 p.m.	Meeting Adjourns

Day 3

Thursday, September 16, 2010

8:30 a.m.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:35 a.m. 	Introduction and Identification of Panel Members –

	Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Session
Chair

8:45 a.m.	Charge to Panel - Question 2.0 - Review of Studies on Mammary
Gland Development

At the April SAP, the Agency evaluated effects of atrazine on a number
of apical endpoints including neuroendocrine, neurotoxicity, and
immunotoxicity effects.  At that time, the Agency deferred review of
experimental toxicology studies on mammary gland development to the
September SAP meeting.  Development of mammary tissue occurs in defined
stages linked to sexual maturation and reproduction including embryonic,
pre- and peripubertal periods, as well as pregnancy and lactation.
Given that atrazine affects the hormonal environment and reproductive
system, it is not unreasonable to hypothesize that it may also affect
mammary gland development.  The database of mammary gland development
studies includes four studies---three from same the research group
(Rayner et al., 2004; Rayner et al., 2005; Enoch et al., 2007) in
addition to one conducted by Coder (2010).  It is important to note that
the key events leading to reported delays in mammary gland development
in the young following gestational exposure to atrazine are not known
and none of these studies propose a mechanism/mode of action.

Question 2.1

The studies from the two different research groups yielded different
results regarding the impact of atrazine on mammary gland development.
While the Rayner and Enoch studies report delays in mammary gland
development, the Coder study does not.  The basis of these different
findings is unknown.  However, one notable difference in the study
design used by the two research groups is the scoring system.  The
Rayner et al. and Enoch et al. studies used a subjective scoring scale
with a 1-4 scoring system (1 = poor development/structure; 4 = normal
development/structure) with criteria which vary depending on the age of
the pups. In contrast, Coder employed a quantitative morphometric
analysis to evaluate mammary gland development.  In addition, the Coder
study also included the use of BrDU labeling to assess cell
proliferation in the mammary tissue.

Please comment on the quality, strengths, and limitations of the mammary
gland development studies by Rayner et al. (2004, 2005) and Coder (2010)
studies.  Please discuss in your comments factors which could lead to
different findings.  Please comment on the Agency’s conclusions
regarding these studies on atrazine.

9:30 a.m.	Charge to Panel

Question 2.2.

In three of the studies considered in Question 2.1 (Rayner et al., 2004
and 2005; Coder, 2010), effects have only been observed at an atrazine
dose of 100 mg/kg/day.   In contrast, Enoch et al. (2007) report delays
in mammary gland development as low as 0.09 mg/kg/day following exposure
to atrazine and a mixture of several metabolites/degradates (DEA, DIA,
DACT, hydroxy-atrazine).   The Agency’s review of this mixture study
is provided in Appendix A (Section A.10)    Please comment on the Enoch
et al. (2007) study and the degree to which the Agency’s review
accurately reflects the strengths and limitations of the study.  Please
include in your comments a consideration of the study design of the
mixtures experiment and how this design impacts the interpretation of
the results.

10:15 a.m.	Break

10:30 a.m.	Charge to Panel

Question 2.3.

As described in the Introduction of the draft Issue Paper (Section 1.0),
the Agency’s problem formulation is being conducted in a step-wise
manner.  One important component of this problem formulation is the
evaluation of the overall database and the quality of the available
experimental toxicology studies.  In the case of mammary gland
development, the Agency is proposing to acknowledge these four studies
(Rayner et al., 2004; Rayner et al., 2005; Enoch et al., 2007; Coder,
2010) in the hazard characterization but place little emphasis on them
in its proposed updates to the dose-response assessment for atrazine.
The only findings reported in the Rayner et al., (2004), Rayner et al.,
(2005), and Coder (2010) studies, occurred at a high dose (100
mg/kg/day) which is approximately 50-fold higher than the PoD of 1.86
for LH attenuation being proposed by the Agency.  In the Enoch et al.
(2007) study, there are significant limitations with the conduct and
reporting the Agency believes which preclude the study from use in
quantitative risk assessment.

In light of Panel discussion on Questions 2.1 and 2.2, please comment on
the manner in which the Agency has proposed to use the mammary gland
development studies in the hazard assessment for atrazine.

11:15 a.m.	Charge to Panel - Question 3.0:  Proposed Updates to the
Dose-			Response Assessment

At the April, 2010 SAP, the Panel made two key recommendations related
to dose-response assessment:  1) consider pursuing a dose-response
analysis based on an internal dose metric, as an alternative to the
administered dose metric used in the previous risk assessment; and 2)
identify the sensitive endpoint associated with functional impairment
and perform benchmark dose (BMD) modeling.  The Agency conducted both
recommended analyses (Section 5.0 of the draft Issue Paper) in response
to these recommendations.  LH attenuation, as a key event in
atrazine’s MoA, is the most sensitive internal dose metric that is
associated with a number of endocrinopathies

Question 3.1

Given that there is no robust pharmacokinetic model yet available, a
non-

compartmental analysis of the existing pharmacokinetic data was
conducted and described in Section 5.2 of the draft Issue Paper.  EPA
thinks this represents the best method to estimate an internal dose
metric without exceeding the limits of the available data.

a.   Please comment on the Agency’s analysis of the pharmacokinetic
data contained in Thede (1987) to estimate internal dose reflective of
atrazine and its metabolites in rat plasma.

11:45 a.m. 	Charge to Panel

b.   Based on Figure 5.5 in the draft Issue Paper, the Agency has
preliminarily concluded that plasma levels of atrazine and its
metabolites reach (or nearly reach) pharmacokinetic pseudo-steady state
in the rat plasma after approximately four daily oral exposures over a
wide range of doses.   Please comment on the extent to which the data do
and do not support this finding.

12:15 p.m.	Lunch

1:15 p.m.	Charge to Panel

c.   Figure 5.8 of the draft Issue Paper shows a plot of LH attenuation
data versus administered atrazine across a range of exposure durations
(i.e., four days up to six months).  The data contained on this figure
were collected from several different laboratories and involved two
modes of oral administration (dietary, oral gavage) and two different
rat strains.  Attenuation of LH, as measured by percent of control, is
remarkably similar across studies, strains, laboratories, and most
notably duration of exposure.  The Agency has preliminarily concluded
that the findings on Figure 5.8 strongly support the hypothesis that
pseudo-steady state is achieved (or nearly achieved) in adult rats after
four daily consecutive oral exposures.  The Agency also believes that
pseudo-steady state is strongly associated with the attenuation of the
LH surge following atrazine exposure in rats. Please comment on the
analysis shown in Figure 5.8 and the Agency’s preliminary conclusions
related to these findings in rats.

2:00 p.m.	Charge to Panel

Question 3.2

In Section 5.3, the Agency describes a benchmark (BMD) analysis
conducted for LH attenuation studies.  As described in the draft Issue
Paper, the Agency initially considered a wide range of toxicological
endpoints for inclusion in the BMD analysis.  In considering all of the
data, this analysis focused on studies measuring LH attenuation where
female rats were exposed orally for four days and/or longer. This was
not only the most sensitive endpoint but it’s temporal and dose
response are well defined experimentally. The LH effect originates from
atrazine’s effect on the hypothalamic control of pituitary function
through its interference with GnRH neurotransmitters.  Thus, protection
from LH attenuation as a precursor event to several functional
impairments would be protective of atrazine’s neuroendocrine effects.

a.   Please comment on the BMD analysis summarized in Section 5.3 of the
draft Issue Paper with details provided in Appendix C.

