[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76582-76583]
[FR Doc No: 2020-26255]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4248]

Barry J. Cadden: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Barry J. Cadden from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Cadden was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Cadden was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. As of July 9,
2020 (30 days after receipt of the notice), Mr. Cadden had not
responded. Mr. Cadden's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is applicable November 30, 2020.

ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857<EMAIL_ADDRESS>or at 240-
402-8743.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act. On June 27, 2017, Mr. Cadden was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the District of
Massachusetts, after a jury verdict, for one count of racketeering in
violation of 18 U.S.C. 1962(c), one count of racketeering conspiracy in
violation of 18 U.S.C. 1962(d), 52 counts of mail fraud in violation of
18 U.S.C. 1341, and three counts of introduction of misbranded drugs
into interstate commerce with the intent to defraud and mislead-no
prescriptions in violation of 21 U.S.C. 353(b)(1), 331(a), and
333(a)(2).
    As contained in counts 1-2, 4-39, 41-56, 95, and 99-100 of the
indictment, filed on December 16, 2014, Mr. Cadden was an owner and
director of the New England Compounding Center (NECC), which held
itself out as a compounding-only pharmacy, and he served as NECC's
president, head pharmacist, and Manager of Record. In addition, Mr.
Cadden was an owner and director of Medical Sales Management, Inc.
(MSM), and served as MSM's Treasurer. MSM provided sales and
administrative services to NECC for which MSM was paid a service fee.
MSM's sales representatives sold drugs on behalf of NECC to customers
throughout the country. In those capacities, Mr. Cadden instructed the
MSM sales force to falsely represent to customers that NECC was
providing the highest quality compounded medications, when in fact Mr.
Cadden, among other things, failed to properly sterilize drug products
consistent with applicable U.S. Pharmacopeia standards, failed to test
purportedly sterile drugs, authorized the shipping of drugs before test
results confirming their sterility were returned, never notified
customers of nonsterile results, and compounded drugs with expired
ingredients. Additionally, Mr. Cadden directed and authorized the
shipping and mailing, in interstate commerce, of contaminated
methylprednisolone acetate to NECC customers nationwide. Mr. Cadden
also caused drugs to be introduced and delivered into interstate
commerce without the valid prescription of a practitioner licensed by
law to administer drugs, which act resulted in the drugs being
misbranded. Further, Mr. Cadden defrauded the United States by
interfering with and obstructing the lawful governmental functions of
FDA by claiming to be a pharmacy dispensing drugs pursuant to valid,
patient-specific prescriptions. In fact, NECC routinely dispensed drugs
in bulk without valid, patient-specific prescriptions.
    As a result of this conviction, FDA sent Mr. Cadden, by certified
mail on June 2, 2020, a notice proposing to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(B) of the FD&C Act, that Mr. Cadden was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. The proposal also
offered Mr. Cadden an opportunity to request a hearing, providing him
30 days from the date of receipt of the letter in which to file the
request, and advised him that failure to request a hearing constituted
an election not to use the opportunity for a hearing and a waiver of
any contentions concerning this action. Mr. Cadden received the
proposal on June 9, 2020. Mr. Cadden did not request a hearing within
the timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and any contentions concerning his debarment
(21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Barry J.
Cadden, has been convicted of a felony under Federal law for conduct
otherwise relating to the regulation of a drug product under the FD&C
Act.
    As a result of the foregoing finding, Barry J. Cadden, is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application, effective
(see DATES) (see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C
Act). Any person with an approved or pending drug product application
who knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Barry J. Cadden, in any capacity during
his debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Cadden
provides services in any capacity to a person with an approved or
pending drug product application during his period of debarment, he
will be subject to civil money penalties (section 307(a)(7) of the FD&C
Act). In addition, FDA will not accept or review any abbreviated new
drug applications from Mr. Cadden during his period of debarment, other
than in connection with an audit under section 306 of the FD&C Act
(section 306(c)(1)(B) of the FD&C Act). Note that, for purposes of
section 306 of the FD&C Act, a ``drug product'' is defined as a drug
subject to regulation under section 505, 512, or 802 of the FD&C Act
(21 U.S.C. 355, 360b, 382) or under section 351 of the Public Health
Service Act (42 U.S.C. 262) (section 201(dd) of the FD&C Act (21 U.S.C.
321(dd))).
    Any application by Mr. Cadden for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2019-N-4248 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.

    Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26255 Filed 11-27-20; 8:45 am]
BILLING CODE 4164-01-P


" Leister, Mike" < MELeister@ MAPLLC. com> Received Date: 02/ 13/ 2004 12: 49: 24 PM Transmission Date: 02/ 13/ 2004 12: 49: 24 PM To: Jeff Herzog/ AA/ USEPA/ US@ EPA, Andrea. Grant@ piperrudnick. com cc: Subject: RE: Another wrinkle in the NR rule exclusion area concept Andrea, I have had a hard time reaching you so I will explain my request via email. There are several terminals along the Ohio river that supply marine fuel to water borne traffic. Most of this fuel is used outside of the proposed marker exclusion area but several of the terminals are located in Pa on the short piece of the river west of Pittsburgh in Beaver county. In addition, there are a couple of terminals on the Monongahela that deal almost entirely with locomotive diesel fuel. These are in Washington county, which is south of Pittsburgh. These terminals and their customers have expressed an interest in using credit based or small refiner high sulfur diesel for marine and locomotive applications. Under EPA's exclusion area concept they would be forced to purchase < 500 ppm sulfur diesel fuel. These two counties, which are not in Pittsburgh, are the only counties that I am requesting to be removed from the exclusion area. Please let me know what you think.

Michael E. Leister Fuels Technology Manager Marathon Ashland Petroleum LLC Phone: 419 421 2674 Fax: 419 421 4232 Email: MELeister@ MAPLLC. com  Original Message From: Herzog. Jeff@ epamail. epa. gov [ mailto: Herzog. Jeff@ epamail. epa. gov] Sent: Monday, February 09, 2004 4: 16 PM To: Andrea. Grant@ piperrudnick. com Cc: Leister, Mike Subject: Another wrinkle in the NR rule exclusion area concept Andrea, Mike related that he thought that the desire of the terminals around Pittsburgh for access to high sulfur credit and small refiner locomotive fuel might outweigh their concerns re the cost of adding injection equipment to add the marker to heating oil. Thus, Mike was wondering whether it would make sense to take the counties around Pittsburgh out of the exclusion area. This is tough one to figure given that there are so many terminals around Pittsburgh and the aim of the exclusion area concept was to keep as many heating oil terminals in the exclusion area as possible. I encouraged Mike to talk with you about the idea. What do you think your terminal facility members in the Pittsburgh area would prefer?

Thanks Jeffrey A. Herzog, Mechanical Engineer United States Environmental Protection Agency National Vehicle and Fuel Emissions Laboratory Assessment and Standards Division 2000 Traverwood Drive Ann Arbor, Michigan, 48105 Phone: ( 734) 214 4227 Fax: ( 734) 214 4816 E Mail: herzog. jeff@ epa. gov


Chapter 1: Introduction and Background

Synopsis

This document estimates the incremental costs and monetized human health
and welfare benefits of attaining possible revised primary ozone
National Ambient Air Quality Standards (NAAQS) nationwide.  This
document contains illustrative analyses that consider limited emission
control scenarios that states, tribes and regional planning
organizations might implement to achieve a revised ozone NAAQS.  In some
cases, EPA weighed the available empirical data to make judgments
regarding the proposed attainment status of certain urban areas in the
future.  According to the Clean Air Act, EPA must use health-based
criteria in setting the NAAQS and cannot consider estimates of
compliance cost.  This Regulatory Impact Analysis (RIA) is intended both
to provide the public a sense of the benefits and costs of meeting new
alternative ozone NAAQS, and to meet the requirements of Executive Order
12866.

	Background

Two sections of the Clean Air Act (“Act”) govern the establishment
and revision of NAAQS.  Section 108 (42 U.S.C. 7408) directs the
Administrator to identify pollutants which “may reasonably be
anticipated to endanger public health or welfare,” and to issue air
quality criteria for them.  These air quality criteria are intended to
“accurately reflect the latest scientific knowledge useful in
indicating the kind and extent of all identifiable effects on public
health or welfare which maybe expected from the presence of [a]
pollutant in the ambient air.”  Ozone is one of six pollutants for
which EPA has developed air quality criteria.

Section 109 (42 U.S.C. 7409) directs the Administrator to propose and
promulgate “primary” and “secondary” NAAQS for pollutants
identified under section 108.  Section 109(b)(1) defines a primary
standard as “the attainment and maintenance of which in the judgment
of the Administrator, based on [the] criteria and allowing an adequate
margin of safety, [are] requisite to protect the public health.”  A
secondary standard, as defined in section 109(b)(2), must “specify a
level of air quality the attainment and maintenance of which in the
judgment of the Administrator, based on [the] criteria, [are] requisite
to protect the public welfare from any known or anticipated adverse
effects associated with the presence of [the] pollutant in the ambient
air.”  Welfare effects as defined in section 302(h) [42 U.S.C 7602(h)]
include but are not limited to “effects on soils, water, crops,
vegetation, manmade materials, animals, wildlife, weather, visibility
and climate, damage to and deterioration of property, and hazards to
transportation, as well as effects on economic values and on personal
comfort and well-being.”

Section 109(d) of the Act directs the Administrator to review existing
criteria and standards at 5-year intervals.  When warranted by such
review, the Administrator is to retain or revise NAAQS.  After
promulgation or revision of the NAAQS, the standards are implemented by
the States.

1.2  	Role of the Regulatory Impact Analysis in the NAAQS Setting
Process

1.2.1 Legislative roles

In setting primary ambient air quality standards, EPA’s responsibility
under the law is to establish standards that protect public health.  The
Clean Air Act requires EPA, for each criteria pollutant, to set a
standard that protects public health with “an adequate margin of
safety.”  As interpreted by the Agency and the courts, the Act
requires EPA to create standards based on health considerations only.
Economic factors cannot be considered.

