[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32078-32081]
[FR Doc No: 2013-12605]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-0406; Special Conditions No. 25-493-SC]

Special Conditions: Gulfstream Model G280 Airplane, Enhanced
Flight Vision System (EFVS) With Head-Up Display (HUD)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Gulfstream model
G280 series airplanes. These airplanes, as modified by Gulfstream
Aerospace Corporation, will have an advanced, enhanced-flight-vision
system (EFVS). The EFVS is a novel or unusual design feature which
consists of a head-up display (HUD) system modified to display forward-
looking infrared (FLIR) imagery. The applicable airworthiness
regulations do not contain adequate or appropriate safety standards for
this design feature. These special conditions contain the additional
safety standards that the Administrator considers necessary to
establish a level of safety equivalent to that established by the
existing airworthiness standards.

DATES: The effective date of these special conditions is May 22, 2013.
We must receive your comments by June 28, 2013.

ADDRESSES: Send comments identified by docket number FAA-2013-0406
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC, 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 8 a.m. and 5 p.m.,
Monday through Friday, except federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays.

FOR FURTHER INFORMATION CONTACT: Dale Dunford, FAA, Transport Standards
Staff, ANM-111, Transport Airplane Directorate, Aircraft Certification
Service, 1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone
(425) 227-2239 fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The FAA has determined that the substance of
these special conditions has been subject to the public-comment process
in several prior instances with no substantive comments received. The
FAA therefore finds that good cause exists for making these special
conditions effective upon issuance.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data. We ask
that you send us two copies of written comments.
    We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
concerning these special conditions. You can inspect the docket before
and after the comment closing date. If you wish to review the docket in
person, go to the address in the ADDRESSES section of this preamble
between 7:30 a.m. and 4:00 p.m., Monday through Friday, except Federal
holidays.
    We will consider all comments we receive on or before the closing
date for comments. We will consider comments filed late if it is
possible to do so without incurring expense or delay. We may change
these special conditions based on the comments we receive.

    If you want us to acknowledge receipt of your comments on this
proposal, include with your comments a self-addressed, stamped postcard
on which you have written the docket number. We will stamp the date on
the postcard and mail it back to you.

Background

    Note: The term ``enhanced vision system'' (EVS) in this document
refers to a system comprised of a head-up display, imaging sensor(s),
and avionics interfaces that display the sensor imagery on the HUD, and
which overlay that imagery with alpha-numeric and symbolic flight
information. However, the term has also been commonly used in reference
to systems that displayed the sensor imagery, with or without other
flight information, on a head-down display. For clarity, the FAA
created the term ``enhanced flight vision system'' (EFVS) to refer to
certain EVS systems that meet the requirements of the new operational
rules--in particular, the requirement for a HUD and specified flight
information--and which can be used to determine ``enhanced flight
vision.'' An EFVS can be considered a subset of a system otherwise
labeled EVS.
    On October 21, 2010, Gulfstream Aerospace Corporation applied to
the FAA, via a G280 STC project, for approval of the installation of an
Enhanced Flight Vision System (EFVS) with a head up display (HUD). The
EFVS is also capable of displaying forward-looking infrared (FLIR)
imagery. The original type certificate for the G280 airplanes is A61NM,
revision 3, November 5, 2012.
    The Gulfstream Model G280 is a two-crew-member transport business
jet with a maximum ramp weight of 39,750 lbs and is certified for up to
19 passengers.
    The electronic infrared image displayed between the pilot and the
forward windshield represents a novel or unusual design feature in the
context of 14 CFR 25.773. Section 25.773 was not written in
anticipation of such technology. The electronic image has the potential
to enhance the pilot's awareness of the terrain, hazards, and airport
features. At the same time, the image may partially obscure the pilot's
direct outside compartment view. Therefore, the FAA needs adequate
safety standards to evaluate the EFVS to determine that the imagery
provides the intended visual enhancements without undue interference
with the pilot's outside compartment view. The FAA intent is that the
pilot will be able to use a combination of the information seen in the
image, and the natural view of the outside scene seen through the
image, as safely and effectively as a pilot compartment view without an
EVS image, that is compliant with Sec.  25.773.
    Although the FAA has determined that the existing regulations are
not adequate for certification of EFVSs, it believes that EFVSs could
be certified through application of appropriate safety criteria.
Therefore, the FAA has determined that special conditions should be
issued for certification of EFVS to provide a level of safety
equivalent to that provided by the standard in Sec.  25.773.
    On January 9, 2004, the FAA published revisions to operational
rules in 14 CFR parts 1, 91, 121, 125, and 135 to allow aircraft to
operate below certain altitudes during a straight-in instrument
approach while using an EFVS to meet visibility requirements.
    Prior to this rule change, the FAA issued Special Conditions No.
25-180-SC, which applied to an EVS installed on Gulfstream Model G-V
airplanes. Those special conditions addressed the requirements for the
pilot compartment view and limited the scope of the intended functions
permissible under the operational rules at the time. The intended
function of the EVS imagery was to aid the pilot during the approach,
and allow the pilot to detect and identify the visual references for
the intended runway down to 100 feet above the touchdown zone. However,
the EVS imagery alone was not to be used as a means to satisfy
visibility requirements below 100 feet.
    The 2004 operational rule change expands the permissible
application of certain EVSs that are certified to meet the new EFVS
standards. This rule will allow the use of an EFVS for operation below
the minimum descent altitude or decision height to meet new visibility
requirements of Sec.  91.175(l). The purpose of these special
conditions is not only to address the issue of the ``pilot compartment
view,'' as was done by Special Conditions No. 25-180-SC, but also to
define the scope of intended function consistent with Sec.  91.175(l)
and (m).