2:45 p.m.	Charge to Panel

b   The selection of a suitable benchmark response (BMR) is an important
component of conducting a BMD analysis.  As described in Section 5.3,
for continuous endpoints, like LH attenuation, the BMR most often
represents an X% change from background levels (or untreated controls).
 Typically, the BMR is selected on the basis of a combination of
biological (mode of action, quantitative link between key events and
adverse outcomes, historical/concurrent controls) and statistical
considerations (sample size, variability, etc). LH attenuation may be
potentially associated with several adverse outcomes and the level of
attenuation of the LH surge considered to be adverse is a function of
several factors including the functional outcome and the life-stage.
There is an absence of information concerning the level of response (or
% change) associated with the various functional impairments.  Also, the
differences in reproductive cycles/aging between rodents and humans add
an additional level of complexity to establishing a specific BMR value.
When an X% change can not be defined, the Agency’s draft BMD

guidance suggests that the BMD and BMDL corresponding to a change in the
mean response equal to one standard deviation from the control mean be
used as the BMR.  This approach was applied to atrazine.  Please comment
on the scientific factors important for establishing a BMR for LH
attenuation as part of the BMD analysis for atrazine.

3:30 p.m.	Break

3:45 p.m.	Charge to Panel - Question 4.0: Approaches To Evaluating Water
			Sampling Strategies And Frequency Of Monitoring

The ultimate utility of pesticide monitoring data for drinking water
exposure estimations in human health risk assessments depends on how
well the monitoring data characterize the spatial and temporal
variability of pesticide concentrations in drinking water, with an
emphasis on the upper end of the exposure distribution.  In addition,
the method used to estimate concentrations from monitoring data depends
on the duration of concern and how critical it is to estimate peak
concentrations.

Question 4.1

A well-designed drinking water monitoring study takes into account both
spatial and temporal patterns of exposure. Please comment on the
USEPA’s recommended framework for designing a monitoring study by
targeting the most vulnerable areas, targeting seasonal times for more
intensive sampling, basing sampling frequency on the toxicological
exposure duration of concern, and using autosamplers to supplement
monitoring data (see Section 7.2 of the draft Issue Paper).

4:15 p.m.	Charge to Panel

Question 4.2

The April 2010 SAP recommended that simulations of candidate monitoring
strategies and evaluations of the utility of different exposure
estimation methods be benchmarked against intensive empirical data that
cover a representative range of sites.  In response, the USEPA proposes
using more intensively sampled ambient water monitoring for flowing
waters and PRZM/EXAMS modeling for static water bodies, matching them to
the CWS based on similar chemograph shapes (see Section 7.3).

a.   Please comment on the Agency’s proposal to use chemograph shapes
(number, duration, and magnitude of peaks) to match CWS with more
intensively monitored datasets.  In particular, the Agency is interested
in recommendations on approaches for matching chemograph shapes given
the loss of short-duration peaks that occurs with less frequent
sampling.

4:45 p.m	Charge to Panel

b.   Please comment on the strengths and weaknesses of using more
intensively sampled datasets from Heidelberg and AEEMP for analysis of
flowing water and PRZM/EXAMS for lakes and reservoirs.

5:15 p.m.	Meeting Adjourns

Day 4

Friday, September 17, 2010

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members –

	Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Session
Chair

8:45 A.M.	Charge to Panel

Question 4.3

Once the magnitude and duration of exposure of toxicological concern are
identified, the USEPA will determine which method(s) to use to analyze
the existing atrazine CWS monitoring data for use in drinking water
exposure estimates.  Based on the April 2010 SAP recommendations, the
Agency is focusing on regression-based modeling combined with random
function modeling (for example, a revised WARP model coupled with
kriging or the USGS SEAWAVE-Q model).

Please comment on the strengths and weaknesses of these proposed
approaches and provide any recommendations for improving the model
applications.

9:30 a.m.	Charge to Panel

Question 5.0:  Scientific Considerations in Potential Sensitivity of
Infants & Children

As described in Section 6.0 in the draft Issue Paper, the FFDCA, as
amended by the FQPA (1996), requires the Agency to give special
attention to infants and children by placing emphasis on the
availability of toxicology and exposure information to estimate the
potential risk to these age groups.  The 2003 Registration Eligibility
Decision (RED) notes that the Agency reduced the FQPA Safety Factor for
those localities which are part of the drinking water monitoring program
conducted by Syngenta, as required by EPA.  This reduction in the Safety
Factor was based on more intensive monitoring required in the monitoring
program that reduced the uncertainty for estimating concentrations of
atrazine and its metabolites in drinking water for the 90-day rolling
average identified in the previous risk assessment as the appropriate
duration of concern.   Based on the newest studies, our understanding of
atrazine’s temporal pharmacokinetic and pharmacodynamic
characteristics has changed and it appears that shorter durations may be
appropriate.   In light of the potential need to shorten the critical
duration of exposure and as discussed by the Panel in Questions 4.1-4.3,
the Agency is evaluating appropriate methods for assessing the drinking
water monitoring data.

Previously, the Agency noted data gaps related to “information on
Atrazine concerning exposure throughout all critical developmental
periods (i.e., gestation through puberty in both sexes), in particular,
early in development…. (emphasis added, FQPA memo, 2002).”   At the
time of the previous risk assessment, there were only a few available
studies which included measures sensitive to endocrine disruption on
specific early life exposure periods (e.g., peripubertal).  Since that
time new studies have become available (Section 6.0) which add to the
existing database and support the findings of the older studies.  In
addition, new tissue dosimetry studies provide information on the
transfer of atrazine and its chlorinated metabolites to the fetus and to
the lactating pup.  Further, a study evaluating exposure to atrazine
from multiple critical developmental periods identified previously by
the Agency as a data gap is on-going.   The results of this research
will inform our understanding of the potential for differential life
stage sensitivity.

In the coming months, as the drinking water exposure analysis develops
further and the on-going toxicology studies become available, the Agency
will work towards completing the scientific analysis that will inform
whether or not a new FQPA Safety Factor should be applied in the
atrazine risk assessment.

The Agency requests the Panel to comment on important scientific factors
for the Agency to consider in its analysis.  Please include in your
comments specific consideration of uncertainties in estimating drinking
water exposures and remaining uncertainties in atrazine’s
toxicological profile across life stages, particularly as they pertain
to assessing risk to infants and children.

10:30 a.m.	Break

10:45 a.m.	Charge to Panel

Question 6.0:  Implications of MOA & Toxicity Profile on Water
Monitoring

As described in the Introduction of the draft issue Paper (Section 1),
the goals of the current atrazine re-evaluation are: 1) to determine the
extent to which new science indicates a need for the Agency to develop a
revised human health risk assessment for atrazine and 2) to re-consider,
as appropriate, the frequency of drinking water monitoring needed.  Two
important issues related to achieving these goals are determining the
point of departure and identifying the critical effect and its
associated duration of exposure.  Proposed updates to the point of
departure are considered in Questions 3.1 and 3.2.  With respect to the
critical duration of concern, the frequency of drinking water monitoring
is related to the temporal pattern of the toxicological endpoint of
concern used for the risk assessment.  Generally, longer durations of
toxicological concern (e.g., a long-term chronic effect) require a less
frequent drinking water sampling design to approximate longer term
exposures.  However, as the duration of concern shortens, the frequency
and timing of sampling become more important in determining how well the
sample data capture short-duration exposures.  Observation epidemiology
studies raise hypotheses and suggest possible links between atrazine
exposure and reproductive and developmental outcomes, but these
epidemiology studies suffer from limitations which prevent firm
conclusions.  Although certain studies some provide qualitative support
for the human relevance of the endpoints identified through the
experimental toxicological database, they provide little to no
information on the critical duration of exposure.  In addition, the MOA
and PK database are also lacking in human specific information on the
effects of atrazine which could be used to quantitatively extrapolate
between species.  As such, the information available to evaluate the
critical duration of exposure lacks quantitative precision. Thus, the
critical duration of exposure is instead derived by inferring generic
knowledge from a variety of scientific disciplines.