The prohibition against the consideration of cost in the setting of the
primary air quality standard, however, does not mean that costs or other
economic considerations are unimportant or should be ignored.  The
Agency believes that consideration of costs and benefits are essential
to making efficient, cost effective decisions for implementation of
these standards.  The impact of cost and efficiency are considered by
states during this process, as they decide what timelines, strategies,
and policies make the most sense.  Thus, this RIA is intended to inform
the public about the potential costs and benefits that may result when a
new ozone standard is implemented, but it is not relevant to
establishing the standards themselves.

1.2.2 Role of Statutory and Executive Orders

There are several statutory and executive orders that dictate the manner
in which EPA considers rulemaking and public documents.  This document
is separate from the NAAQS decision making process, but there are
several statutes and executive orders that still apply to any public
documentation.  A summary of the pertinent orders is included in
Appendix 1.  The analysis required by these statutes and executive
orders is presented in Chapter 9.

EPA presents this analysis pursuant to Executive Order 12866 and the
guidelines of OMB Circular A-4.   These documents present guidelines for
EPA to assess the benefits and costs of the selected regulatory option,
as well as one less stringent and one more stringent option. OMB
circular A-4 also requires both a cost-benefit, and a cost-effectiveness
analysis for rules where health is the primary effect.

1.2.3 Market Failure or Other Social Purpose

OMB Circular A-4 indicates that one of the reasons a regulation such as
this one may be issued is to address market failure. The major types of
market failure include: externality, market power, and inadequate or
asymmetric information.  Correcting market failures is a reason for
regulation, but it is not the only reason.  Other possible
justifications include improving the functioning of government, removing
distributional unfairness, or promoting privacy and personal freedom.

An externality occurs when one party’s actions impose uncompensated
benefits or costs on another party.  Environmental problems are a
classic case of externality.  For example, the smoke from a factory may
adversely affect the health of local residents while soiling the
property in nearby neighborhoods.  If bargaining was costless and all
property rights were well defined, people would eliminate externalities
through bargaining without the need for government regulation.  From
this perspective, externalities arise from high transaction costs and/or
poorly defined property rights that prevent people from reaching
efficient outcomes through market transactions.

Firms exercise market power when they reduce output below what would be
offered in a competitive industry in order to obtain higher prices.
They may exercise market power collectively or unilaterally.  Government
action can be a source of market power, such as when regulatory actions
exclude low-cost imports.  Generally, regulations that increase market
power for selected entities should be avoided.  However, there are some
circumstances in which government may choose to validate a monopoly.  If
a market can be served at lowest cost only when production is limited to
a single producer of local gas and electricity distribution services, a
natural monopoly is said to exist.  In such cases, the government may
choose to approve the monopoly and to regulate its prices and/or
production decisions.  Nevertheless, it should be noted that
technological advances often affect economies of scale.  This can, in
turn, transform what was once considered a natural monopoly into a
market where competition can flourish.

Market failures may also result from inadequate or asymmetric
information.  Because information, like other goods, is costly to
produce and disseminate, an evaluation will need to do more than
demonstrate the possible existence of incomplete or asymmetric
information.  Even though the market may supply less than the full
amount of information, the amount it does supply may be reasonably
adequate and therefore not require government regulation.  Sellers have
an incentive to provide information through advertising that can
increase sales by highlighting distinctive characteristics of their
products.  Buyers may also obtain reasonably adequate information about
product characteristics through other channels, such as a seller
offering a warranty or a third party providing information.

There are justifications for regulations in addition to correcting
market failures.  A regulation may be appropriate when there are clearly
identified measures that can make government operate more efficiently.
In addition, Congress establishes some regulatory programs to
redistribute resources to select groups.  Such regulations should be
examined to ensure that they are both effective and cost-effective.
Congress also authorizes some regulations to prohibit discrimination
that conflicts with generally accepted norms within our society.
Rulemaking may also be appropriate to protect privacy, permit more
personal freedom or promote other democratic aspirations.

From an economics perspective, setting an air quality standard is a
straightforward case of addressing an externality, in this case where
firms are emitting pollutants which cause health and environmental
problems without compensation for those suffering the problems.
Although this economics perspective is reflected in Clean Air Act
legislative history, there is also legislative history in which members
of Congress stated that the purpose of setting national air quality
standards solely based on health considerations (without considering
costs) is to protect a fundamental right of Americans to be protected
from air pollution levels that adversely affect their health. Setting a
standard with a reasonable margin of safety attempts to place the cost
of control on those who emit the pollutants and lessens the impact on
those who suffer the health and environmental problems from higher
levels of pollution.

1.2.4 Illustrative Nature of the Analysis

This ozone NAAQS RIA is an illustrative analysis that provides useful
insights into a limited number of emissions control scenarios that
states might implement to achieve a revised ozone NAAQS.  Because states
are ultimately responsible for implementing strategies to meet any
revised standard, the control scenarios in this RIA are necessarily
hypothetical in nature.  They are not forecasts of expected future
outcomes.  Important uncertainties and limitations, are documented in
the relevant portions of the analysis.

The illustrative goals of this RIA are somewhat different from other EPA
analyses of national rules, or the implementation plans states develop,
and the distinctions are worth brief mention.  This RIA does not assess
the regulatory impact of an EPA-prescribed national or regional rule
such as the Clean Air Interstate Rule, nor does it attempt to model the
specific actions that any state would take to implement a revised ozone
standard.  This analysis attempts to estimate the costs and human and
welfare benefits of cost-effective implementation strategies which might
be undertaken to achieve national attainment of new standards.  These
hypothetical strategies represent a scenario where states use one set of
cost-effective controls to attain a revised ozone NAAQS.  Because
states—not EPA—will implement any revised NAAQS, they will
ultimately determine appropriate emissions control scenarios.  State
implementation plans would likely vary from EPA’s estimates due to
differences in the data and assumptions that states use to develop these
plans.

The illustrative attainment scenarios presented in this RIA were
constructed with the understanding that there are inherent uncertainties
in projecting emissions and controls.  Furthermore, certain emissions
inventory, control, modeling and monitoring limitations and
uncertainties inhibit EPA’s ability to model full attainment in all
areas.  An additional limitation is that this analysis is carried out
for the year 2020, before some areas are required to reach the current
ozone standard.  Section 1.3.1 below explains why EPA selected the
analysis year of 2020.  Despite these limitations, EPA has used the best
available data and methods to produce this RIA.

	Overview and Design of the RIA

This Regulatory Impact Analysis evaluates the costs and benefits of
hypothetical national strategies to attain several potential revised
primary ozone standards.  The document is intended to be straightforward
and written for the lay person with a minimal background in chemistry,
economics, and/or epidemiology.  Figure 1.1 provides an illustration of
the framework of this RIA.

Figure 1.1: the process used to create this RIA

Baseline and years of analysis

The analysis year for this regulatory impact analysis is 2020, which
allows EPA to build the ozone RIA analysis on the previously completed
PM NAAQS RIA analysis.  Many areas will attain the current ozone
standard or any alternative standard by 2020.  For purposes of this
analysis, we assume attainment by 2020 for all areas except for two
areas in California with unique circumstances described in chapter 4.
Some areas for which we assume 2020 attainment may in fact need more
time to meet one or more of the analyzed standards, while others will
need less time.  This analysis does not prejudge the attainment dates
that will  ultimately be assigned to individual areas under the Clean
Air Act, which contains a variety of potential dates and flexibility to
move to later dates (up to 20 years), provided that the date is as
expeditious as practicable.

The methodology first estimates what baseline ozone levels might look
like in 2020 with existing Clean Air Act programs, including application
of controls to meet the current ozone standard and the newly revised PM
NAAQS standard. and then models how ozone levels would be predicted to
change following the application of additional controls to reach a
tighter standard.  This allows for an analysis of the incremental change
between the current standard and an alternative standard.  This timeline
is also consistent with expected attainment in 2020 of the revised
Particulate Matter (PM) NAAQS covered in the PM NAAQS RIA issued in
September 2006.  As explained in Chapter 2, since one of  the principal
precursors for ozone, NOx, is also a precursor for PM, it is important
that we account for the impact on ozone concentrations of  NOx controls
used in the hypothetical control scenario used in the PM NAAQS RIA, so
as to avoid double counting the benefits and costs of these controls.

1.3.2 Control Scenarios considered in this RIA

A hypothetical control strategy was developed for an alternative 8-hr
ozone standard of 0.070 ppm, in order to illustrate one national
scenario for how such a tighter standard might be met.   First, EPA
modeled the predicted air quality changes that would result from the
application of emissions control options that are known to be available
to different types of sources in portions of the country that were
predicted to be in non-attainment with 0.070 ppm in 2020.  However,
given the limitations of current technology and the amount of
improvement in air quality needed to reach a standard of 0.070 ppm in
some areas, it was also expected that modeling these known controls
would not reduce ozone concentrations sufficiently to allow all areas to
reach the more stringent standard.  This required a second step to
calculate the number of tons of emission reductions that would be needed
to reach full attainment.  This required calculating a conversion factor
to quantify the estimated tons of emissions that needed to be reduced to
generate a particular change in air quality concentrations of ozone (in
ppm).  This factor, coupled with the estimated remaining increment (in
ppm) of ozone necessary to reach the alternative standard in each area,
allowed for an extrapolation of how many tons of additional emissions
reductions were estimated to be needed to reach the alternate standard.

1.3.3 Evaluating Costs and Benefits

Applying a two step methodology for estimating emission reductions
needed to reach full attainment enabled EPA to evaluate nationwide costs
and benefits of attaining a tighter ozone standard, albeit with
substantial additional uncertainty regarding the second step estimates.
Costs and benefits are presented in this RIA in the same two steps that
emissions reductions were estimated.  First, the costs associated with
applying known controls were quantified, and presented along with an
estimate of their economic impact.  Second, EPA estimated costs of the
additional tons of extrapolated emission reductions estimated needed to
reach full attainment.  The analysis of the benefits of setting an
alternative standard included both mortality and morbidity calculations
matching the costs of applying known controls and then the benefits of
reaching full attainment.  The costs and monetized benefits were then
compared to provide an estimate of net benefits nationwide.

The RIA presents two sets of results for estimated costs and benefits.
The first reflects full attainment in 2020 in all locations except two
areas of California which are not required to attain the current
standard by 2020.  For the national attainment estimate in 2020 these
two California areas have costs and benefits estimated for where they
should be in 2020 (their “glidepath” target).  The second estimate,
for California only, presents the additional costs and benefits that
might result from California fully attaining the standards in a year
beyond 2020 (glidepath estimate for 2020, plus further increment to full
attainment after 2020, added together for California total).