Type Certification Basis

    Under the provisions of 14 CFR 21.101, Gulfstream must show that
the Model G280, as modified, complies with the regulations in the U.S.
type-certification basis established for those airplanes. The U.S.
type-certification basis for the airplanes is established in accordance
with Sec.  21.21 and 21.17, and the type certification application
date. The U.S. type-certification basis for these airplane models is
listed in Type Certificate Data Sheet No. A16NM, revision 3, November
5, 2012, which covers all variants of the Model G280 airplanes.
    In addition, the certification basis includes certain special
conditions and exemptions that are not relevant to these special
conditions. Also, if the regulations incorporated by reference do not
provide adequate standards with respect to the change, the applicant
must comply with certain regulations in effect on the date of
application for the change.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., part 25 as amended) do not contain adequate or
appropriate safety standards for the Gulfstream Model G280 airplanes,
modified by the applicant, because of a novel or unusual design
feature, special conditions are prescribed under the provisions of
Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate, to incorporate the same novel or unusual design feature,
the special conditions would also apply to the other model.
    Special conditions, as defined in Sec.  11.19, are issued in
accordance with Sec.  11.38 and become part of the type-certification
basis in accordance with Sec.  21.101.

Novel or Unusual Design Features

    The G280 airplanes will incorporate an EFVS, which is a novel or
unusual design feature. The EFVS is a novel or unusual design feature
because it projects a video image derived from a FLIR camera through
the HUD. The EFVS image is projected in the center of the ``pilot
compartment view,'' which is governed by Sec.  25.773. The image is
displayed with HUD symbology and overlays the forward outside view.
Therefore, Sec.  25.773 does not contain appropriate safety standards
for the EFVS display.
    Operationally, during an instrument approach, the EFVS image is
intended to enhance the pilot's ability to detect and identify ``visual
references for the intended runway'' (see Sec.  91.175(l)(3)) to
continue the approach below decision height or minimum descent
altitude. Depending on atmospheric conditions and the strength of
infrared energy emitted and/or reflected from the scene, the pilot can
see these visual references in the image better than he or she can see
them through the window without EFVS.
    Scene contrast detected by infrared sensors can be much different
from that

detected by natural pilot vision. On a dark night, thermal differences
of objects which are not detectable by the naked eye are easily
detected by many imaging infrared systems. On the other hand,
contrasting colors in visual wavelengths may be distinguished by the
naked eye but not by an imaging infrared system. Where thermal contrast
in the scene is sufficiently detectable, the pilot can recognize shapes
and patterns of certain visual references in the infrared image.
However, depending on conditions, those shapes and patterns in the
infrared image can appear significantly different than they would with
normal vision. Considering these factors, the EFVS image needs to be
evaluated to determine that it can be accurately interpreted by the
pilot.
    The EFVS image may improve the pilot's ability to detect and
identify items of interest. However, the EFVS needs to be evaluated to
determine that the imagery allows the pilot to perform the normal
flight-crew duties and adequately see outside the window through the
image, consistent with the safety intent of Sec.  25.773(a)(2).
    Compared to a HUD displaying the EFVS image and symbology, a HUD
that only displays stroke-written symbols is easier to see through.
Stroke symbology illuminates a small fraction of the total display area
of the HUD, leaving much of that area free of reflected light that
could interfere with the pilot's view out the window through the
display. However, unlike stroke symbology, the video image illuminates
most of the total display area of the HUD (approximately 30 degrees
horizontally and 25 degrees vertically) which is a significant fraction
of the pilot compartment view. The pilot cannot see around the larger
illuminated portions of the video image, but must see the outside scene
through it.
    Unlike the pilot's external view, the EFVS image is a monochrome,
two-dimensional display. Many, but not all, of the depth cues found in
the natural view are also found in the image. The quality of the EFVS
image and the level of EFVS infrared-sensor performance could depend
significantly on conditions of the atmospheric and external light
sources. The pilot needs adequate control of sensor gain and image
brightness, which can significantly affect image quality and
transparency (i.e., the ability to see the outside view through the
image). Certain system characteristics could create distracting and
confusing display artifacts. Finally, because this is a sensor-based
system intended to provide a conformal perspective corresponding with
the outside scene, the system must be able to ensure accurate
alignment. Therefore, safety standards are needed for each of the
following factors:
     An acceptable degree of image transparency;
     Image alignment;
     Lack of significant distortion; and
     The potential for pilot confusion or misleading
information.
    Section 25.773, Pilot compartment view, specifies that ``Each pilot
compartment must be free of glare and reflection that could interfere
with the normal duties of the minimum flight crew. . .'' In issuing
Sec.  25.773, the FAA did not anticipate the development of the EFVS
and does not consider that Sec.  25.773 adequately addresses the
specific issues related to such a system. Therefore, the FAA has
determined that special conditions are needed to address the specific
issues particular to the installation and use of an EFVS.