The Agency has used a variety of approaches to extrapolate findings from
experimental animal data to humans including allometric scaling and
human-specific information on the physiology of the menstrual cycle
inferred from the IVF literature.  According to the Agency’s analysis
of the pharmaceutical data and allometric scaling of the rodent
pharmacokinetics data, the potential durations of human exposure that
would correspond to the exposure period of interest in rats lie between
a few days to approximately 4 weeks of exposure.

Please comment on the Agency’s analysis and preliminary conclusions
contained in Section 8.0 of the draft Issue Paper as it relates to the
potential critical windows of exposure.  Please include in your comments
additional or alternative approaches or data that may inform this issue.

12:00 p.m	Lunch

1:00 p.m.	Charge to Panel continued

3:00 p.m. 	Break

3:15 p.m.	Charge to Panel continued

5:00 p.m.	Adjourn

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin.
For further information, please contact the Designated Federal Official
for this meeting, Joseph Bailey, via telephone:<PHONE_NUMBER>; fax:
(202) 564-8382; or email<EMAIL_ADDRESS>
 PAGE

 PAGE   1


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF CHEMICAL SAFETY AND

                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:  		25-AUG-2010

SUBJECT:	Acequinocyl.  Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action Use on Fruiting Vegetables, Hops, Okra, and Edible-Podded Beans.

PC Code:  006329	DP Barcode:  D369101

Decision No.:  417967	Registration No.:  66330-38

Petition No.:  9E7598	Regulatory Action:  Section 3

Risk Assessment Type:  Dietary	Case No.:  7621

TXR No.:  NA	CAS No.:  57960-19-7

MRID No.:  NA	40 CFR:  §180.599

FROM:	Sarah J. Levy, Chemist

Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

THROUGH:	Nancy Dodd, Chemist

David Soderberg, Chemist

Dietary Exposure Science Advisory Council (DESAC)/HED (7509P)

and

George F. Kramer, Ph.D., Branch Senior Scientist

Branch/Health Effects Division (7509P)

TO:		Sarah J. Levy, Chemist/Risk Assessor

		RAB1/HED (7509P)

and

Barbara Madden, RM 05

Registration Division (RD; 7505P)

Executive Summary

™, Version 2.03) which use food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analysis was performed to support a requested Section 3 registration use of the insecticide acequinocyl (2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione) on fruiting vegetables, hops, okra, and edible-podded beans.  An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established.  A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

Tolerance-level residues and 100 percent crop treated (%CT) data were used in the chronic dietary assessment.  DEEM( ver. 7.81 default processing factors were used with the exception of grape juice and raisins (see “Residue Information” Section of this document for details).  For the chronic dietary assessment, the general U.S. population and all population subgroups have risk estimates which are not of concern to HED.  The chronic dietary exposure estimate for the U.S. population is 9.8% of the chronic population-adjusted dose (cPAD).  The highest exposed population subgroup (children 1-2 years old) occupies 45% of the cPAD.  The use of anticipated residues (ARs), empirical processing factors, and %CT would refine further HED’s exposure and risk estimates; however, refinement is not needed at this time.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for acequinocyl was conducted by Sarah Levy (11-DEC-2007; DP# 347404).

II.	Residue Information

Under PP#9E7598, the Interregional Research Project No.4 (IR-4), on behalf of the Agricultural Experiment Stations of AZ, CA, CO, FL, ID, NC, NJ, NY, OK, OR, TN, TX, VA, and WA, has submitted a petition proposing the use of acequinocyl (Kanemite( 15 soluble concentrate (SC), 1.25 lb/gal), a quinoline type of miticide, on fruiting vegetables, hops, okra, and edible-podded beans.  Permanent tolerances are currently established under 40 CFR §180.599(a) for the combined residues of acequinocyl and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as acequinocyl equivalents, in/on a number of plant and livestock commodities.  Tolerances for plant commodities range from 0.02 ppm (tree nuts and pistachios) to 30 ppm (citrus oil), and tolerances for livestock commodities are established at 0.02 ppm in the fat and liver of cattle, goat, horse, and sheep.  There are residential uses (greenhouse, ornamental, etc.) for acequinocyl established as well.  Note that for this petition, there are no livestock feedstuffs associated with the proposed crop uses; therefore, re-evaluation of the registered livestock tolerance levels is not necessary at this time.

  SEQ CHAPTER \h \r 1 Based on the structural similarity of acequinocyl-OH to parent and the presence of acequinocyl-OH at quantifiable levels in crops, the HED Metabolism Assessment Review Committee (MARC) concluded that parent and acequinocyl-OH are the residues of concern for risk assessment and tolerance expression in apples, oranges, and eggplant commodities (Memo, S. Levy, 07-JAN-2004; DP# 297872).  For purposes of this petition, HED is willing to translate these results to hops and edible-podded beans as these two crops are low-consumption food items.  See Table 1 for a summary of the residues of concern determined by the MARC.

Table 1.  Residues of Concern in Crops, Ruminants, and Drinking Water.

Matrix	Tolerance Expression	Residues for Risk Assessment

Fruit Crops	Acequinocyl + Acequinocyl-OH (R1)	Acequinocyl + Acequinocyl-OH (R1)

Ruminants	Acequinocyl + Acequinocyl-OH (R1)	Acequinocyl + Acequinocyl-OH (R1).  In liver and kidney, also include AKM-15.

Rotational Crops	Not Determined*	Not Determined*

Drinking Water	NA**	Acequinocyl + Acequinocyl-OH (R1)

* A confined rotational crop study has been reviewed and a 30-day plant-back interval has been recommended (DP#351336, S. Levy, 6/25/08).

** NA = not applicable.

Residue Data used for the Chronic Assessment:

Tolerance-level residues and 100%CT data were used in the chronic dietary assessment.  DEEM( ver. 7.81 default processing factors were used with the exception of grape juice and raisins.  As residues were reduced in both grape juice (<0.02x) and raisin (0.15x), separate tolerances are not required for these commodities; therefore, the DEEM( ver. 7.81 default processing factors for juice and raisin were set to 1 as concentration was shown not to occur (Memo, S. Levy, 05-SEP-2007; DP#: 342805).  The tolerance value of 0.02 ppm for cattle, goat, horse, and sheep fat and liver was entered for meat byproducts as well, where applicable.

The use of ARs, empirical processing factors, and %CT data would refine further HED’s exposure and risk estimates.  However, refinement of the dietary exposure estimates is not needed at this time.  See Table 2 for a summary of the data used in the chronic assessment.

Table 2.  Data and Residue Estimates Used in the Acequinocyl Chronic Dietary Analyses.

Commodity	Data Source

(MRID)	%CT	Processing Factors	HED-Recommended Tolerance (ppm)

Vegetable, fruiting, group 8	47819401,

47819402

100	NA	0.70

Okra1	Translated

NA	0.70

Bean, edible podded	47819403

NA	0.25

Hop, dried cones	47819404

NA	4.0

1   Okra has been recommended to be added as a member of the fruiting vegetable group 8; however, until okra has been officially added to the crop group, a separate tolerance is required for okra at the same tolerance level (0.70 ppm) as for fruiting vegetables.

III.	Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) (I. Maher, 29-APR-2010; DP# 368426) and incorporated directly into this dietary assessment.  Water residues were incorporated directly into DEEM-FCID under the food categories “water, direct, all sources” and “water, indirect, all sources.”

Acequinocyl can reach surface water via spray drift and less likely via runoff.  Due to its high Kd values it is expected to exhibit low mobility in soil and low potential to leach into groundwater. Once acequinocyl has entered surface water, it is not likely to persist as it will hydrolyze to form hydroxy-acequinocyl (also known as OH-AKD 023, 2-hydroxy-3-dodecyl-1,4-napthelenedione (HDNQ), and R-1).