To streamline this RIA, it refers to several previously published
documents, including two technical documents EPA produced to prepare for
the ozone NAAQS proposal.  The first was a Criteria Document created by
EPA’s Office of Research and Development (published in 2006), which
presented the latest available pertinent information on atmospheric
science, air quality, exposure, dosimetry, health effects, and
environmental effects of ozone.  The second was a “Staff Paper”
(published in 2007) that evaluated the policy implications of the key
studies and scientific information contained in the Criteria Document,
as well as presented a risk assessment for various standard levels.  The
Staff Paper also includes staff conclusions and recommendations to the
Administrator regarding potential revisions to the standards.  In
addition to the Criteria Document and Staff Paper, this ozone RIA relies
heavily on the 2006 RIA for particulate matter (PM).  Many of the models
and methodology used here are the same as in the PM NAAQS RIA.  This RIA
identifies methodologies used to generate data, but refers readers to
the PM NAAQS RIA for many technical details.  The focus of this RIA is
to explain in detail how the approach or methodologies have changed from
the PM NAAQS RIA analysis, and to present the results of the
methodologies employed in this analysis, which compares attainment of
tighter levels of the ozone standard to the baseline of the current
standard.

	Ozone Standard Alternatives Considered

Per Executive Order 12866 and the guidelines of OMB Circular A-4, this
RIA presents analyses of the range of standards proposed by the
Administrator in the Notice of Proposed Rulemaking (0.070 – 0.075
ppm), as well as one more stringent option (0.065 ppm).  The less
stringent option is the baseline, or the current primary standard for
ozone (0.08 parts per million (ppm), calculated as the 3-year average of
the annual fourth-highest daily maximum 8-hour average ozone
concentration measured at each monitor within an area -- effectively
0.084 ppm using current data rounding conventions).

The EPA Administrator received recommendations to revise the current
primary ozone standard from both the Clean Air Act Scientific Advisory
Council (CASAC) and EPA staff.  Both CASAC and staff expressed the view
that the current standard was not adequately protective of human health
and should be tightened to provide additional public health protection.
Specifically, CASAC recommended that “…the current primary ozone
NAAQS [should] be revised and that the level that should be considered
for the revised standard be from 0.060 to 0.070 ppm.”   In the Staff
Paper, EPA staff suggested a slightly broader range, recommending
“that consideration be given to a standard level within the range of
somewhat below 0.080 ppm to 0.060 ppm.”   Both of these
recommendations encourage maintaining the same averaging time and form
as the current standard.  Additionally, both recommendations suggested
it was appropriate to specify the level of the standard out to three
significant digits.

In the concurrent ozone NAAQS proposal, EPA proposes to revise the
8-hour standard to a level within the range of 0.070 to 0.075 ppm to
provide increased protection for children and other sensitive
populations against an array of ozone-related adverse health effects
that range from decreased lung function and increased respiratory
symptoms to serious indicators of respiratory morbidity including
emergency department visits and hospital admissions for respiratory
causes, and possibly cardiovascular-related morbidity as well as total
nonaccidental and cardiopulmonary mortality.  The EPA also proposes to
specify the level of the primary standard to the nearest thousandth ppm.

This RIA presents benefit and cost estimates for both ends of the
proposal range of 0.070 to 0.075 ppm.  It also assesses the costs and
benefits of attaining one more stringent standard option (0.065 ppm).
Since EPA is not considering loosening the standard, the less stringent
option to the proposed range is the current standard itself.  Since this
RIA presents an analysis of the costs and benefits incremental to the
current standard, retaining the current standard would have no
additional incremental costs or benefits.

For the secondary standard, EPA proposes to revise the current 8-hour
standard with one of two options to provide increased protection against
ozone-related adverse impacts on vegetation and forested ecosystems.
One option is to replace the current standard with a cumulative,
seasonal standard expressed as an index (called the W126) of the annual
sum of weighted hourly concentrations, cumulated over 12 hours per day
(8:00 am to 8:00 pm) during the consecutive 3-month period within the
ozone season with the maximum index value, set at a level within the
range of 7 to 21 ppm-hours.  The other option is to make the secondary
standard identical to the proposed primary 8-hour standard in all
respects.  This RIA provides a limited discussion of an alternative
secondary standard showing the number of additional counties with
monitors which may violate the standards depending on the level of the
secondary standard.  Costs and benefits of attaining the different
levels of the secondary were not estimated in this RIA; this analysis
focused on the health benefits of the primary standard.  An analysis of
a separate secondary will be included in the final RIA as appropriate.
Hereafter, any reference to the ozone standard will be assumed to be the
primary standard, unless otherwise noted.

1.5 	References:

Henderson, R. 2006. October 24, 2006.  Letter from CASAC Chairman Rogene
Henderson to EPA Administrator Stephen Johnson, , EPA-CASAC-07-001.

U.S. EPA. 1970. Clean Air Act. 40CFR50.

U.S. EPA. 2006 .Air Quality Criteria for Ozone and Related Photochemical
Oxidants (Final). U.S. Environmental Protection Agency, Washington, DC,
EPA/600/R-05/004aF-cF,

U.S EPA. 2007. Review of the National Ambient Air Quality Standards for
Ozone: Policy Assessment of Scientific and Technical Information. OAQPS
Staff Paper. North Carolina. EPA-452/R-07-003

Pertinent Statutory and Executive Orders

1. Executive Order 12866: Regulatory Planning and Review

  HYPERLINK
"http://www.archives.gov/federal-register/executive-orders/pdf/12866.pdf
"
http://www.archives.gov/federal-register/executive-orders/pdf/12866.pdf

2. Paperwork Reduction Act, 44 U.S.C. 3501 et seq

  HYPERLINK
"http://www.archives.gov/federal-register/laws/paperwork-reduction/"
http://www.archives.gov/federal-register/laws/paperwork-reduction/

3. Regulatory Flexibility Act, 5 U.S.C. 601 et seq.

  HYPERLINK
"http://www.archives.gov/federal-register/laws/regulatory-flexibility/"
http://www.archives.gov/federal-register/laws/regulatory-flexibility/

4. Unfunded Mandates Reform Act, Public Law 104-4

  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=104_cong_publ
ic_laws&docid=f:publ4.104.pdf"
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=104_cong_publi
c_laws&docid=f:publ4.104.pdf

5. Executive Order 13132: Federalism, Executive Order 13132

  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register
&docid=fr10au99-133.pdf"
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register&
docid=fr10au99-133.pdf

6. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments

  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register
&docid=fr09no00-167.pdf"
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&
docid=fr09no00-167.pdf

7.  Executive Order 13045: Protection of Children from Environmental
Health & Safety Risks

  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1997_register
&docid=fr23ap97-130.pdf"
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1997_register&
docid=fr23ap97-130.pdf

8.  Executive Order 13211: Actions that Significantly Affect Energy
Supply, Distribution or Use

  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register
&docid=fr22my01-133.pdf"
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register&
docid=fr22my01-133.pdf

9. National Technology Transfer Advancement Act, Public Law No. 104-113,
§12(d)

  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=104_cong_publ
ic_laws&docid=f:publ113.104.pdf"
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=104_cong_publi
c_laws&docid=f:publ113.104.pdf

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

  HYPERLINK
"http://www.archives.gov/federal-register/executive-orders/pdf/12898.pdf
"
http://www.archives.gov/federal-register/executive-orders/pdf/12898.pdf

 U.S. Office of Management and Budget. Circular A-4, September 17, 2003.
Found on the Internet at <  HYPERLINK
"http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf"
http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf >.

 (Henderson, 2006c, p. 5).  Henderson, R. (2006c) Letter from CASAC
Chairman Rogene Henderson to EPA Administrator Stephen Johnson, October
24, 2006, EPA-CASAC-07-001.

 U.S EPA. 2007. Review of the National Ambient Air Quality Standards for
Ozone: Policy Assessment of Scientific and Technical Information. OAQPS
Staff Paper. North Carolina. EPA-452/R-07-003

 PAGE

 PAGE   7

 PAGE

 PAGE   10

 PAGE

Estimate 2020 Emissions

Model 2020 Baseline Air Quality

Identify Areas Projected to Exceed Alternate Standard and  Calculate
Needed Reduction Targets

Select Control Strategies

Estimate Modeled                    Control Costs

Estimate Economic Impacts

Estimate Modeled Human Health Effects and Dollar Benefits

Determine Post-Control Air Quality and Compare pre- and post-control
strategy air quality

(partial attainment in most areas)

Extrapolate Tons to Reach Full Attainment and Compare pre-and post-
extrapolation air quality

Estimate Extrapolated                  Control Costs

Estimate Extrapolated Human Health Effects and Dollar Benefits


[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Notices]
[Pages 55384-55385]
[FR Doc No: 2018-24188]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4393-DR; Docket ID FEMA-2018-0001]

North Carolina; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the

State of North Carolina (FEMA-4393-DR), dated September 14, 2018, and
related determinations.

DATES: This amendment was issued October 22, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Carolina is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of September 14, 2018.

    Bertie and Davidson Counties for Public Assistance, including
direct federal assistance.
    Pitt County for Public Assistance [Categories C-G] (already
designated for Individual Assistance and assistance for debris
removal and emergency protective measures [Categories A and B],
including direct federal assistance, under the Public Assistance
program).
    Orange County for Public Assistance, including direct federal
assistance (already designated for Individual Assistance).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-24188 Filed 11-2-18; 8:45 am]
 BILLING CODE 9111-11-P


[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Page 27278]
[FR Doc No: 2012-11144]

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DEPARTMENT OF TRANSPORTATION

 National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0050]

National Emergency Medical Services Advisory Council (NEMSAC);
Notice of Federal Advisory Committee Meeting

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

ACTION: Meeting notice--National Emergency Medical Services Advisory
Council.

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

SUMMARY: The NHTSA announces a meeting of NEMSAC to be held in the
Metropolitan Washington, DC area. This notice announces the date, time,
and location of the meeting, which will be open to the public. The
purpose of NEMSAC is to provide a nationally recognized council of
emergency medical services representatives and consumers to provide
advice and recommendations regarding Emergency Medical Services (EMS)
to DOT's NHTSA.