Discussion

    The EFVS is intended to present an enhanced view during the landing
approach. This enhanced view would help the pilot see and recognize
external visual references, as required by Sec.  91.175(l), and to
visually monitor the integrity of the approach, as described in FAA
Order 6750.24D (``Instrument Landing System and Ancillary Electronic
Component Configuration and Performance Requirements,'' dated March 1,
2000).
    Based on this approved functionality, users would seek to obtain
operational approval to conduct approaches--including approaches to
Type I runways--in visibility conditions much lower than those for
conventional Category I.
    The purpose of these special conditions is to ensure that the EFVS
to be installed can perform the following functions:
     Present an enhanced view that aids the pilot during the
approach.
     Provide enhanced flight visibility to the pilot that is no
less than the visibility prescribed in the standard instrument-approach
procedure.
     Display an image that the pilot can use to detect and
identify the ``visual references for the intended runway'' required by
14 CFR 91.175(l)(3), to continue the approach with vertical guidance to
100 feet height above the touchdown-zone elevation.
    Depending on the atmospheric conditions and the particular visual
references that happen to be distinctly visible and detectable in the
EFVS image, these functions would support its use by the pilot to
visually monitor the integrity of the approach path.
    Compliance with these special conditions does not affect the
applicability of any of the requirements of the operating regulations
(i.e., 14 CFR parts 91, 121, and 135). Furthermore, use of the EFVS
does not change the approach minima prescribed in the standard
instrument approach procedure being used; published minima still apply.
    The FAA certification of this EFVS is limited as follows:
    1. The infrared-based EFVS image will not be certified as a means
to satisfy the requirements for descent below 100 feet height above
touchdown.
    2. The EFVS may be used as a supplemental device to enhance the
pilot's situational awareness during any phase of flight or operation
in which its safe use has been established.
    3. An EFVS image may provide an enhanced image of the scene that
may compensate for any reduction in the clear outside view of the
visual field framed by the HUD combiner. The pilot must be able to use
this combination of information seen in the image and the natural view
of the outside scene, seen through the image, as safely and effectively
as the pilot would use a pilot compartment view without an EVS image
that is compliant with Sec.  25.773. This is the fundamental objective
of the special conditions.
    The FAA will also apply additional certification criteria, not as
special conditions, for compliance with related regulatory
requirements, such as Sec. Sec.  25.1301 and 25.1309. These additional
criteria address certain image characteristics, installation,
demonstration, and system safety.
    Image-characteristics criteria include the following:
     Resolution,
     Luminance,
     Luminance uniformity,
     Low-level luminance,
     Contrast variation,
     Display quality,
     Display dynamics (e.g., jitter, flicker, update rate, and
lag), and
     Brightness controls.
    Installation criteria address visibility and access to EFVS
controls, and integration of EFVS in the cockpit.
    The EFVS demonstration criteria address the flight and
environmental conditions that need to be covered.
    The FAA also intends to apply certification criteria relevant to
high-intensity radiated fields (HIRF) and lightning protection.

Applicability

    As discussed above, these special conditions are applicable to
Gulfstream Model G280 airplanes. Should