There are no drinking water monitoring data available for acequinocyl or its metabolite acequinocyl-OH (R1), the residues of concern.  Groundwater and surface water estimated drinking water concentrations (EDWCs) were generated for acequinocyl using the Screening Concentration in Ground Water (SCI-GROW) and Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) models, respectively.  Two approaches were used in performing the drinking water assessment for the proposed acequinocyl uses.  In Approach #1, acequinocyl was conservatively assumed to be stable to all routes of degradation to account for the uncertainties associated with the environmental fate data.  In Approach #2, total (acequinocyl + acequinocyl-OH) residues were modeled with the assumption that the metabolite acequinocyl-OH (referred to as the R1 degradate in this assessment) is of toxicological concern.  The highest PRZM-EXAMS surface water modeling estimates were obtained for the Pennsylvania tomato scenario for the chronic values.  The modeled EDWCs for ground and surface water are summarized in Table 3.

Table 3.  Ground and Surface Water EDWCs for Acequinocyl.

Approach #1 and #2

Groundwater EDWC for Acequinocyl + R1 (ppb)	Surface Water

	Approach #1

Acequinocyl	Approach #2

Acequinocyl + R1

	1-in-10-Year Chronic Mean Concentration (ppb)	1-in-10-Year Chronic Mean Concentration (ppb)

0.0036	2.45	0.29

Since the surface water EDWCs are higher than the groundwater EDWC, HED selected the surface water value for use in the chronic dietary assessment.  The EDWC derived via Approach #1 represents the upper-bound value (2.45 ppb) while that derived via Approach #2 represents the lower-bound value (0.29).  The 2.45 ppb value was used in the dietary modeling as this value assures a conservative assessment.

™ Program and Consumption Information

An acequinocyl chronic dietary exposure assessment was conducted using DEEM-FCID™, Version 2.03 which incorporates consumption data from USDA’s CSFII, 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

V.	Toxicological Information

On 14-OCT-2003, the HED Hazard Identification Assessment Review Committee (HIARC) reviewed the recommendations of the toxicology reviewer for acequinocyl with regard to the acute and chronic RfDs and the toxicological endpoint selection for use as appropriate in occupational/residential exposure risk assessments.  The potential for increased susceptibility of infants and children from exposure to acequinocyl was also evaluated as required by the Food Quality Protection Act (FQPA) of 1996 under the 2002 OPP 10X Guidance.  Table 4 is a summary of the toxicology doses and endpoints selected that are relevant to dietary exposure assessment (TXR# 0052234, 13-NOV-2003).  The acequinocyl risk assessment team confirmed that the endpoints selected previously remain appropriate.

Table 4.  Summary of Toxicological Doses and Endpoints for Acequinocyl for Use in Dietary Exposure Risk Assessment.1

Exposure/

Scenario	Point of Departure	Uncertainty/

FQPA Safety Factors	RfD, PAD, Level of Concern 	Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)

N/A

N/A

N/A	An endpoint of concern (effect) attributable to a single dose was not identified in the database.  Quantification of acute risk to general population including infants and children is not required.

Chronic Dietary (All Populations)	NOAEL= 2.7 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x

	cPAD = cRfD = 0.027 mg/kg/day

	18-month carcinogenicity study in mice;

LOAEL=7.0 mg/kg/day based on clinical chemistry and microscopic nonneoplastic lesions (brown pigmented cells and perivascular inflammatory cells in liver)

1  UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation in sensitivity among members of the human population (intraspecies), FQPA SF = FQPA Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose (a = acute, c = chronic), PAD = population adjusted dose, MOE = margin of exposure, LOC = level of concern, N/A = Not Applicable, UFDB = database uncertainty factor, UFL = uncertainty factor for lack of a NOAEL.

VI.	Results/Discussion

™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 5 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established.  A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans.

The chronic dietary exposure assessment (using tolerance level residues and 100% CT information for all registered and proposed uses) was conducted for the general U.S. population and various population subgroups.  Drinking water was incorporated directly into the dietary assessment using the chronic concentration for ground water generated by the PRZM/EXAMS model.  This assessment concludes that the chronic dietary exposure estimates are not of concern to HED for the general U.S. population (9.8% cPAD) and all population subgroups.  The most highly exposed population subgroup is children 1-2 years old at 45% of the cPAD.  The use of ARs, empirical processing factors, and %CT data would refine further HED’s exposure and risk estimates; however, refinement is not needed at this time.

Table 5.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for Acequinocyl.

Population Subgroup	Chronic Dietary1

	Dietary Exposure

(mg/kg/day)	% cPAD

U.S. Population (total)	0.002657	9.8

All Infants (< 1 year old)	0.005584	21

Children 1-2 years old	0.012193	45

Children 3-5 years old	0.008046	30

Children 6-12 years old	0.003657	14

Youth 13-19 years old	0.001855	6.9

Adults 20-49 years old	0.001758	6.5

Adults 50+ years old	0.001811	6.7

Females 13-49 years old	0.001808	6.7

1 Chronic dietary endpoint of 0.027 mg/kg/day applies to the general U.S. population and all population subgroups.  The values for the highest exposed population for each type of risk assessment should be bolded.

VII.	Conclusions

A chronic dietary exposure and risk assessment was conducted for the proposed food uses and permanent tolerances of acequinocyl, including potential exposure from drinking water.

The chronic dietary (food + drinking water) exposure to acequinocyl is below HED’s level of concern for the general U.S. population and all population subgroups.  The chronic dietary exposure utilized 9.8% cPAD for the general U.S. population and 45% of the cPAD for children 1-2 years old, the most highly exposed population subgroup.  An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established.  A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans.

VIII.		List of Attachments

Attachment 1:  Chronic Food plus Drinking Water Residue Input File.

Attachment 2:  Chronic Results File.

cc:  I. Maher (EFED/ERBI; 7507P)

RDI: DESAC (19-MAY-2010); G.F. Kramer (24-MAY-2010)

S. Levy:S10953:PY1:(703)305-0783:7590P

Attachment 1:  Chronic Food plus Drinking Water Residue Input File.

U.S. Environmental Protection Agency                                Ver. 2.00

DEEM-FCID Chronic analysis for ACEQUINOCYL                       1994-98 data

Residue file: C:\Documents and Settings\slevy\Desktop\Acequinocyl\006329c.R98

                                                              Adjust. #2 used

Analysis Date 05-26-2010            Residue file dated: 05-26-2010/09:02:01/8

Reference dose (RfD) = 0.027 mg/kg bw/day

Comment:No acute dietary endpoint; not carcinogen.  cRfD=cPAD

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

14000030 14   Almond                             0.020000   1.000      1.000

14000031 14   Almond-babyfood                    0.020000   1.000      1.000

14000040 14   Almond, oil                        0.020000   1.000      1.000

14000041 14   Almond, oil-babyfood               0.020000   1.000      1.000

11000070 11   Apple, fruit with peel             0.400000   1.000      1.000

11000080 11   Apple, peeled fruit                0.400000   1.000      1.000

11000081 11   Apple, peeled fruit-babyfood       0.400000   1.000      1.000

11000090 11   Apple, dried                       0.400000   8.000      1.000

11000091 11   Apple, dried-babyfood              0.400000   8.000      1.000

11000100 11   Apple, juice                       0.400000   1.300      1.000

11000101 11   Apple, juice-babyfood              0.400000   1.300      1.000

11000110 11   Apple, sauce                       0.400000   1.000      1.000

11000111 11   Apple, sauce-babyfood              0.400000   1.000      1.000

06010430 6A   Bean, snap, succulent              0.250000   1.000      1.000   9E7598

06010431 6A   Bean, snap, succulent-babyfood     0.250000   1.000      1.000   9E7598