DATES: The meeting will be held on May 30, 2012, from 10 a.m. to 5 p.m.
EDT, and on May 31, 2012, from 8 a.m. to 12 p.m. EDT. A public comment
period will take place on May 30, 2012 between 3:30 p.m. and 4:30 p.m.
EDT. Written comments must be received by May 25, 2012.

ADDRESSES: The meeting will be held on the 8th floor of the FHI 360
Conference Center at 1825 Connecticut Avenue NW., Washington, DC 20009.

FOR FURTHER INFORMATION CONTACT: Drew Dawson, Director, U.S. Department
of Transportation, Office of Emergency Medical Services, 1200 New
Jersey Avenue SE., NTI-140, Washington, DC 20590, telephone number 202-
366-9966; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C.
App.). The NEMSAC will meet on Wednesday and Thursday, May 30-31, 2012,
on the 8th floor of the FHI 360 Conference Center at 1825 Connecticut
Avenue NW., Washington, DC 20009.

Tentative Agenda of National EMS Advisory Council Meeting, May 30-31,
2012

    The tentative agenda includes the following:

Wednesday, May 30, 2012 (10 a.m. to 5 p.m. EDT)

(1) Opening Remarks
(2) Introduction of Members and All in Attendance
(3) Review and Approval of Minutes of Last Meeting
(4) Update From NHTSA Office of EMS
(5) Federal Partner Update
(6) Review of the NEMSAC Roundtable on the EMS Education Agenda for the
Future Meeting Results
(7) Public Comment Period (3:30 p.m. to 4:30 p.m. EDT)
(8) Business of the Council

Thursday, May 31, 2012 (8 a.m. to 12 p.m. EDT)

(1) Presentations from NEMSAC Committees
(2) Deliberations of Committee Documents
(3) Voting To Finalize Several NEMSAC Advisories and Recommendations
(4) Unfinished Business/Continued Discussion From Previous Day
(5) Next Steps and Adjourn

    Public Attendance: This meeting will be open to the public. There
will not be a teleconference option for this meeting. Individuals
wishing to attend must register online at www.regonline.com/NEMSAC1 no
later than May 25, 2012.
    Public Comment: Members of the public who wish to make comments on
Wednesday, May 30, 2012, between 3:30 p.m. and 4:30 p.m. EDT are
requested to register in advance. In order to allow as many people as
possible to speak, speakers are requested to limit their remarks to 5
minutes. Written comments from members of the public will be
distributed to NEMSAC members at the meeting and should reach the NHTSA
Office of EMS by May 25, 2012. All submissions received may be
submitted by either one of the following methods: (1) You may submit
comments by email<EMAIL_ADDRESS>or (2) you may submit comments by
fax:<PHONE_NUMBER>.
    A final agenda as well as meeting materials will be available to
the public online through www.ems.gov prior to May 30, 2012.

    Issued on: May 4, 2012.
Jeffrey P. Michael,
Associate Administrator for Research and Program Development.
[FR Doc. 2012-11144 Filed 5-8-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: January 13, 2006 (Volume 71, Number 9)]
[Notices]
[Page 2210-2211]
[DOCID:fr13ja06-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL06-40-000]

Badger Power Marketing Authority, Inc. and Great Lakes Utilities,
Complainant, v. Wisconsin Public Service Corporation, Respondent;
Notice of Complaint

January 6, 2006.
    Take notice that on December 30, 2005, Badger Power Marketing
Authority (Badger) and Great Lakes Utilities (GLU) filed a Complaint
against Wisconsin Public Service Corporation (WPSC) alleging that WPSC
has treated its affiliate Upper Peninsula Power Corporation
preferentially by granting it contract termination rights and a rate
reduction, while not providing Badger similar relief.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies

of the protest or intervention to the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 19, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-280 Filed 1-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 4, 2009 (Volume 74, Number 212)]
[Notices]
[Page 57163-57164]
[DOCID:fr04no09-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 803-087 ]

Pacific Gas and Electric Company; Notice of Authorization for
Continued Project Operation

October 28, 2009.
    On October 2, 2007, Pacific Gas and Electric Company, licensee for
the DeSabla-Centerville Hydroelectric Project, filed an Application for
a New License pursuant to the Federal Power Act (FPA) and the
Commission's regulations thereunder. The DeSabla-Centerville
Hydroelectric Project is located on the Butte Creek and West Branch
Feather River, in Butte County, CA.
    The license for Project No. 803 was issued for a period ending
October 11, 2009. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 803 is issued to
the Pacific Gas and Electric Company for a period effective October 12,
2009 through October 11, 2010, or until the issuance of a new license
for the project or other disposition under the FPA, whichever comes
first. If issuance of a new license (or other disposition) does not
take place on or before October 11, 2010, notice is hereby given that,
pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1)
of the FPA is renewed

automatically without further order or notice by the Commission, unless
the Commission orders otherwise. If the project is not subject to
section 15 of the FPA, notice is hereby given that the Pacific Gas and
Electric Company is authorized to continue operation of the DeSabla-
Centerville Hydroelectric Project, until such time as the Commission
acts on its application for a subsequent license.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-26471 Filed 11-3-09; 8:45 am]

BILLING CODE 6717-01-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON D.C., 20460

	OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

									DP Barcode: 368735

									PC Code: 108800

										April 22, 2010

MEMORANDUM

SUBJECT: 	Drinking Water Assessment for S-Metolachlor and its Degradates Ethanesulfonic Acid (ESA) and Oxanilic Acid (OA) for Various Crop Uses

TO:		Sidney Jackson, Risk Manager Reviewer

		Barbara Madden, Risk Manager

		Registration Division

FROM:	Christopher M. Koper, Chemist

		Environmental Risk Branch I

		Environmental Fate and Effects Division

THRU:	Anita Pease, Acting Branch Chief

		Brian Anderson, Risk Assessment Process Leader

		James Lin, Secondary Reviewer

		Environmental Risk Branch I

		Environmental Fate and Effects Division

1.	Executive Summary:

1.1.	Assessed Chemicals and Commodities:

This drinking water assessment was conducted for a petition submitted by the Interregional Research Project Number 4 (IR-4) to establish s-metolachlor tolerances for sesame, melon subgroup 9A, bushberry subgroup 13-07B, lowbush blueberry, caneberry subgroup 13-07A, sweet sorghum, leafy brassica greens subgroup 5B, turnip greens, carrot, cucumber, okra, bulb onion subgroup 3-07A and green onion subgroup 3-07B.  S-Metolachlor is a broad spectrum herbicide that acts to inhibit seedling development.  It can be applied to crops as a pre-emergent or post-emergent broadcast ground application as well as a surface band application.  This assessment was based on information contained in the Dual Magnum( (EPA Reg. No. 100-816) label.

This drinking water assessment was conducted on the parent s-metolachlor and its major degradates ethanesulfonic acid (ESA) and oxanilic acid (OA).  It is important to note that the environmental fate data has been bridged from the racemic mixture (50:50) of metolachlor to the newer isomer (88:12) s-metolachlor, based on similarities in environmental fate behavior.

1.2.	Application Rates:

The Estimated Drinking Water Concentrations (EDWCs) for use in the human dietary health risk assessment are based on the maximum new proposed application rate specified in the Dual Magnum( label, which is a single yearly application of 3.81 lbs a.i./acre for use on caneberry.

The application rate for the degradate ESA was calculated by multiplying the application rate of the parent active ingredient by the fraction of the maximum detected degradate from the submitted fate studies (0.12; MRID 43928936) and then multiplying by the ratio of the molecular weights of the degradate to parent (329.1 g/mol /283.8 g/mol).  Following this equation, the maximum single application rate for the ESA degradate is 0.53 lbs a.i./acre for caneberry use.  The application rate for the OA degradate was calculated by multiplying the application rate of the parent active ingredient by the fraction of the maximum detected degradate from the submitted fate studies (0.28; MRID 41309801) and then multiplying by the ratio of the molecular weights of the degradate to parent (279.1 g/mol /283.8 g/mol).  Following this equation, the maximum single application rate for the OA degradate is 1.05 lbs a.i./acre for caneberry use.

S-Metolachlor and its degradates ESA and OA have been detected extensively in surface water and groundwater as reported in the Tolerance Reassessment Document (US EPA, 2002).  Based on the proposed application rates and the environmental fate properties of s-metolachlor, surface water and groundwater contamination may occur from s-metolachlor as well as its degradates ESA and OA.

Modeling Approach:

Tier I and Tier II screening models were employed for this assessment.  For surface water, PRZM/EXAMS (PE5) and FIRST (FQPA Index Reservoir Screening Tool) Version1.1.1 models were used to estimate drinking water concentrations for the parent s-metolachlor and the ESA and OA degradates, respectively.  The SCI-GROW model (Screening Concentration in Ground Water Program Version 2.3) was used to predict the maximum acute and chronic concentrations present in shallow groundwater.

1.4.	Monitoring Data:

Since the previous EDWCs for surface water for the parent s-metolachlor were based on NAWQA monitoring data, a search of the available monitoring data was performed on March 30, 2010 to ensure that the most current monitoring data were considered in this assessment.  The data set captured the timeframe of October 1991 to October 2009 and included the parent s-metolachlor and its degradates ESA and OA.  Based on a review of the current monitoring data, concentrations of parent s-metolachlor and its degradates were less than values reported from the previous monitoring data (US EPA, 2002).  Therefore, EDWCs based on previous monitoring are still valid.

1.5.	Results and EDWC Recommendations:

A summary of recommended surface and groundwater EDWCs for the human dietary risk assessment for the parent s-metolachlor and its degradates ESA and OA are presented in Table 1.   Table 1 contains EDWCs based on this current assessment as well as values reported in the previous drinking water assessment (D324967) dated 20 March 2006.  Values derived from the current modeling exercise are bolded in Table 1.