Gulfstream apply at a later date for a supplemental type certificate to
modify any other model included on Type Certificate No. A16NM to
incorporate the same novel or unusual design feature, the special
conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on Gulfstream Model G280 airplanes. It is not a rule of general
applicability and it affects only the applicant who applied to the FAA
for approval of these features on the airplane.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type-certification basis for Gulfstream Model G280 airplanes
modified by Gulfstream Aerospace Corporation.
    1. The EFVS imagery on the HUD must not degrade the safety of
flight or interfere with the effective use of outside visual references
for required pilot tasks during any phase of flight in which it is to
be used.
    2. To avoid unacceptable interference with the safe and effective
use of the pilot-compartment view, the EFVS device must meet the
following requirements:
    a. EFVS design must minimize unacceptable display characteristics
or artifacts (e.g. noise, ``burlap'' overlay, running water droplets)
that obscure the desired image of the scene, impair the pilot's ability
to detect and identify visual references, mask flight hazards, distract
the pilot, or otherwise degrade task performance or safety.
    b. Control of EFVS display brightness must be sufficiently
effective, in dynamically changing background (ambient) lighting
conditions, to prevent full or partial blooming of the display that
would distract the pilot, impair the pilot's ability to detect and
identify visual references, mask flight hazards, or otherwise degrade
task performance or safety. If automatic control for image brightness
is not provided, it must be shown that a single manual setting is
satisfactory for the range of lighting conditions encountered during a
time-critical, high-workload phase of flight (e.g., low-visibility
instrument approach).
    c. A readily accessible control must be provided that permits the
pilot to immediately deactivate and reactivate display of the EFVS
image on demand without removing the pilot's hands from the primary
flight controls (yoke or equivalent) or thrust control.
    d. The EFVS image on the HUD must not impair the pilot's use of
guidance information, or degrade the presentation and pilot awareness
of essential flight information displayed on the HUD, such as alerts,
airspeed, attitude, altitude and direction, approach guidance, wind
shear guidance, TCAS resolution advisories, and unusual-attitude
recovery cues.
    e. The EFVS image and the HUD symbols, which are spatially
referenced to the pitch scale, outside view, and image, must be scaled
and aligned (i.e., conformal) to the external scene and, when
considered singly or in combination, must not be misleading, cause
pilot confusion, or increase workload. Some airplane attitudes or
cross-wind conditions may cause certain symbols, such as the zero-pitch
line or flight-path vector, to reach field-of-view limits such that
they cannot be positioned conformably with the image and external
scene. In such cases, these symbols may be displayed, but with an
altered appearance which makes the pilot aware that they are no longer
displayed conformably (for example, ``ghosting'').
    f. A HUD system used to display EFVS images must, if previously
certified, continue to meet all of the requirements of the original
approval.
    3. The safety and performance of the pilot tasks associated with
the use of the pilot-compartment view must not be degraded by the
display of the EFVS image. Pilot tasks that must not be degraded by the
EFVS image include:
    a. Detection, accurate identification, and maneuvering, as
necessary, to avoid traffic, terrain, obstacles, and other hazards of
flight.
    b. Accurate identification and utilization of visual references
required for every task relevant to the phase of flight.
    4. Appropriate limitations must be stated in the Operating
Limitations section of the Airplane Flight Manual to prohibit the use
of the EFVS for functions for which EFVS has not been found to be
acceptable.

    Issued in Renton, Washington, on May 22, 2013.
Jeff Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-12605 Filed 5-28-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55847-55851]
[FR Doc No: 2021-21970]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0271]

Hospital and Health System Compounding Under Section 503A of the
Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry entitled
``Hospital and Health System Compounding Under Section 503A of the
Federal Food, Drug, and Cosmetic Act'' (``revised draft guidance'').
This revised draft guidance, when finalized, will describe how FDA
intends to apply certain provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to human drug products compounded by State-
licensed pharmacies that are not outsourcing facilities and distributed
for use within a hospital or health system. First, it addresses the
requirement that compounding be based on the receipt of a valid
prescription order for an identified individual patient. Second, it
addresses the provision concerning compounded drug products that are
essentially copies of a commercially available drug product. This draft
guidance revises the draft guidance issued in 2016 entitled, ``Hospital
and Health System Compounding Under the Federal Food, Drug, and
Cosmetic Act'' (``draft guidance''). FDA is revising the draft guidance
to address stakeholder feedback and provide further clarification on
policies regarding hospital and health system compounding. This revised
draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the revised
draft guidance by December 6, 2021 to ensure that the Agency considers
your comment on this revised draft guidance before it begins work on
the final version of the guidance. Submit electronic or written
comments on the proposed collection of information in the revised draft
guidance by December 6, 2021.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-0271 for ``Hospital and Health System Compounding Under
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this revised draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your request or include a fax number to which the
revised draft guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the revised draft
guidance.

FOR FURTHER INFORMATION CONTACT:
    With regard to the revised draft guidance: Tracy Rupp, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993,<PHONE_NUMBER>.
    With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Hospital and Health System Compounding Under
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' Pharmacies
located within a hospital, or standalone pharmacies that are part of a
health system, frequently provide compounded drug products for
administration within the hospital or health system. Some of these
compounders seek to compound under section 503A of the FD&C Act (21
U.S.C. 353a) and others have registered with FDA as outsourcing
facilities and are subject to section 503B of the FD&C Act (21 U.S.C.
353b).
    Section 503A of the FD&C Act describes the conditions that must be
satisfied for human drug products compounded by a licensed pharmacist
in a State-licensed pharmacy or Federal facility, or by a licensed
physician, to be exempt from the following three sections of the FD&C
Act:
     Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice (CGMP) requirements);
     Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate directions for use); and
     Section 505 (21 U.S.C. 355) (concerning the approval of
drugs under new drug applications or abbreviated new drug
applications).
    This revised draft guidance proposes policies for FDA's application
of certain provisions of section 503A of the FD&C Act to human drug
products compounded by State-licensed pharmacies that are not
outsourcing facilities and distributed for use within a hospital or
health system. First, the revised draft guidance addresses the
requirement that compounding be based on the receipt of a valid
prescription order for an identified individual patient. Second, it
addresses the provision concerning compounded drug products that are
essentially copies of a commercially available drug product. This
revised draft guidance does not apply to human drug products compounded
by outsourcing facilities under section 503B of the FD&C Act,
compounded drug products that are not distributed for use within a
hospital or health system, or drug products compounded for use in
animals.
    In the Federal Register of April 18, 2016 (81 FR 22610), FDA
announced the availability of a draft guidance for industry entitled,
``Hospital and Health System Compounding Under the Federal Food, Drug,
and Cosmetic Act''