21000460 M    Beef, meat byproducts              0.020000   1.000      1.000

21000461 M    Beef, meat byproducts-babyfood     0.020000   1.000      1.000

21000470 M    Beef, fat                          0.020000   1.000      1.000

21000471 M    Beef,fat-babyfood                  0.020000   1.000      1.000

21000490 M    Beef, liver                        0.020000   1.000      1.000

21000491 M    Beef, liver-babyfood               0.020000   1.000      1.000

14000590 14   Brazil nut                         0.020000   1.000      1.000

14000680 14   Butternut                          0.020000   1.000      1.000

14000810 14   Cashew                             0.020000   1.000      1.000

14000920 14   Chestnut                           0.020000   1.000      1.000

10001060 10   Citrus citron                      0.200000   1.000      1.000

10001070 10   Citrus hybrids                     0.200000   1.000      1.000

10001080 10   Citrus, oil                       30.000000   1.000      1.000

11001290 11   Crabapple                          0.400000   1.000      1.000

08001480 8    Eggplant                           0.700000   1.000      1.000   9E7598

14001550 14   Filbert                            0.020000   1.000      1.000

14001560 14   Filbert, oil                       0.020000   1.000      1.000

23001710 M    Goat, fat                          0.020000   1.000      1.000

95001750 O    Grape                              1.600000   1.000      1.000

95001760 O    Grape, juice                       1.600000   1.000      1.000

95001761 O    Grape, juice-babyfood              1.600000   1.000      1.000

95001770 O    Grape, leaves                      1.600000   1.000      1.000

95001780 O    Grape, raisin                      1.600000   1.000      1.000

95001790 O    Grape, wine and sherry             1.600000   1.000      1.000

10001800 10   Grapefruit                         0.200000   1.000      1.000

10001810 10   Grapefruit, juice                  0.200000   2.100      1.000

14001850 14   Hickory nut                        0.020000   1.000      1.000

95001880 O    Hop                                4.000000   1.000      1.000   9E7598

10001970 10   Kumquat                            0.200000   1.000      1.000

10001990 10   Lemon                              0.200000   1.000      1.000

10002000 10   Lemon, juice                       0.200000   2.000      1.000

10002001 10   Lemon, juice-babyfood              0.200000   2.000      1.000

10002010 10   Lemon, peel                        0.200000   1.000      1.000

10002060 10   Lime                               0.200000   1.000      1.000

10002070 10   Lime, juice                        0.200000   2.000      1.000

10002071 10   Lime, juice-babyfood               0.200000   2.000      1.000

11002100 11   Loquat                             0.400000   1.000      1.000

14002130 14   Macadamia nut                      0.020000   1.000      1.000

08002340 8    Okra                               0.700000   1.000      1.000   9E7598

10002400 10   Orange                             0.200000   1.000      1.000

10002410 10   Orange, juice                      0.200000   1.800      1.000

10002411 10   Orange, juice-babyfood             0.200000   1.800      1.000

10002420 10   Orange, peel                       0.200000   1.000      1.000

11002660 11   Pear                               0.400000   1.000      1.000

11002661 11   Pear-babyfood                      0.400000   1.000      1.000

11002670 11   Pear, dried                        0.400000   6.250      1.000

11002680 11   Pear, juice                        0.400000   1.000      1.000

11002681 11   Pear, juice-babyfood               0.400000   1.000      1.000

14002690 14   Pecan                              0.020000   1.000      1.000

08002700 8    Pepper, bell                       0.700000   1.000      1.000   9E7598

08002701 8    Pepper, bell-babyfood              0.700000   1.000      1.000   9E7598

08002710 8    Pepper, bell, dried                0.700000   1.000      1.000   9E7598

08002711 8    Pepper, bell, dried-babyfood       0.700000   1.000      1.000   9E7598

08002720 8    Pepper, nonbell                    0.700000   1.000      1.000   9E7598

08002721 8    Pepper, nonbell-babyfood           0.700000   1.000      1.000   9E7598

08002730 8    Pepper, nonbell, dried             0.700000   1.000      1.000   9E7598

14002820 14   Pistachio                          0.020000   1.000      1.000

10003070 10   Pummelo                            0.200000   1.000      1.000

11003100 11   Quince                             0.400000   1.000      1.000

26003400 M    Sheep, meat byproducts             0.020000   1.000      1.000

26003410 M    Sheep, fat                         0.020000   1.000      1.000

26003411 M    Sheep, fat-babyfood                0.020000   1.000      1.000

95003590 O    Strawberry                         0.400000   1.000      1.000

95003591 O    Strawberry-babyfood                0.400000   1.000      1.000

95003600 O    Strawberry, juice                  0.400000   1.000      1.000

95003601 O    Strawberry, juice-babyfood         0.400000   1.000      1.000

10003690 10   Tangerine                          0.200000   1.000      1.000

10003700 10   Tangerine, juice                   0.200000   2.300      1.000

08003740 8    Tomatillo                          0.700000   1.000      1.000   9E7598

08003750 8    Tomato                             0.700000   1.000      1.000   9E7598

08003751 8    Tomato-babyfood                    0.700000   1.000      1.000   9E7598

08003760 8    Tomato, paste                      0.700000   1.000      1.000   9E7598

08003761 8    Tomato, paste-babyfood             0.700000   1.000      1.000   9E7598

08003770 8    Tomato, puree                      0.700000   1.000      1.000   9E7598

08003771 8    Tomato, puree-babyfood             0.700000   1.000      1.000   9E7598

08003780 8    Tomato, dried                      0.700000   1.000      1.000   9E7598

08003781 8    Tomato, dried-babyfood             0.700000   1.000      1.000   9E7598

08003790 8    Tomato, juice                      0.700000   1.000      1.000   9E7598

14003910 14   Walnut                             0.020000   1.000      1.000

86010000 O    Water, direct, all sources         0.002450   1.000      1.000

86020000 O    Water, indirect, all sources       0.002450   1.000      1.000

Attachment 2:  Chronic Results File.

U.S. Environmental Protection Agency                                Ver. 2.00

DEEM-FCID Chronic analysis for ACEQUINOCYL                     (1994-98 data)

Residue file name: C:\Documents and Settings\slevy\Desktop\Acequinocyl\006329c.R98

                                                   Adjustment factor #2 used.

Analysis Date 05-26-2010/09:02:22   Residue file dated: 05-26-2010/09:02:01/8

Reference dose (RfD, Chronic) = .027 mg/kg bw/day

COMMENT 1: No acute dietary endpoint; not carcinogen.  cRfD=cPAD

======================================================================== =====

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.002657                 9.8%

U.S. Population (spring season)             0.002596                 9.6%

U.S. Population (summer season)             0.002685                 9.9%

U.S. Population (autumn season)             0.002656                 9.8%

U.S. Population (winter season)             0.002692                10.0%

Northeast region                            0.003098                11.5%

Midwest region                              0.002605                 9.6%

Southern region                             0.002340                 8.7%

Western region                              0.002822                10.5%

Hispanics                                   0.002932                10.9%

Non-hispanic whites                         0.002630                 9.7%

Non-hispanic blacks                         0.002535                 9.4%

Non-hisp/non-white/non-black                0.002797                10.4%

All infants (< 1 year)                      0.005584                20.7%

Nursing infants                             0.002797                10.4%

Non-nursing infants                         0.006642                24.6%

Children 1-6  yrs                           0.008946                33.1%

Children 7-12 yrs                           0.003387                12.5%

Females 13-19 (not preg or nursing)         0.001912                 7.1%

Females 20+ (not preg or nursing)           0.001808                 6.7%

Females 13-50 yrs                           0.001991                 7.4%

Females 13+ (preg/not nursing)              0.001997                 7.4%

Females 13+ (nursing)                       0.002049                 7.6%

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Children 1-2 yrs                            0.012193                45.2%

Children 3-5 yrs                            0.008046                29.8%

Children 6-12 yrs                           0.003657                13.5%

Youth 13-19 yrs                             0.001855                 6.9%

Adults 20-49 yrs                            0.001758                 6.5%

Adults 50+ yrs                              0.001811                 6.7%

Females 13-49 yrs                           0.001808                 6.7%

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

Acequinocyl	Dietary Exposure and Risk Assessment		DP# 369101

PC Code:  006329

________________________________________________________________________ ______________

Page   PAGE  1  of   NUMPAGES  11


[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)]
[Rules and Regulations]
[Page 41519]
[FR Doc No: 2017-18545]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0825]

Drawbridge Operation Regulation; Willamette River at Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Hawthorne Bridge across the
Willamette River, mile 13.1, at Portland, OR. The deviation is
necessary to accommodate the Race for the Cure event. This deviation
allows the bridge to remain in the closed-to-navigation position to
allow safe roadway movement of event participants.