Table 1. Recommended Drinking Water Concentrations (EDWCs) for Surface Water and Groundwater for Human Dietary Health Risk Assessment

Chemical Identity – Drinking Water Source	Acute

 (µg/L)	Chronic

(µg/L)	Cancer Chronic

(µg/L)

Surface Water

S-Metolachlor (parent) – Surface Water

Crop Use or Monitoring Data	77.60

monitoring data	18.15

CA cole crop	9.15

KS sorghum

Ethanesulfonic Acid (ESA) – Surface Water

Crop Use or Monitoring Data	47.61

caneberry	34.04

caneberry	34.04

caneberry

Oxanilic Acid (OA) – Surface Water

Crop Use or Monitoring Data	93.57

caneberry	66.62

caneberry	66.62

caneberry

Groundwater

S-Metolachlor (parent) – Groundwater

Crop Use or Monitoring Data	32.8

monitoring data	32.8

monitoring data	32.8

monitoring data

Ethanesulfonic Acid (ESA) – Groundwater

Crop Use or Monitoring Data	63.7

monitoring data	63.7

monitoring data	63.7

monitoring data

Oxanilic Acid (OA) – Groundwater

Crop Use or Monitoring Data	29.7

caneberry 	29.7

caneberry	29.7

caneberry

Bold values denote the maximum EDWCs modeled in this assessment that exceed the EDWCs based on monitoring and modeling data reported in the previous drinking water assessment (D324967) dated 20 March 2006.

For surface water, the single chronic value from FIRST is used as the chronic and cancer chronic values.

For groundwater, the single output value from SCI-GROW is used as the acute, chronic and cancer chronic values.

2.	Environmental Fate and Transport Summary:

The information from all acceptable and upgradable environmental fate data indicate that parent metolachlor/s-metolachlor appears to be moderately persistent to persistent.  It is mobile to highly mobile in different soils and has been detected extensively in surface water and groundwater.  Metolachlor/s-metolachlor degradation appears to be dependent on microbially mediated (aerobic soil metabolism t1/2 = 66 days, 37.8 days, 37.8 days, 14.9 days, 13.9 days, and 50.3 days, anaerobic soil metabolism t1/2 =81 days) and abiotic processes (photodegradation in water t1/2  = 70 days under natural sunlight and photodegradation on soil t1/2 = 8 days under natural sunlight).

The major degradates were identified as CGA-51202 (metolachlor OA), CGA-50720, CGA-41638, CGA-37735, and CGA-13656.  Subsequent studies identified CGA-354743 (metolachlor ESA) as a major degradate (of these major degradates, metolachlor ESA and metolachlor OA have been identified in both groundwater and surface water).  Depending on the soil (i.e. organic matter content), metolachlor/s-metolachlor has the potential to range from a moderately mobile to a highly mobile material with Kd values ranging from 0.11 to 44.8 mL g/oc, and Koc values ranging from 21.6 to 367 L/kg oc.

EFED concluded there is no difference in soil sorption affinity between metolachlor and s-metolachlor.  There was no statistical difference between Koc values in non-paired batch equilibrium studies; similar Koc coefficients for metolachlor (mean Koc=249.250) and s-metolachlor (mean Koc=265.875) were observed in paired batch equilibrium studies.  These data suggest that metolachlor and s-metolachlor are expected to be highly mobile to mobile in soil and water environments.  A more detailed summary of the fate data are presented in Appendix A.

Field dissipation studies indicate that metolachlor/s-metolachlor is persistent in surface soil with half lives ranging from 7 to 292 days in the upper six inch soil layer depending on geographic location.  Metolachlor/s-metolachlor was reportedly detected as deep as the 36 to 48 inch soil layer in some of the studies.  Metolachlor OA (CGA-51202), was detected (0.11 ppm) as deep as the 30-36 inch soil depth (MRID No. 41335701); CGA-40172 was detected as deep as the 36-48 inch depth (MRID No. 41309802); CGA-40919 was detected in the 36-48 inch depth (0.21 ppm in MRID No. 41309802); and CGA-50720 was not detected (LOD = 0.07 ppm) in any soil segment at any interval.

3.	Water Resources Summary:

3.1.	Monitoring:

S-Metolachlor and its degradates ESA and OA have been detected extensively in surface water and groundwater.  A more detailed summary of the monitoring data can be found in the Tolerance Reassessment Document (US EPA, 2002).  Since the previous EDWCs for surface water for the parent s-metolachlor were based on NAWQA monitoring data, a search of the available monitoring data was performed on March 30, 2010 to ensure that the most current monitoring data were considered in this assessment.  The data set captured the timeframe of October 1991 to October 2009 and included the parent s-metolachlor and its degradates ESA and OA.  Based on a review of the current monitoring data, concentrations of parent s-metolachlor and its degradates were less than values reported from the previous monitoring data (US EPA, 2002).  Therefore, EDWCs based on previous monitoring are still valid.  However, some of the previously reported EDWCs, which were based on monitoring data, were exceeded based on modeled concentrations derived from the proposed uses in this assessment.

3.2.	Drinking Water Exposure Modeling:

EDWCs were generated using EFED’s standard suite of models.  The proposed uses from the provided label were assessed.  Two specialty scenarios, OR Berry OP and CA Cole Crop RLF were used to characterize caneberry and leafy Brassica and turnip greens, respectively.

The Pesticide Root Zone Model (PRZM v3.12.2, May 12, 2005) and Exposure Analysis Modeling System (EXAMS v<IP_ADDRESS>, April 25, 2005) are simulation models coupled with the input PE5.pl shell (PE5, PE Version 5.0, November 15, 2006) was used to generate EDWCs of the parent s-metolachlor that may occur in surface water used as drinking water.  The PRZM model simulates pesticide movement and transformation on and across the agricultural field resulting from crop applications.  The EXAMS model simulates pesticide loading via runoff, erosion, and spray drift assuming a standard watershed of 172.8 ha that drains into an adjacent standard drinking water index reservoir of 5.26 ha, an average depth of 2.74 m.  A more detailed description of the index reservoir watershed can be found in Jones et al., 1998.  The coupled PRZM/EXAMS model and users manuals may be downloaded from the U.S. Environmental Protection Agency (EPA) Water Models web-page (USEPA, 2006).  Percent Crop Areas (PCA) that account for the maximum area within a watershed that may be planted with the modeled crop are applied to concentrations predicted by PRZM/EXAMS.

In addition, the standard FL carrot scenario is based on a sandy soil, although carrots in FL are oftentimes grown in muck soils.  In order to characterize the potential impact on EDWCs based on FL carrots grown in muck soils, the organic carbon and bulk density parameters from the first soil horizon were modified from the standard carrot scenario.  The percent organic carbon content of 1.16% was changed to 12.00% (Brady, 1990) and the bulk density was changed from 1.65 g/m3 to 1.50 g/m3 to reflect muck characteristics of the soil.  The acute, chronic and cancer chronic EDWCs were 52.57 µg/L, 7.75 µg/L, and 4.99 µg/L, respectively.  In general, EDWCs values generated using the muck soil scenario are lower than those derived based on the standard sandy soil FL carrot scenario.  These values are used to characterize EDWCs associated with carrots grown in muck soils and are further discussed as uncertainty in this assessment.

The FIRST (FQPA Index Reservoir Screening Tool) model is a Tier I model used to estimate both acute and chronic pesticide concentrations in untreated drinking water.  The FIRST model was employed to derive EDWCs for the ESA and OA degradates only.

The SCI-GROW model (v2.3, Jul. 29, 2003) is a regression-based screening tool used to estimate pesticide concentrations found in ground water used as drinking water.  SCI-GROW was developed by fitting a linear model to ground water concentrations with the Relative Index of Leaching Potential (RILP) as the independent variable.  Groundwater concentrations were taken from 90-day average high concentrations from Prospective Ground Water studies.  The RILP is a function of aerobic soil metabolism and the soil-water partition coefficient.  The output of SCI-GROW represents the concentrations of residues that might be expected in shallow unconfined aquifers under sandy soils, which are representative of the ground water most vulnerable to pesticide contamination and likely to serve as a drinking water source.  The SCI-GROW model and User’s Manual may also be downloaded from the EPA Water Models web-page   HYPERLINK "http://epa.gov/oppefed1/models/water/"  http://epa.gov/oppefed1/models/water/  (USEPA, 2006).

3.3.	Surface Water Model Inputs:

Due to the stability and mobility of the parent s-metolachlor, the compound may move from the treated field to surface water through run-off which occurs shortly after application (i.e. rainfall events).  Because limited data are available on the fate characteristics of the degradates ESA and OA, the aerobic soil metabolism rate constant was conservatively estimated using the Comparative Aerobic Soil Metabolism Study (MRID 43928936) submitted to support bridging of fate data from the racemic to the s-isomer of metolachlor.  Aerobic soil metabolism half-lives were estimated using only the decline portion of the data for each degradate.  Half-lives for other parameters (i.e. aerobic aquatic metabolism, hydrolysis, photolysis) where no data were available were conservatively assumed to be stable as per EFED guidance.  An adsorption/desorption study (MRID 40494605) was previously submitted for metolachlor OA.  The lowest non-sand Kd value (0.079 mL g/oc for Maryland clay) was selected for surface water degradate modeling, and the lowest Koc measured for all available soil types (2.82 L/kg oc for the Maryland clay) was used for groundwater modeling.   An adsorption/desorption study (MRID 44931722) was previously submitted for metolachlor ESA and is currently under review.  The lowest non-sand Kd value (0.041 mL g/oc for Maryland clay) was selected for surface water degradate modeling, and the lowest Koc (2.01 L/kg oc for the Maryland sandy loam) was used for groundwater modeling.

The drinking water concentrations derived from surface water for the parent s-metolachlor and its degradates (ESA and OA) were estimated using PRZM/EXAMS and FIRST models, respectivley.  Input paremeters for s-metalachlor, ESA, and OA are reported in Tables 2, 3, and 4, respectively.  Model outputs are included in Appendix B.

Table 2.  PRZM/EXAMS Input Parameters for S-Metolachlor (Parent).