(``draft guidance''). The draft guidance proposed new policies for the
application of section 503A of the FD&C Act to drug products compounded
by licensed pharmacists or physicians in State-licensed hospital or
health system pharmacies. In particular, the draft guidance described
certain circumstances under which FDA generally would not intend to
take action if a hospital or health system pharmacy distributed
compounded drug products without first receiving a patient-specific
prescription or order.
    The comment period on the initial draft guidance ended on July 18,
2016. FDA received approximately 76 comments on the draft guidance. FDA
is issuing a revised draft guidance with certain changes made in
response to received comments or on its own initiative. For example,
the prescription requirement enforcement policy described in the
revised draft guidance does not consider whether the drug products are
distributed only to healthcare facilities that are located within a 1-
mile radius of the compounding pharmacy (``1-mile radius policy'').
Instead, the Agency is proposing a two-part, risk-based compliance
policy.
    In addition, the revised draft guidance proposes new policies for
hospital and health system pharmacies regarding the provision in
section 503A of the FD&C Act which states that to qualify for the
exemptions under section 503A of the FD&C Act, among other conditions,
a drug product must be compounded by a licensed pharmacist or physician
who does not compound regularly or in inordinate amounts any drug
products that are essentially copies of a commercially available drug
product.
    FDA is issuing this revised draft guidance to address stakeholders'
feedback, reflect additional Agency consideration of the proposed
policies, and enable the public to further review and comment before
finalization.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Hospital and Health System Compounding Under Section 503A of the
Federal Food, Drug, and Cosmetic Act.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document. We
are consolidating the information collection in the revised draft
guidance with the information collections and approvals under OMB
control number 0910-0800.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Human Drug Compounding Under Sections 503A and 503B the Federal Food,
Drug, and Cosmetic Act

OMB Control Number 0910-0800--Revision

    This notice solicits comments on certain information collections
found in the revised draft guidance entitled ``Hospital and Health
System Compounding Under Section 503A of the Federal Food, Drug, and
Cosmetic Act'' (``revised draft guidance''). This guidance, when
finalized, will support implementation of the copies provisions of the
1997 Food and Drug Administration Modernization Act (FDAMA) (Pub. L.
105-115) discussed in section 503A of the FD&C Act, which were
maintained by the 2013 Drug Quality and Security Act (DQSA) (Title I of
Pub. L. 113-54).
    For efficiency of Agency operations, we are revising OMB control
number 0910-0800 to include information collections relating to the
copies policies for hospital and health system pharmacies that are not
outsourcing facilities, as proposed in the revised draft guidance
document.
    As proposed in section III.B of the revised draft guidance, among
other conditions, we generally would not intend to take action against
a hospital or health system pharmacy that is not an outsourcing
facility for compounding a drug product regularly or in inordinate
amounts that is essentially a copy of a commercially available drug
product, if the compounded drug product is administered only to
patients within the hospital or health system and the pharmacy obtains
from the prescriber a statement that: (1) Specifies a change between
the compounded drug product and the commercially available drug
product; (2) indicates that the compounded drug product will be
administered only to patients for whom the change produces a
significant difference from the commercially available drug product;
and (3) describes the intended patient population for the compounded
drug product. In addition, the revised draft guidance specifies that
the statement would be maintained in the hospital or health system
pharmacy to address routine orders for patients for whom the change
produces a significant difference, and a statement would be on file for
each prescriber that covers each drug product that is compounded.
    As provided in section III.B of the revised draft guidance, except
for the policy proposed above regarding the documentation of a
prescriber's determination of significant difference, we propose to
apply the policies described in the guidance, ``Compounded Drug
Products That Are Essentially Copies of a Commercially Available Drug
Product Under Section 503A of the Federal Food, Drug, and Cosmetic
Act'' (``503A copies guidance'') to drug products compounded by
hospital and health system pharmacies that are not outsourcing
facilities.
    As described in section III.B.2 of the 503A copies guidance, and
proposed in the revised draft guidance to apply to hospital and health
system pharmacies, if a compounder intends to rely on a prescriber
determination of significant difference to establish that a compounded
drug is not essentially a copy of a commercially available drug
product, the compounder should ensure that the determination is
documented on the prescription. If a prescription