DATES: This deviation is effective from 7 a.m. to noon on September 17,
2017.

ADDRESSES: The docket for this deviation, USCG-2017-0825 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Multnomah County, bridge owner, has
requested a temporary deviation from the operating schedule for the
Hawthorne Bridge across the Willamette River, mile 13.1, at Portland,
OR. The requested deviation is to accommodate the Race for the Cure
event. To facilitate this event, the draw of the subject bridge will be
allowed to remain in the closed-to-navigation position and need not
open to marine traffic from 7 a.m. to noon on September 17, 2017. The
Hawthorne Bridge provides a vertical clearance of 49 feet in the
closed-to-navigation position referenced to the vertical clearance
above Columbia River Datum 0.0. The normal operating schedule is in 33
CFR 117.897(c)(3)(v). Waterway usage on this part of the Willamette
River includes vessels ranging from commercial tug and barge to small
pleasure craft. The Coast Guard provided notice of and requested
objections to this deviation to local mariners via the Local Notice
Mariners, and email. No objections were submitted to the Coast Guard.
    Vessels able to pass through the bridge in the closed-to-navigation
position may do so at any time. The bridge will be able to open for
emergencies, and there is no immediate alternate route for vessels to
pass. The Coast Guard will inform the users of the waterway, through
our Local and Broadcast Notices to Mariners, of the change in operating
schedule for the bridge so that vessel operators can arrange their
transits to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: August 25, 2017.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2017-18545 Filed 8-31-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]
[Page 32493-32494]
[DOCID:fr08jn10-129]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID NRC-2010-0080]

NUREG-0654/FEMA-REP-, Rev. 1, Supplement 3, Guidance for
Protective Action Recommendations for General Emergencies; Draft for
Comment

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of meeting and extension of public comment period.

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SUMMARY: The Federal Emergency Management Agency (FEMA) and the Nuclear
Regulatory Commission (NRC) are reopening the comment period and
announcing the date, time and location for one in a series of public
meetings that will be held to discuss the proposed Supplement 3 to
NUREG-0654/FEMA-REP-1, Rev.1, Guidance for Protective Action
Recommendations for General Emergencies (NUREG Supp 3). NUREG Supp 3
addresses onsite and offsite nuclear power plant preparedness.

DATES: Meeting Date: The meeting will be held on Wednesday, June 9,
2010 from 1 p.m.-4 p.m. (Central Daylight Time).
    Registration Date: Those interested in participating in this
meeting by teleconference or webconference should call or e-mail the
person listed below in the FOR FURTHER INFORMATION CONTACT section as
soon as possible, but no later than 1 p.m. (Eastern Standard Time) on
Tuesday, June 8, 2010.
    Comment Period: The public comment period originally scheduled to
close on May 24, 2010, has been extended to August 9, 2010.

ADDRESSES: The meeting will be held at the Radisson Hotel La Crosse,
200 Harborview Plaza, La Crosse, Wisconsin 54601; Ph:<PHONE_NUMBER>.
    You may submit comments on the proposed Supplement 3, identified by
Docket ID NRC-2010-0080, by visiting http://www.regulations.gov. Follow
the instructions listed on how to submit comments. (Note: This process
applies to all government requests for comments--even though as in the
case of this draft guidance document, they may not be for regulatory
purposes). For further information and methods for submitting comments,
see the ``Announcement of Issuance for Public Comment, Availability''
(at 75 FR 10524, on March 8, 2010) or call or e-mail the contact person
listed below in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Michelle Ralston, Emergency

Management Specialist, Professional Services and Integration Branch,
Technological Hazards Division, Protection and National Preparedness,
<EMAIL_ADDRESS>(202) 212-2310.

SUPPLEMENTARY INFORMATION: These meetings will be conducted jointly by
the Nuclear Regulatory Commission (NRC) and the Federal Emergency
Management Agency (FEMA) and will address Supplement 3 to NUREG-0654/
FEMA-REP-1, Rev.1, Guidance for Protective Action Recommendations for
General Emergencies (NUREG Supp 3). Draft NUREG Supp 3 has been
proposed by these two agencies to address emergency planning and
preparedness for Nuclear Power Plants. This document addresses both
onsite (the plants themselves) and offsite (State, local, Tribal
offsite response organizations) planning and preparedness. FEMA and the
NRC are soliciting comments for the joint document through the notice
of availability, titled ``Announcement of Issuance for Public Comment,
Availability'' (75 FR 10524, published on March 8, 2010). The document
is available at http://www.regulations.gov (Docket ID NRC-2010-0080).
Please note that the public comment period on this document has been
extended to August 9, 2010.
    NUREG-0654/FEMA-REP-1, Rev. 1, is a joint FEMA/NRC policy document
that contains the Evaluation Criteria that FEMA and the NRC use to
determine compliance with the 16 Planning Standards that are located in
FEMA's regulations at 44 CFR 350.5, and the NRC's regulations at 10 CFR
part 50. The agencies use these Planning Standards, and associated
Evaluation Criteria, to measure the adequacy of emergency preparedness
plans of Nuclear Power Plant (NPP) owners and operators and the State,
local, and Tribal jurisdictions in which they are sited.
    NUREG Supp 3 provides additional guidance directed to NPP
licensees, State, local, and Tribal jurisdictions. Elements of this
draft guidance include increased offsite response organization
involvement in the development of protective action strategies,
consideration of staged evacuation as the initial protective action at
General Emergency, increased use of shelter-in-place for certain
scenarios, and guidance to improve communications with the public
before and during an emergency. The substance of this joint draft
guidance aligns with changes proposed in the NRC Notice of Proposed
Rulemaking entitled ``Enhancements to Emergency Preparedness
Regulations'' (74 FR 23254, published on May 18, 2009), and Interim
Staff Guidance as well as the changes proposed in FEMA's draft
Radiological Emergency Preparedness Program Manual and Supplement 4 to
NUREG-0654/FEMA-REP-1, Rev.1 (74 FR 23198 published on May 18, 2009).
    The purpose of these public meetings is to (1) Introduce the
proposed draft guidance jointly; (2) answer questions about the
proposed draft guidance document and to describe the next steps in the
guidance document process; (3) ensure openness during the guidance
document process; (4) provide additional opportunities for public
participation in the guidance document process; and, (5) build positive
relations, confidence, and trust in the guidance document process.
    Public Meeting Date, Time, and Location:
    Wednesday, June 9, 2010.
    Meeting Location: Radisson Hotel La Crosse, 200 Harborview Plaza,
La Crosse, Wisconsin 54601; Ph:<PHONE_NUMBER>.
    Times: 1 p.m.-4 p.m. (Central Daylight Time); Please note that the
meeting may close early if all business is finished.
    Two additional meetings, with precise times and locations yet to be
determined, are tentatively scheduled for the month of July, 2010. When
these meeting times and locations are confirmed, a notice will be
published in the Federal Register.
    Teleconferencing: Interested members of the public unable to attend
the meeting may participate by telephone via a toll-free
teleconference. For details, please call the contact person listed in
the FOR FURTHER INFORMATION CONTACT section. Those interested in
participating in this meeting by teleconference should call or email
the person listed in the FOR FURTHER INFORMATION CONTACT section as
soon as possible, but no later than 1 p.m. (Eastern Standard Time) on
Tuesday, June 8, 2010.
    Webconferencing: Interested members of the public unable to attend
the meeting may participate remotely on the internet. For details,
please call the contact person listed in the FOR FURTHER INFORMATION
CONTACT section as soon as possible, but no later than 1 p.m. (Eastern
Standard Time) on Tuesday, June 8, 2010.