Input Parameter:	Value:	Comment:	Source:

Scenario(s):	Sesame:  KS Sorghum

Melon:  MI, MO, NJ Melons

Bushberry:  OR Berries

Caneberry:  OR Berries

Sorghum:  KS Sorghum

Leafy (Brassica), Turnip Greens: CA Cole Crop

Carrot:  FL Carrot

Cucumber:  FL Cucumber

Okra:  CA, FL, PA Tomato

Dry Bulb Onions:  CA, GA Onions

Green Onions:  CA, GA Onions	representative scenarios for each use	N/A

Maximum Single

Application Rate

lbs a.i./A (kg a.i./ha)	Sesame:  1.90  (2.13)

Melon:  1.21  (1.36)

Bushberry: 1.27  (1.43)

Caneberry:  3.81  (4.28)

Sorghum:  1.67  (1.88)

Leafy (Brassica), Turnip Greens:  1.27  (1.43)

Carrot (mineral soil):  1.27  (1.43)

Carrot (muck soil):  1.90  (2.13)

Cucumber:  1.27  (1.43)

Okra:  1.90  (2.13)

Dry Bulb Onions:  1.27  (1.43)

Green Onions:  1.27  (1.43)	proposed rates	proposed  label

Applications per Year	Sesame:  1

Melon:  1

Bushberry: 1

Caneberry:  1

Sorghum:  1

Leafy (Brassica), Turnip Greens:  1

Carrot:  1

Cucumber:  1

Okra:  1

Dry Bulb Onions:  2

Green Onions:  1	label directions.  Label specifies rates per season.  If crops are rotated with those on which s-metolachlor is used, yearly rates may be higher.	proposed label

Application Interval (days)	Sesame:  N/A

Melon:  N/A

Bushberry: N/A

Caneberry:  N/A

Sorghum:  N/A

Leafy (Brassica), Turnip Greens:  N/A

Carrot:  N/A

Cucumber:  N/A

Okra:  N/A

Dry Bulb Onions:  21

Green Onions:  N/A	intervals were selected to reflect labeled application patterns.	proposed label

Date of Initial Application

(scenario/day/month)	Sesame:

KS Sorghum:  13-05

Melon:

MI Melon:  23-04

MO Melon:  03-04

NJ Melon:  24-04

Bushberry:

OR Berry:  Highbush:  25-03

OR Berry:  Lowbush:  08-04

Caneberry:

OR Berry:  25-03

Sorghum:

KS Sorghum:  13-05

Leafy (Brassica), Turnip Greens:

CA Cole Crop:  25-12

Carrot:

FL Carrot:  09-10

Cucumber:

FL Cucumber:  09-10

Okra:

CA Tomato:  08-03

FL Tomato:  08-02

PA Tomato:  23-04

Dry Bulb Onions:

CA Onion:  23-01

GA Onion:  22-09

Green Onions:

CA Onion:  23-01

GA Onion:  22-09	7 days before crop emergence was selected for pre-emergent applications.

7 days after crop emergence was selected for post-emergent applications.

Label directions were followed for ground surface band applications.

	Crop Scenarios

Application Method	Foliar Ground: for pre- and post-emergent applications

Ground: for Surface Band Applications	label directions	proposed label

CAM Input	2

1	foliar – ground

ground - surface band	proposed label

IPSCND Input	3

N/A	remaining pesticide on foliage is retained as surface residue and continues to undergo decay.

ground – surface band	US EPA, 2005

Spray Drift Fraction	0.064

0	foliar - ground

ground – surface band	Input parameter guidance (USEPA, 2009)

Application Efficiency	0.99

1.00	foliar - ground

ground – surface band	Input parameter guidance

(USEPA, 2009)

Molecular Mass (g/mol)	283.8	product chemistry data	US EPA, 2002 TRED

Vapor Pressure at 25°C (torr)	2.8 x 10-5	product chemistry data	US EPA, 2002 TRED

Henry’s Law Constant

(atm-m3/mol)	2.2 x 10-8	calculated from volatility and solubility data registrant submitted data

Solubility in Water at 25oC (mg/L)	480	product chemistry data	US EPA, 2002 TRED

Organic Carbon Partition Coefficient (Koc) (L/kg oc)	181	represents the average KOC	represents the average value from all non-paired adsorption data

Aerobic Soil Metabolism Half-life (days)	48.9	represents the upper 90th percentile based on linear regression of all aerobic soil metabolism data for racemic and s-metolachlor	US EPA, 2002 TRED

Aerobic Aquatic Metabolism Half-life (days)	141	based on three times the single aerobic aquatic metabolism linear first order half-life	MRID 41185701

Anaerobic Aquatic Metabolism Half-life (days)	234	based on three times the single anaerobic aquatic metabolism linear first order half-life MRID 41185701

Hydrolysis Half-lives (days)	0  (stable)	no data available; assume stable as conservative assumption	US EPA, 2002 TRED

Aqueous Photolysis

Half-life (days)	70

US EPA, 2002 TRED

-N/A = Not Applicable

Table 3:  FIRST Input Parameters for the S-Metolachlor Degradate Ethanesulfonic Acid (ESA) for Caneberry Use

Parameter:

Input Value:

Data Source/Rationale: 1

Application Rate (lbs a.i./acre)

0.53 2

EPA Reg. No. 100-816

Maximum Number of Applications/Year

1

EPA Reg. No. 100-816

Application Interval (days)

NA

EPA Reg. No. 100-816

Percent Crop Area (as decimal)

0.87

National Default Value

Kd (mL/g oc)

0.041

MRID 44931722  (lowest non-sand value)

Aerobic Soil Metabolism Half-life (days)

162.5

MRID 43928936 (upper 90th percentile of linear first order half-lives derived from decline portion of racemic (150.6 days) and s-isomer (156.4 days) from paired aerobic soil metabolism data.

Is the pesticide wetted-in?

No

Chemical not known to be activated by water

Method of Application

D

Granular Application 3

Incorporation Depth (inches)

0

Broadcast Application

Water Solubility (ppm)

480

Product Chemistry Data (assumed to be equivalent to parent)

Aerobic Aquatic Metabolism Half-life (days)

0 (stable)

No data is available; entered zero for conservative assumption as suggested by FIRST users manual

Hydrolysis (pH 7) Half-life (days)

0 (stable)

No data is available; entered zero for conservative assumption as suggested by FIRST users manual

Photolysis Half-life (days)

0 (stable)

No data is available; entered zero for conservative assumption as suggested by FIRST users manual

1  Input Parameters were selected in accordance with the Guidance for Selecting Input Parameters  Version 2.1

   dated October 22, 2009

2  Application Rate of Degradate = (max. application rate of parent) x (fraction of maximum detected degradate) x

  (molecular weight of degradate/ molecular weight of parent)

    Caneberry = (3.81 lbs. a.i./acre) x (0.12) x (329.1/283.8) = 0.53 lbs. a.i./acre

3  Granular method of application was selected for the degradate (Drift = 0.0% and App. Efficiency = 100%).

NA = Not Applicable

Table 4:  FIRST Input Parameters for the S-Metolachlor Degradate Oxanilic Acid (OA) for Caneberry Use

Parameter:

Input Value:

Data Source/Rationale: 1

Application Rate (lbs a.i./acre)

1.05 2

EPA Reg. No. 100-816

Maximum Number of Applications/Year

1

EPA Reg. No. 100-816

Application Interval (days)

NA

EPA Reg. No. 100-816

Percent Crop Area (as decimal)

0.87

National Default Value

Kd (mL/g oc)

0.079

MRID 40494605  (lowest non-sand value)

Aerobic Soil Metabolism Half-life (days)

127.5

MRID 43928936 (upper 90th percentile of linear first order half-lives derived from decline portion of racemic (82.9 days) and s-isomer (104.8 days) from paired aerobic soil metabolism data.

Is the pesticide wetted-in?

No

Chemical not known to be activated by water

Method of Application

D

Granular Application 3

Incorporation Depth (inches)

0

Broadcast Application

Water Solubility (ppm)

480

Product Chemistry Data (assumed to be equivalent to parent)

Aerobic Aquatic Metabolism Half-life (days)

0 (stable)

No data is available; entered zero for conservative assumption as suggested by FIRST users manual

Hydrolysis (pH 7) Half-life (days)

0 (stable)

No data is available; entered zero for conservative assumption as suggested by FIRST users manual

Photolysis Half-life (days)

0 (stable)

No data is available; entered zero for conservative assumption as suggested by FIRST users manual

1  Input Parameters were selected in accordance with the Guidance for Selecting Input Parameters  Version 2.1

   dated October 22, 2009

2  Application Rate of Degradate = (max. application rate of parent) x (fraction of maximum detected degradate) x

  (molecular weight of degradate/ molecular weight of parent)

    Caneberry = (3.81 lbs. a.i./acre) x (0.28) x (279.1/283.8) = 1.05 lbs. a.i./acre

3  Granular method of application was selected for the degradate (Drift = 0.0% and App. Efficiency = 100%).

NA = Not Applicable

3.4.	Groundwater Modeling Inputs:

Due to the stability and mobility of the parent s-metolachlor, the compound may move from the treated field to groundwater through leaching.

The drinking water concentrations derived from groundwater for the parent s-metolachlor and its degradates ESA and OA were estimated using the SCI-GROW model.  Input paremeters for s-metalachlor, ESA, and OA are reported in Tables 5, 6, and 7, respectively.  Model outputs are included in Appendix B.