does not make clear that the prescriber made the determination required
by section 503A(b)(2) of the FD&C Act, or a compounded drug is
substituted for the commercially available drug product, the compounder
can contact the prescriber and if the prescriber confirms it, make a
notation on the prescription that the compounded drug product contains
a change that makes a significant difference for the patient. The
notations should be as specific as those described in the 503A copies
guidance, and the date of the conversation with the prescriber should
be included on the prescription.
    With respect to the determination of significant difference
described above, we estimate that, annually, a total of approximately
3,075 hospital or health system pharmacies (table 1) will obtain a
prescriber determination of significant difference. This estimate
represents approximately half of the hospitals in the United States,
including those that are in health systems. Of these, we estimate that
approximately half (1,538) will have hospital or health system
pharmacies that will follow the policy in the revised draft guidance,
obtaining a statement of significant difference for the intended
patient population, and approximately half (1,537) will have hospital
or health system pharmacies that will follow the policy with respect to
prescriber determination of significant difference in the 503A copies
guidance, documenting the notation on the individual patient
prescription. This estimate assumes that most pharmacies in smaller
hospitals and health systems will follow the policy in the 503A copies
guidance because a prescriber determination of significant difference
will not be routinely needed and can be most efficiently managed on a
patient-by-patient basis. On the other hand, this estimate assumes that
most pharmacies in larger hospitals and health systems will follow the
policy in the revised draft guidance because the need for a prescriber
determination of significant difference is more routinely necessary
and, therefore, most efficiently managed with a statement of
significant difference that is maintained in the hospital or health
system pharmacy to address routine orders for patients for whom the
change produces a significant difference.
    We estimate that, annually, approximately 1,538 hospital or health
system pharmacies following the policy in the revised draft guidance
will obtain approximately 30 statements of significant difference for
compounded drug products, for a total of approximately 46,140
statements (table 1, row 1). We estimate that the consultation between
the hospital or health system pharmacy and the prescriber to obtain the
statement of significant difference will require approximately 5
minutes per statement (table 1, row 1).
    We estimate that, annually, approximately 1,537 hospital or health
pharmacies following the policy in the 503A copies guidance will
consult a prescriber to determine whether the prescriber has made a
determination that the compounded drug product has a change that
produces a significant difference for a patient as compared to the
comparable commercially available drug and that the compounders will
document this determination on approximately 76,850 prescription orders
for compounded drug products (table 1, row 2). We estimate that the
consultation between the compounder and the prescriber and adding a
notation to each prescription that does not already document this
determination will take approximately 3 minutes per prescription order
(table 1, row 2). The average burden per consultation and notation for
pharmacies following the significant difference policy in the 503A
copies guidance, compared to pharmacies following the significant
difference policy in the revised draft guidance, is estimated to be
less (3 minutes) because the significant difference determination
described in the 503A copies policy is specific to one patient, whereas
the statement of significant difference in the revised draft guidance
describes the intended patient population.
    In addition, as described in section III.B.3 of the 503A copies
guidance, and proposed in the revised draft guidance to apply to
hospital and health system pharmacies, if the drug product was
compounded because the approved drug product was not commercially
available because it was on the FDA drug shortage list, the
prescription or a notation on the prescription should note that it was
on the drug shortage list and note the date the list was checked. We
estimate that a total of approximately 4,613 hospital or health system
pharmacies will document this information on approximately 922,600
prescription orders for compounded drug products (table 1, row 3). We
estimate that checking FDA's drug shortage list and documenting this
information will require approximately 2 minutes per prescription order
(table 1, row 3).
    With respect to maintaining records of the statement of significant
difference proposed in section III.B of the revised draft guidance, we
estimate that a total of approximately 1,538 hospital or health system
pharmacies will maintain approximately 46,140 statements of significant
difference (table 2, row 1). We estimate that maintaining the records
will require approximately 2 minutes per record (table 2, row 1). With
respect to maintaining records of the significant difference
determination, as provided in section III.B.5 of the 503A copies
guidance, we estimate that a total of approximately 1,537 hospital or
health system pharmacies will maintain approximately 76,850 records
(table 2, row 2). We estimate that maintaining records will require
approximately 2 minutes per record (table 2, row 2).
    Also with respect to maintenance of records, as described in
section III.B.5 of the 503A copies guidance, and proposed in the
revised draft guidance to apply to hospital and health system
pharmacies, compounders under section 503A should maintain records of
(1) the frequency in which they have compounded drug products that are
essentially copies of commercially available drug products and (2) the
number of prescriptions that they have filled for compounded drug
products that are essentially copies of commercially available drug
products. We estimate that a total of approximately 3,075 hospital or
health system pharmacies will maintain approximately 61,500 records of
prescriptions that they have filled for compounded drug products that
are essentially copies of commercially available drug products (table
2, row 3). We estimate that maintaining the records will require
approximately 2 minutes per record (table 2, row 3).
    We estimate the burden of this collection of information as
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of       Total
            Activity               Number of     disclosures      annual       Average burden per    Total hours
                                  respondents  per respondent  disclosures         disclosure
----------------------------------------------------------------------------------------------------------------
Consultation between the                1,538              30       46,140  .08 (5 minutes)........        3,691
 hospital or health system
 pharmacy and the prescriber to
 document the statement of
 significant difference (revised
 draft guidance).
Consultation between the                1,537              50       76,850  .05 (3 minutes)........        3,843
 hospital or health system
 pharmacy and prescriber and the
 notation on the prescription
 documenting the prescriber's
 determination of significant
 difference (503A copies
 guidance).
Hospital or health system               4,613             200      922,600  .03 (2 minutes)........       27,678
 pharmacy checking FDA's drug
 shortage list and documenting
 on the prescription that the
 drug is in shortage (503A
 copies guidance).
                                 -------------------------------------------------------------------------------
    Total.......................  ...........  ..............  ...........  .......................       35,212
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of       Total
            Activity               Number of      records per      annual      Average burden per    Total hours
                                 recordkeepers   recordkeeper     records         recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of the statement of             1,538               30       46,140  .03 (2 minutes).......        1,384
 significant difference
 (revised draft guidance).
Records of documentation of             1,537               50       76,850  .03 (2 minutes).......        2,306
 significant difference (503A
 copies guidance).
Records of frequency and number         3,075               20       61,500  .03 (2 minutes).......        1,845
 of prescriptions filled for
 compounded drug products that
 are essentially a copy (503A
 copies guidance).
                                --------------------------------------------------------------------------------
    Total......................  .............  ..............  ...........  ......................        5,535
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the revised draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-21970 Filed 10-6-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 60 (Friday, March 27, 2020)]
[Notices]
[Pages 17329-17331]
[FR Doc No: 2020-06515]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2020-0075; FRL-10007-13-OLEM]