Information on Services for Individuals With Disabilities

    FEMA provides reasonable accommodations to individuals with
disabilities where appropriate. If you need a reasonable accommodation
to participate in this meeting (e.g., sign language), or need this
meeting notice or other information from the meeting in another format,
please notify the person listed above in the FOR FURTHER INFORMATION
CONTACT section as soon as possible so that arrangements can be made.

Timothy W. Manning,
Deputy Administrator, Protection and National Preparedness, Federal
Emergency Management Agency.
[FR Doc. 2010-13711 Filed 6-7-10; 8:45 am]
BILLING CODE 9110-21-P


[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Notices]
[Page 34527]
[DOCID:fr17jn10-148]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Volkswagen Petition for Exemption From the Vehicle Theft
Prevention Standard; Correction

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice; correction.

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

SUMMARY: The National Highway Traffic Safety Administration (NHTSA)
published a document in the Federal Register of May 27, 2010, granting
in full Volkswagen Group of America's (Volkswagen) petition for an
exemption of a new [confidential nameplate] vehicle line in accordance
with 49 CFR part 543, Exemption from the Theft Prevention Standard.
This document corrects the model year of the new Volkswagen vehicle
line published in the ``Summary'' section. All previous information
associated with the published notice remains the same.

FOR FURTHER INFORMATION CONTACT: Ms. Carlita Ballard, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, 1200
New Jersey Avenue, SE., Washington, DC 20590. Ms. Ballard's telephone
number is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

Correction

    In the Federal Register of May 27, 2010, in FR Doc. 2010-12809, on
page 29814, in the first column, correct the ``Summary'' section to
read:
SUMMARY: This document grants in full the Volkswagen Group of America
(Volkswagen) petition for an exemption of the new vehicle line
[confidential nameplate] in accordance with 49 CFR part 543, Exemption
from the Theft Prevention Standard. This petition is granted because
the agency has determined that the antitheft device to be placed on the
line as standard equipment is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts marking
requirements of the Theft Prevention Standard (49 CFR part 541).
Volkswagen requested confidential treatment for the information it
submitted in support of its petition until the market introduction of
its new MY 2012 vehicle line (expected to be not later than December
2011). The agency addressed Volkswagen's request for confidential
treatment by letter dated April 30, 2010.

    Issued on: June 11, 2010.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. 2010-14575 Filed 6-16-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 85, Number 73 (Wednesday, April 15, 2020)]
[Proposed Rules]
[Page 20909]
[FR Doc No: 2020-07818]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 147

[EPA-R05-OW-2019-0705; FRL-10007-93-Region 5]

Request for Comments on Michigan Underground Injection Control
Class II Program Application

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period and public hearing.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) gives public
notice that the EPA has received a complete application from the State
of Michigan requesting federal authorization for its Underground
Injection Control (UIC) Program for wells that are used only to inject
fluids associated with oil and natural gas production, known as Class
II injection wells. EPA has determined the application contains all the
required elements. EPA approval of this application would allow the
Michigan Department of Environment, Great Lakes, and Energy to regulate
all Class II injection wells in Michigan except for those on ``Indian
lands.'' See the ADDRESSES section for information on how to access the
application documents. Public comments are requested, and a public
hearing is scheduled.

DATES: Comments will be accepted on or before June 5, 2020. A public
hearing will be held before that date. For additional information
regarding the public hearing, please see the SUPPLEMENTARY INFORMATION
section or contact Anna Miller, UIC Section, U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
ADDRESSES: You may send comments, identified by Agency Docket ID No.
EPA-R05-OW-2019-0705, by any of the following methods:
     Federal Portal (our preferred method): https://www.regulations.gov/docket?D=EPA-R05-OW-2019-0705. Follow the online
instructions for submitting comments.
     Mail: U.S. Environmental Protection Agency Region 5, UIC
Section, WP-16J, ATTN: Michigan Class II Application Docket, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    Instructions: All submissions received must include the Docket ID
Number, EPA-R05-OW-2019-0705. Comments received may be posted without
change to https://www.regulations.gov/, including any personal or
confidential business information provided. For detailed instructions
on sending comments and additional information on the rulemaking
process, see the ``Public Participation'' heading of the SUPPLEMENTARY
INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Anna Miller, UIC Section, U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Summary

    The State of Michigan has submitted an application pursuant to
section 1425 of the Safe Drinking Water Act and 40 CFR part 147 to
regulate Class II injection wells in the State. EPA approval of this
application would allow the Michigan Department of Environment, Great
Lakes, and Energy (EGLE) to regulate all Class II injection wells in
Michigan except for those on ``Indian lands.''
    EPA has determined that the application is complete because it
contains all of the requirements including: A letter from the Governor
requesting program approval; a complete description of the State
Underground Injection Control program; a statement of legal authority;
a memorandum of agreement between the State of Michigan and the EPA,
Region 5; and copies of all applicable rules and forms. This notice is
not an EPA decision or action to approve or disapprove the application;
EPA is requesting comments on the application prior to making a
decision to approve or disapprove the application.

II. Documents for Review

    Publicly available docket materials are available electronically in
www.regulations.gov/docket?D=EPA-R05-OW-2019-0705. Materials are also
available in hard copy at the following location: EGLE Lansing office
at Constitution Hall, 525 West Allegan Street, Lansing, Michigan 48909,
during business hours and subject to any office closures. Contact Mark
Snow at<PHONE_NUMBER> or at<EMAIL_ADDRESS>for more information.

III. Public Participation

A. Written comments

    Submit your comments, identified by Docket ID No. EPA-R05-OW-2019-
0705, at https://www.regulations.gov or the other methods identified in
the ADDRESSES section. Once submitted, comments cannot be edited or
withdrawn. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
the full EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

B. Public Hearing

    A public hearing has been scheduled for those who wish to deliver
comments orally. The hearing is scheduled for May 27, 2020 at the
Kirtland Community College Event Center, 4800 W Four Mile Road,
Grayling, MI 49738, from 6:30 p.m. to 9:30 p.m. local time.

    Note:  EPA may change the format and time for the May 27 hearing
to virtual and regular business hours if appropriate to protect
public health in the face of Coronavirus Disease 2019 (COVID 19)
risks. EPA will publish notice of any such change on or before May
20, 2020 exclusively at: https://www.epa.gov/uic/underground-injection-control-epa-region-5-il-mi-mn-oh-and-wi#public-notices.

    EPA will make every effort to accommodate all speakers who register
to speak. The EPA will not respond to the oral comments at that time.
Written statements and supporting information submitted during the
comment period will be considered with the same weight as oral comments
and supporting information presented at the public hearing. EPA
encourages commenters to provide EPA with a copy of their oral
testimony electronically or in hard copy form.

    Dated: April 8, 2020.
Kurt Thiede,
Regional Administrator, Region 5.
[FR Doc. 2020-07818 Filed 4-14-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Rules and Regulations]
[Pages 10498-10499]
[FR Doc No: 2016-04472]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2016-0081]

Safety Zones; Fireworks Events in Captain of the Port New York
Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce various safety zones within the
Captain of the Port New York Zone on the specified dates and times.
This action is necessary to ensure the safety of vessels and spectators
from hazards associated with fireworks displays. During the enforcement
period, no person or vessel may enter the safety zones without
permission of the Captain of the Port (COTP).