Table 5.  SCI-GROW Input Parameters for S-Metolachlor for Caneberry Use

Input Parameter	Value	Comment	Source

Maximum Application Rate per growing season (lbs a.i./A)	3.81	maximum application rate representing caneberry	proposed label

Applications per Year	1	label directions	proposed label

 Organic Carbon Partition Coefficient (Koc) (L/kg oc)	21.6	lowest Koc value since there was a greater than three-fold difference within data set from non-paired adsorption data	US EPA, 2002 TRED

Aerobic Soil Metabolism

Half-life (days)	37.8	represents the median half-life value of all aerobic soil metabolism data for racemic and s-metolachlor since more than 4 half-lives are available.  	US EPA, 2002 TRED

Table 6.  SCI-GROW Input Parameters for the S-Metolachlor Degradate Ethanesulfonic Acid (ESA) for Caneberry Use

Input Parameter	Value	Comment	Source

Maximum Application Rate per growing season (lbs a.i./A)	0.53 1   assumes 12% conversion of parent to degradate from the aerobic soil metabolism (MRID 43928936) study; application rate adjusted to parent equivalents using molecular weight	proposed label

Applications per Year	1	label directions	proposed label

 Organic Carbon Partition Coefficient (Koc) (L/kg oc)	2.01	lowest Koc value since there was a greater than three-fold difference within data set from non-paired adsorption data (MRID 44931722)	US EPA, 2002 TRED

Aerobic Soil Metabolism

Half-life (days)	153.5	represents the median half-life value of all aerobic soil metabolism data (MRID 43928936) for racemic and s-metolachlor since more than 4 half-lives are available.  	US EPA, 2002 TRED

1  Application Rate of Degradate = (max. application rate of parent) x (fraction of maximum detected degradate) x

  (molecular weight of degradate/ molecular weight of parent)

    Caneberry = (3.81 lbs. a.i./acre) x (0.12) x (329.1/283.8) = 0.53 lbs. a.i./acre

Table 7.  SCI-GROW Input Parameters for the S-Metolachlor Degradate Oxanilic Acid (OA) for Caneberry Use

Input Parameter	Value	Comment	Source

Maximum Application Rate per growing season (lbs a.i./A)	1.05 1   assumes 28% conversion of parent to degradate from the aerobic soil metabolism (MRID 41309801) study; application rate adjusted to parent equivalents using molecular weight	proposed label

Applications per Year	1	label directions	proposed label

 Organic Carbon Partition Coefficient (Koc) (L/kg oc)	2.82	lowest Koc value since there was a greater than three-fold difference within data set from non-paired adsorption data (MRID 40494605)	US EPA, 2002 TRED

Aerobic Soil Metabolism

Half-life (days)	93.8	represents the median half-life value of all aerobic soil metabolism data (MRID 43928936) for racemic and s-metolachlor since more than 4 half-lives are available.  	US EPA, 2002 TRED

1  Application Rate of Degradate = (max. application rate of parent) x (fraction of maximum detected degradate) x

  (molecular weight of degradate/ molecular weight of parent)

    Caneberry = (3.81 lbs. a.i./acre) x (0.28) x (279.1/283.8) = 1.05 lbs. a.i./acre

3.5.	Modeling Results:

For this assessment, the surface and groundwater EDWCs for the parent s-metolachlor and its degradates ESA and OA are presented in Tables 8, 9, and 10, respectively.  For drinking water derived from surface water for the parent s-metolachlor, the maximum reported acute concentration of 71.33 µg/L for the Florida carrot (mineral soil) scenario does not exceed the previous EDWC of 77.6 µg/L from the monitoring data reported in the previous drinking water assessment (D324967) dated 20 March 2006.  However, the maximum annual mean (chronic) concentration of 18.15 µg/L from the California Cole Crop scenario and the maximum 30 year annual average concentration of 9.15 µg/L from the Kansas Sorghum scenario exceed the previous reported EDWC of 4.3 µg/L from the monitoring data reported in the previous drinking water assessment.  For the degradate ESA, the FIRST model’s acute and chronic (annual average) concentrations of 47.61 µg/L and 34.04 µg/L, respectively, exceed the previously reported EDWCs of 31.9 µg/L and 22.8 µg/L from the modeling data reported in the previous drinking water assessment.  For the degradate OA, the FIRST model’s acute and chronic (annual average) concentrations of 93.57 µg/L and 66.62 µg/L, respectively, exceed the previously reported EDWCs of 91.4 µg/L and 65.1 µg/L from the modeling data reported in the previous drinking water assessment.

For drinking water derived from groundwater for the parent s-metolachlor, the SCI-GROW model’s acute and chronic concentration of 5.26 µg/L does not exceed the previously reported EDWC of 32.8µg/L from the monitoring data reported in the previous drinking water assessment.  For the degradate ESA, the SCI-GROW model’s acute and chronic concentration of 45.9 µg/L does not exceed the previously reported EDWC of 63.7µg/L from the monitoring data reported in the previous drinking water assessment.  However, for the degradate OA, the SCI-GROW model’s acute and chronic concentration of 29.7 µg/L does exceed the previously reported EDWC of 13.4µg/L from the monitoring data reported in the previous drinking water assessment.

Table 8. Estimated Drinking Water Concentrations (EDWCs) resulting from applications of S-Metolachlor.

Drinking Water Source (model)	Use Scenario

(modeled rate)	1-in-10 year acute (µg/L)	1-in-10 year chronic (µg/L) 30- year average (µg/L)

Surface Water (PRZM/EXAMS)	(Previous EDWCs for Surface Water)	(77.6) (4.3)	(4.3)

	Sesame:

KS Sorghum – pre-emergence

KS Sorghum – ground surface band

(1 app. @ 1.90 lbs ai/acre)

57.77

54.23

16.08

15.07

9.15

8.07

	Melon:

MI Melon - pre-emergence

MI Melon – ground surface band

MO Melon - pre-emergence

MO Melon – ground surface band

NJ Melon - pre-emergence

NJ Melon – ground surface band

(1 app. @ 1.21 lbs ai/acre)

20.71

18.14

49.59

47.28

25.02

22.41

7.29

6.37

9.39

8.95

7.33

6.53

3.73

2.38

3.59

3.11

3.38

2.53

	Bushberry:

OR Berries – post-emergence

OR Berries – ground surface band

(1 app. @ 1.27 lbs ai/acre)

7.72

12.07

3.02

6.04

1.98

2.00

	Caneberry:

OR Berries – ground surface band

(1 app. @ 3.81 lbs ai/acre)

51.10

18.07

6.00

	Sorghum:

KS Sorghum - pre-emergence

(1 app. @ 1.67 lbs ai/acre)

50.98

14.19

8.08

	Leafy (Brassica), Turnip Greens:

CA Cole Crop - pre-emergence

(1 app. @ 1.27 lbs ai/acre)

41.46

18.15

8.63

	Carrot:

FL Carrot (mineral soil) - pre-emergence

(1 app. @ 1.27 lbs ai/acre)

71.33

9.96

5.59

	Cucumber:

FL Cucumber - pre-emergence

(1 app. @ 1.27 lbs ai/acre)

73.64

9.71

5.57

	Okra:

CA Tomato - post-emergence

CA Tomato – ground surface band

FL Tomato - post-emergence

FL Tomato – ground surface band

PA Tomato - post-emergence

PA Tomato – ground surface band

 (1 app. @ 1.90 lbs ai/acre)

16.83

11.05

52.51

48.35

28.56

24.13

7.61

4.85

7.13

6.38

9.26

7.62

4.80

2.28

3.52

2.92

4.69

3.22

	Dry Bulb Onions:

CA Onion - post-emergence

CA Onion – ground surface band

GA Onion - post-emergence

GA Onion – ground surface band

(2 app. @ 1.27 lbs ai/acre

Application Interval = 21 days)

21.90

14.80

70.41

67.10

10.45

6.75

13.03

11.81

5.32

1.82

5.81

4.69

	Green Onions:

CA Onion - post-emergence

CA Onion – ground surface band

GA Onion - post-emergence

GA Onion – ground surface band

 (1 app. @ 1.27 lbs ai/acre

10.27

6.59

42.17

39.76

5.16

3.18

6.12

5.61

2.90

1.11

3.25

2.73

Groundwater

(SCI-GROW)	(Previous EDWCs for Groundwater)

Caneberry:

(1 app. @ 3.81 lbs a.i./acre)

	(32.8)

5.26	(32.8)

5.26	(32.8)

5.26

Bold text denotes maximum estimated EDWC values from the proposed uses.

PRZM/EXAMS values adjusted with PCA factor of 0.87.

Table 9. Estimated Drinking Water Concentrations (EDWCs) resulting from applications of S-Metolachlor Degradate Ethanesulfonic Acid (ESA) for Caneberry Use.

Drinking Water Source (model)	Use Scenario

(modeled rate)	Peak Day

Acute (µg/L)	Annual Average

Chronic (µg/L)

Surface Water (FIRST)	(Previous EDWCs for Surface Water)

Caneberry:

 (1 app. @ 0.531 lbs ai/acre)	(31.9)

47.61	(22.8)

34.04

Groundwater

(SCI-GROW)	(Previous EDWCs for Groundwater)

Caneberry:

(1 app. @ 0.53 lbs a.i./acre)	(63.7)

45.9	(63.7)

45.9

1 = Application Rate of Degradate = (max. application rate of parent) x (fraction of maximum detected degradate) x

  (molecular weight of degradate/ molecular weight of parent)

    Caneberry = (3.81 lbs. a.i./acre) x (0.12) x (329.1/283.8) = 0.53 lbs. a.i./acre

Note:  FIRST program automatically adjusts EDWC value with PCA factor of 0.87.

Table 10. Estimated Drinking Water Concentrations (EDWCs) resulting from applications of S-Metolachlor Degradate Oxanillic Acid (OA) for Caneberry Use.

Drinking Water Source (model)	Use Scenario

(modeled rate)	Peak Day

Acute (µg/L)	Annual Average

Chronic (µg/L)

Surface Water (FIRST)	(Previous EDWCs for Surface Water)

Caneberry:

 (1 app. @ 1.051 lbs ai/acre)	(91.4)

93.57	(65.1)

66.62

Groundwater

(SCI-GROW)	(Previous EDWCs for Groundwater)

Caneberry:

(1 app. @ 1.05 lbs a.i./acre)

	(13.4)

29.7	(13.4)

29.7

1 = Application Rate of Degradate = (max. application rate of parent) x (fraction of maximum detected degradate) x

  (molecular weight of degradate/ molecular weight of parent)

    Caneberry = (3.81 lbs. a.i./acre) x (0.28) x (279.1/283.8) = 1.05 lbs. a.i./acre

Note:  FIRST program automatically adjusts EDWC value with PCA factor of 0.87.

Uncertainties:

In order to characterize EDWCs for carrots grown in muck soils, the organic carbon and bulk density parameters from the first soil horizon were modified from the standard carrot scenario.  Based on these modifications, the predicted acute, chronic, and cancer chronic EDWCs for FL carrots grown in muck soils are 52.57 µg/L, 7.75 µg/L, and 4.99 µg/L, respectively.  Predicted EDWCs for FL carrots grown in muck soils are generally lower that EDWCs based on the standard sandy soil scenario.  EDWCs are presented for comparative purposes only and are not included in Table 8 of the risk assessment.  Therefore, it is possible that FL carrot EDWCs presented in Table 8 may overestimate exposure for carrots grown in muck scenarios.

References:

Brady N.C. 1990. The Nature and Properties of Soils. 10th Edition.