DATES: The regulation for the safety zones described in 33 CFR 165.160
will be enforced on the dates and times listed in the table in
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Petty Officer First Class Ronald Sampert U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones listed in 33 CFR 165.160 on the specified dates and times as
indicated in Table 1 below. This regulation was published in the
Federal Register on November 9, 2011 (76 FR 69614).

                                 Table 1
------------------------------------------------------------------------

------------------------------------------------------------------------
1. Relevent Partners, LLC, Pier 54,       Launch site: A barge
 Hudson River Safety Zone, 33 CFR         located in approximate
 165.160(5.8).                            position 40[deg]44'31'' N.
                                          074[deg]01'00'' W. (NAD 1983),
                                          approximately 380 yards west
                                          of Pier 54, Manhattan, New
                                          York. This Safety Zone is a
                                          360-yard radius from the
                                          barge.
                                          Date: February 19,
                                          2016.
                                          Time: 8:30 p.m.-10
                                          p.m.
2. Novo Nordisk, Ellis Island Safety      Launch site: A barge
 Zone, 33 CFR 165.160(2.2).               located between Federal
                                          Anchorages 20-A and 20-B, in
                                          approximate position
                                          40[deg]41'45'' N.
                                          074[deg]02'09'' W. (NAD 1983)
                                          about 365 yards east of Ellis
                                          Island. This Safety Zone is a
                                          360-yard radius from the
                                          barge.
                                          Date: March 10, 2016.
                                          Time: 8:45 p.m.-10
                                          p.m.
3. American Portfolios Holding, Inc.,     Launch site: A barge
 Ellis Island Safety Zone, 33 CFR         located between Federal
 165.160(2.2).                            Anchorages 20-A and 20-B, in
                                          approximate position
                                          40[deg]41'45'' N.
                                          074[deg]02'09'' W. (NAD 1983)
                                          about 365 yards east of Ellis
                                          Island. This Safety Zone is a
                                          360-yard radius from the
                                          barge.
                                          Date: May 14, 2016.
                                          Time: 9:00 p.m.-10:10
                                          p.m.
4. City of Poughkeepsie, Independence     Launch site: A barge
 Day Celebration, Poughkeepsie, NY,       located in approximate
 Hudson River Safety Zone, 33 CFR         position 41[deg]42'24.50'' N.
 165.160(5.13).                           073[deg]56'44.16 '' W. (NAD
                                          1983), approximately 420 yards
                                          north of the Mid Hudson
                                          Bridge. This Safety Zone is a
                                          300-yard radius from the
                                          barge.
                                          Date: July 4, 2016.
                                          Time: 8:30 p.m.-10:30
                                          p.m.
5. City of Yonkers July 4th Fireworks,    Launch site: A barge
 Yonkers, NY, Hudson River Safety Zone,   located in approximate
 33 CFR 165.160(5.5).                     position 40[deg]56'14.5'' N.
                                          073[deg]54'33'' W. (NAD 1983),
                                          approximately 475 yards
                                          northwest of the Yonkers
                                          Municipal Pier, New York. This
                                          Safety Zone is a 360-yard
                                          radius from the barge.
                                          Date: July 04, 2016.
                                          Time: 08:45 p.m.-10:15
                                          p.m.
6. Intrepid Museum Fireworks Display,     Launch site: A barge
 Pier 84 Hudson River Safety Zone, 33     located in approximate
 CFR 165.160(5.9).                        position 40[deg]45'56.9'' N.
                                          074[deg]00'25.4'' W. (NAD
                                          1983), approximately 380 yards
                                          west of Pier 84, Manhattan,
                                          New York. This Safety Zone is
                                          a 360-yard radius from the
                                          barge.
                                          Date: May 7, 2016.
                                         Time: 8:20 p.m.-9:30 p.m.
------------------------------------------------------------------------

    Under the provisions of 33 CFR 165.160, vessels may not enter the
safety zones unless given permission from the COTP or a designated
representative. Spectator vessels may transit outside the safety zones
but may not anchor, block, loiter in, or impede the transit of other
vessels. The Coast Guard may be assisted by other Federal, State, or
local law enforcement agencies in enforcing this regulation.

    This notice is issued under authority of 33 CFR 165.160(a) and 5
U.S.C. 552 (a). In addition to this notice in the Federal Register, the
Coast Guard will provide mariners with advanced notification of
enforcement periods via the Local Notice to Mariners and marine
information broadcasts. If the COTP determines that a safety zone need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the safety zone.

    Dated: February 9, 2016.
M.H. Day,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2016-04472 Filed 2-29-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 194 (Tuesday, October 6, 2020)]
[Notices]
[Pages 63107-63108]
[FR Doc No: 2020-22034]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-503-000]

Northern Natural Gas Company; Notice of Schedule for
Environmental Review of the Northern Lights 2021 Expansion Project

    On July 31, 2020, Northern Natural Gas Company (Northern) filed an
application in Docket No. CP20-503-000 requesting a Certificate of
Public Convenience and Necessity and authorization pursuant to Section
7 of the Natural Gas Act to construct, modify, replace, and operate
certain natural gas pipeline facilities in Minnesota. The proposed
project is known as the Northern Lights 2021 Expansion Project
(Project) and would provide 45,693 dekatherms per day (Dth/day) of
incremental winter peak day firm service for residential, commercial,
and industrial customers in Northern's Market Area.
    On August 12, 2020, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--December 15, 2020
90-day Federal Authorization Decision--Deadline March 15, 2021

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    The Northern Lights 2021 Expansion Project would consist of the
following facilities in Minnesota:
     The Willmar D Branch Line Extension (about 0.8 mile of 24-
inch-diameter pipeline) in Dakota and Scott counties;
     the Carlton Interconnect Loop (about 0.7 mile of 24-inch-
diameter pipeline) in Carlton County;
     replacement of 425 feet of 8-inch-diameter pipeline on the
Viking Interconnect Branch Line with a 12-inch-diameter branch line of
the same length, in Morrison County;
     a new greenfield natural gas-fired Hinckley Compressor
Station in Pine County, which would include one 11,153-horsepower
natural gas-fired turbine, one gas heating skid, and one natural gas-
fired backup electric generator;
     modification of the Pierz Compressor Station in Morrison
County, including a 1,100 horsepower electric motor-driven compressor
unit; and
     appurtenant facilities including one new pig \1\ receiver
and one new pig

launcher, and associated piping and valves.
---------------------------------------------------------------------------

    \1\ A pig is a tool that the pipeline company inserts into and
pushes through the pipeline for cleaning the pipeline, conducting
internal inspections, or other purposes.
---------------------------------------------------------------------------

Background

    On July 9, 2020, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Planned Northern Lights
2021 Expansion Project and Request for Comments on Environmental Issues
(NOI). The NOI was issued during the pre-filing review of the Project
in Docket No. PF20-1-000 and was sent to affected landowners; federal,
state, and local government agencies; elected officials; environmental
and public interest groups; Native American tribes; other interested
parties; and local libraries and newspapers. In response to the NOI,
the Commission received comments from the U.S. Environmental Protection
Agency, the Minnesota Department of Transportation, the Minnesota
Pollution Control Agency, City of Hinckley, International Union of
Operating Engineers, and two landowners. The primary issues raised by
the commentors include compressor station noise and vibration, tree
clearing, roadway crossings, water resources and wetlands, farmland,
and socioeconomic impacts. All substantive comments will be addressed
in the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, select General
Search from the eLibrary menu, enter the selected date range and Docket
Number excluding the last three digits (i.e., CP20-503), and follow the
instructions. For assistance with access to eLibrary, the helpline can
be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>The eLibrary link on the FERC website also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: September 30, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-22034 Filed 10-5-20; 8:45 am]
BILLING CODE 6717-01-P