MacMillan Publishing Company, NY.

Jones, R. D., S. Abel, W. R. Effland, R. Matzner, R. Parker.  1998.  An Index Reservoir for Use

in Assessing Drinking Water Exposure.  Proposed Methods for Basin-scale Estimation of Pesticide Concentrations in Flowing Water and Reservoirs for Tolerance Reassessment.  Presentation to FIFRA Science Advisory Panel, June 29-30, 1998.  Online at:   HYPERLINK "http://www.epa.gov/scipoly/sap/1998/index.htm"  http://www.epa.gov/scipoly/sap/1998/index.htm

US EPA.  2002.  Revised Metolachlor/S-Metolachlor Tolerance Reassessment Document

	(TRED), D248805, D228814, D258817, D258824, D258822, D258812, D259119,

	D259037, D259034).

US EPA.  2005.  PRZM-3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Soil Zones:  Users Manual for Release 3.0.  May 2005.

US EPA.  2009.  Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version 2.1.  U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division, October 22, 2009.

US EPA.  2010.  Water Models.  U.S. Environmental Protection Agency, Pesticides: Science and Policy.  Last updated: November 25, 2009.  Online at:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/

Appendix A:  Environmental Fate Assessment (from the 1994 RED)

Metolachlor appears to be stable to hydrolysis at pH’s of 5, 7, and 9 without significant degradation of parent material after 30 days.

The aqueous photolysis half-life was 70 days when exposed to natural sunlight and 0.17 day when exposed to artificial sunlight (450 watt mercury arc lamp with light intensity of 4500-4800 uW/cm2).  After 30 days exposure to natural sunlight the degradation products were CGA-41638 (3.63% of applied radiocarbon), CGA-51202 (3.54%), CGA-46129 (3.42%), CGA-50720 (3.20%), and parent metolachlor remaining was 62.92%.

The soil photolysis half-life of metolachlor when exposed to natural sunlight was 8 days, and when exposed to artificial  light conditions (mercury arc lamp with intensity of 1600-2400 uW/cm2) the half-life was 37 days.  The major degradates reported after 21 days exposure to natural sunlight were CGA-51202 (maximum of 3.4% of applied radiocarbon), CGA-37735 (9.0%), CGA-41638 (5.7%), and CGA-37913 (7.3%).

Under aerobic soil conditions metolachlor degraded with a half-life of 67 days in a sandy loam soil.  The major metabolite was CGA-51202 (maximum of 28.09% of applied radioactivity at 90 days posttreatment).  Other identified metabolites were CGA-37735 (maximum of 14.85% at 272 days), CGA-41638 (maximum of 2.06% at 90 days), and CGA-13656 (maximum of 1.02% immediately posttreatment).  Other metabolites were detected but not quantified were CGA-40172, CGA-41507, CGA-40919, and CGA-37913.

The aerobic aquatic metabolism half-life of metolachlor was 47 days.  The major metabolites in the sediment were CGA-41507 (3.34% of applied radiocarbon at 29 days), CGA-50720 (1.17%), CGA-40172 (1.13%), CGA-46127 (1.54%), and parent metolachlor was 34.56%.  In the water fraction after 29 days incubation parent metolachlor was 30.90% and the metabolite CGA-41507 was 1.21% and CGA-51202 was 1.9(%.

Under anaerobic soil conditions metolachlor degraded with a half-life of 81 days in a sandy loam soil that was incubated under anaerobic conditions for 60 days at 25oC following 30 days of aerobic incubation.  The major degradate in both the soil and flood water was CGA-51202 (maximum of 23.33% of applied radiocarbon at 29 days after anaerobic conditions were established); and other reported degradates were CGA-37735 (1.25% at 29 days), CGA-41638 (8.3% at 60 days), CGA-13656 (1.46% at 29 days), and CGA-50720 (maximum of 7.34% at 60 days).

The anaerobic aquatic metabolism half-life for metolachlor was 78 days.  In the anaerobic waters the major degradates were CGA-40172 (maximum of 5.64% at 12 months), CGA-37913 (maximum of 4.28% at 6 months), CGA-46127 (maximum of 4.69% at 12 months) and CGA-41507 (maximum of 4.85% at 6 months).  The major degradates in sediment were CGA-41507 (maximum of 15.88% of applied radiocarbon at 12 months), CGA-40172 (maximum of 3.18% at 12 months), CGA-46127 (maximum of 13.02% at 12 months), CGA-50720 (maximum of 1.67% at 29 days), and CGA-37913 (maximum of 2.33% at 6 months), and after 12 months the sediment contained 1.47% parent metolachlor.

In the unaged portion of the leaching and adsorption and desorption study metolachlor was shown to range from being highly mobile in a sand soil (kd value of 0.08) to being moderately mobile (Kd value of 4.81 in a sandy loam) from column leaching studies using four soils.  The leachate contained from 15.03% to 82.91% (comprised of 75.5% parent metolachlor, 1.14% of CGA-51202, 3.69% of CGA-37735, and 2.26% CGA-41638) of the applied radioactivity.  In batch equilibrium studies employing the same four soils, the Freundlich adsorption (Kad) values ranged from 0.108 to 2.157.  These data indicate that metolachlor has the potential to range from being moderately mobile material (clay soil and sandy loam soil) to being a highly mobile material (loam soil and sand soil).

In the aged leaching portion of the leaching and adsorption and desorption study the reported cumulated Kd for aged metolachlor and its degradates in columns of an Iowa sandy loam soil was 2.01.  This indicates that metolachlor and its identified degradates (CGA-51202, CGA-37735, and CGA-41638) have the potential to be mobile since in other studies it was shown that metolachlor and its CGA-51202 degradate leached the slowest in the Iowa sandy loam soil compared to their leaching rate in the other three soils tested.  Batch equilibrium studies showed that CGA-51202 has the potential to be extremely mobile with reported Freundlich adsorption (Kad) values ranging from 0.04 in the Maryland sand to 0.171 in the Iowa sandy loam soil.

Laboratory volatility studies indicated that volatility is not a significant mode of dissipation for metolachlor from soil.  The maximum dissipation was 0.05% of the metolachlor dose volatilizing per day.

In numerous terrestrial field dissipation studies using metolachlor (Dual 8E and Dual 25G) both applied at 4 and 6 lb ai/A the half life of metolachlor in the 6-12 inch soil layer ranged from 7 days (Iowa) to 292 days (California) with a range of the total water applied ranging from 16.97 inches to > 40 inches during the study period.  Detections of metolachlor were made as far as the 36-48 inch soil layer in some of the tests.  The degradate CGA-40172 (0.07 ppm) and CGA-40919 (0.21 ppm) were detected in the 36-48 inch soil layers in one Iowa site.  CGA-50720 was not detected (0.07 ppm) in any soil sampled at any interval.

Metolachlor appears to have a low potential to bioaccumulate in fish with a reported whole body bioconcentration factor of 69X and a whole body elimination of 93% after 14 days depuration.Appendix B: Modeling Outputs

PRZM/EXAMS Outputs:

SCI-GROW Output:  S-Metolachlor Parent

SCIGROW

VERSION 2.3

ENVIRONMENTAL FATE AND EFFECTS DIVISION

OFFICE OF PESTICIDE PROGRAMS

U.S. ENVIRONMENTAL PROTECTION AGENCY

SCREENING MODEL

FOR AQUATIC PESTICIDE EXPOSURE

 SciGrow version 2.3

 chemical:S-Metolachlor

 time is  4/ 8/2010  19:41:46

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

  Application      Number of       Total Use    Koc      Soil Aerobic

  rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism (days)

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

      3.810           1.0           3.810      2.16E+01       37.8

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

 groundwater screening cond (ppb) =   5.26E+00

 *********************************************************************** *

FIRST Output:  S-Metolachlor Degradate Ethanesulfonic Acid (ESA)

   RUN No.   1 FOR S-Metolachlor ESA ON   Caneberry     * INPUT VALUES *

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

   RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  %CROPPED INCORP

    ONE(MULT)    INTERVAL     Kd   (PPM )    (%DRIFT)     AREA    (IN)

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

  0.530(  0.530)   1   1       0.0  480.0   GRANUL( 0.0)  87.0     0.0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    162.50        2          N/A      0.00-    0.00     0.00      0.00

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.1  MAR 26, 2008

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

             47.611                     34.040

SCI-GROW Output:  S-Metolachlor Degradate Ethanesulfonic Acid (ESA)

SCIGROW

VERSION 2.3

ENVIRONMENTAL FATE AND EFFECTS DIVISION

OFFICE OF PESTICIDE PROGRAMS

U.S. ENVIRONMENTAL PROTECTION AGENCY

SCREENING MODEL

FOR AQUATIC PESTICIDE EXPOSURE

SciGrow version 2.3

chemical:S-Metolachlor ESA

time is  4/11/2010  10:39:35

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

Application      Number of       Total Use    Koc      Soil Aerobic

rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism (days)

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

0.530           1.0           0.530      2.01E+00      153.5

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

groundwater screening cond (ppb) =   4.59E+01

************************************************************************

FIRST Output:  S-Metolachlor Degradate Oxanillic Acid (OA)

RUN No.   1 FOR S-Metolachlor OA ON   Caneberry     * INPUT VALUES *

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

   RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  %CROPPED INCORP

    ONE(MULT)    INTERVAL     Kd   (PPM )    (%DRIFT)     AREA    (IN)

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

  1.050(  1.050)   1   1       0.1  480.0   GRANUL( 0.0)  87.0     0.0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    127.50        2          N/A      0.00-    0.00     0.00      0.00

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.1  MAR 26, 2008

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

66.617

SCI-GROW Output:  S-Metolachlor Degradate Oxanillic Acid (OA)

OFFICE OF PESTICIDE PROGRAMS

U.S. ENVIRONMENTAL PROTECTION AGENCY

SCREENING MODEL

FOR AQUATIC PESTICIDE EXPOSURE

SciGrow version 2.3

chemical:S-Metolachlor OA

time is  4/11/2010  11: 1:15

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

Application      Number of       Total Use    Koc      Soil Aerobic

rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism (days)

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

1.050           1.0           1.050      2.82E+00       93.8

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

groundwater screening cond (ppb) =   2.97E+01

************************************************************************

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