Hazardous Waste Electronic Manifest System (``e-Manifest'')
Advisory Board; Revised Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Revised notice.

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

SUMMARY: The Environmental Protection Agency (EPA) will convene the
Hazardous Waste Electronic System (``e-Manifest'') Advisory Board for a
three day virtual public meeting (held remotely via webcast and phone)
to seek the Board's consultation and recommendations regarding the e-
Manifest system (Meeting Theme: ``Reengineering Electronic Signatures
for Generators and Transporters to Increase Adoption of Electronic
Manifests''). This notice is a revision of the notice published in the
Federal Register (FR) of February 20, 2020, announcing the e-Manifest
public meeting. Due to potential impacts from the Coronavirus Disease
2019 (COVID-19), EPA is converting this public e-Manifest Advisory
Board meeting from an in-person meeting to a fully virtual meeting and
is thus updating information accordingly.

DATES: The e-Manifest Advisory Board meeting announced on February 20,
2020 (85 FR 9763) has been converted to a three-day virtual public
meeting which will be held on April 14-16, 2020, from approximately
10:00 a.m. to 6:00 p.m. (EDT) each day.

ADDRESSES: This public meeting will be conducted entirely via internet
webcasting and telephone. Please refer to the e-Manifest website at
www.epa.gov/e-manifest for information on how to access the live
webcasting of this public meeting.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the Designated Federal Officer (DFO) listed
under FOR FURTHER INFORMATION CONTACT at least ten (10) days prior to
the meeting to give the EPA as much time as possible to process your
request.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact the e-Manifest Advisory Board DFO,
Fred Jenkins, U.S. Environmental Protection Agency, Office of Resource
Conservation and Recovery, (MC: 5303P), 1200 Pennsylvania Avenue NW,
Washington, DC 20460, Phone:<PHONE_NUMBER>; or by email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Meeting access: This meeting will be open to the public. The full
agenda and meeting materials will be available in the docket for the
meeting and at the e-Manifest website at www.epa.gov/e-manifest. This
public meeting will be conducted entirely virtually via the internet
and by telephone. Please refer to the e-Manifest website at
www.epa.gov/e-manifest for information on how to access the live
webcasting of this public meeting. For questions on document
availability, or if you do not have access to the internet, consult
with the DFO, Fred Jenkins, listed above under FOR FURTHER INFORMATION
CONTACT. In the event the Agency needs to make subsequent changes to
this meeting, the Agency will post future notices to its e-Manifest
website (www.epa.gov/e-manifest). The Agency strongly encourages the
public to refer to the e-Manifest website for the latest meeting
information, as sudden changes may be necessary.

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may
be of particular interest to persons who are or may be subject to the
Hazardous Waste Electronic Manifest Establishment (e-Manifest) Act.

B. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this document. To ensure proper receipt of your public comments by
the EPA, it is imperative that you identify docket ID number EPA-HQ-
OLEM-2020-0075.
    1. Oral comments. To pre-register to make oral comments, please
contact the DFO, Fred Jenkins, listed under FOR FURTHER INFORMATION
CONTACT. Requests to present oral comments during the

meeting will be accepted up until Tuesday April 7, 2020. To the extent
that time permits, interested persons who have not pre-registered may
be permitted by the e-Manifest Advisory Board Chair to present oral
comments during the virtual meeting at the designated time on the
agenda. Oral comments before the e-Manifest Advisory Board are limited
to approximately five (5) minutes per individual and/or organization
unless prior arrangements have been made.
    2. Written comments. The Agency encourages written comments for the
virtual webcast meeting be submitted via regulations.gov under docket
number EPA-HQ-OLEM-2020-0075 on or before April 7, 2020, to provide the
e-Manifest Advisory Board the time necessary to consider and review the
written comments. The e-Manifest Advisory Board may not be able to
fully consider written comments submitted after April 7, 2020. Written
comments are accepted until the date of the meeting, but anyone
submitting written comments after April 7, 2020, should contact the DFO
listed under FOR FURTHER INFORMATION CONTACT.

C. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact the DFO
listed under FOR FURTHER INFORMATION CONTACT to obtain special
instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see Tips for Effective Comments at http://www.epa.gov/dockets/comments.html.

C. Purpose of the e-Manifest Advisory Board

    The Hazardous Waste Electronic Manifest System Advisory Board is
established in accordance with the provisions of the Hazardous Waste
Electronic Manifest Establishment Act, 42 U.S.C. 6939g, and the Federal
Advisory Committee Act (FACA), 5 U.S.C. App.2. The e-Manifest Advisory
Board is in the public interest and supports the EPA in performing its
duties and responsibilities.
    The e-Manifest Advisory Board will provide recommendations on
matters related to the operational activities, functions, policies, and
regulations of the EPA under the e-Manifest Act, including: The
effectiveness of the e-Manifest IT system and associated user fees and
processes; matters and policies related to the e-Manifest program;
regulations and guidance as required by the e-Manifest Act; actions to
encourage the use of the electronic (paperless) system; changes to the
user fees as described in e-Manifest Act Section 2 (c)(3)(B)(i); and
issues in the e-Manifest area, including those identified in the EPA' s
E-Enterprise strategy that intersect with the e-Manifest system, such
as: Business-to-business communications; performance standards for
mobile devices; and the EPA's Cross Media Electronic Reporting Rule
(CROMERR) requirements.
    The sole duty of the Advisory Board is to provide advice and
recommendations to the EPA Administrator. As required by the e-Manifest
Act, the e-Manifest Advisory Board is composed of nine (9) members. One
(1) member is the EPA Administrator (or a designee), who serves as
Chairperson of the Advisory Board. The rest of the committee is
composed of:
     At least two (2) members who have expertise in information
technology;
     At least three (3) members who have experience in using or
represent users of the manifest system to track the transportation of
hazardous waste under the e-Manifest Act;
     At least three (3) members who are state representatives
responsible for processing manifests.
    All members of the e-Manifest Advisory Board, except for the EPA
Administrator, are appointed as Special Government Employees or
representatives.

D. Public Meeting

    EPA launched the e-Manifest system on June 30, 2018. e-Manifest
enables those persons required to use a Resource Conservation and
Recovery Act manifest under either federal or state law to have the
option of using electronic manifests to track shipments of hazardous
waste and to meet certain RCRA requirements. By enabling the transition
from a paper-intensive process to an electronic system, the EPA
estimates e-Manifest will ultimately save state and industry users more
than $50 million annually, once electronic manifests are widely
adopted.
    EPA will convene its next public meeting of the e-Manifest System
Advisory Board from April 14-16, 2020. The purpose of this meeting is
for the Board to advise the Agency on its proposed additional methods
for increasing the use of electronic manifests, which include
reengineering electronic signatures for generators and transporters to
reduce the administrative burdens and barriers to electronic
manifesting.
    Since the launch of e-Manifest, the Agency has learned through
experience that it can likely increase adoption of electronic manifests
by providing generators and transporters more flexibility in their
methods for performing electronic signatures. This is supported by the
final recommendations of the e-Manifest Advisory Board, following its
June 2019 Advisory Board meeting, which was focused on increasing
adoption of the e-Manifest system. In its final recommendations,
delivered to the Agency on September 23, 2019, the Advisory Board
identified numerous challenges with generator and transporter adoption
of electronic manifests. In particular, the Advisory Board asked the
Agency to reevaluate its signature requirements and stated that the
Agency should consider the costs and benefits, given the diversity of
roles/types of users.
    The Agency is thus considering additional methods available for
generator and transporter electronic signatures and will consult the
Advisory Board on these methods during the April 2020 Advisory Board
meeting. Specifically, EPA will present three methods for generator/
transporter electronic signature, which could potentially all be
available for generators and transporters to use.
    A first method for generators and transporters is to require at
least one person (per respective generator and transporter) to become
registered in EPA's RCRAInfo system as a ``Site Manager.'' (Note: The
Agency is not intending at this time to make any changes to the current
registration process for Site Managers as this role allows users to
manage permissions within their organization with respect to other
modules in EPA's RCRAInfo system, in addition to e-Manifest.) Under
this method, the Site Manager would identify/confirm/update the
specific personnel (e.g., employee on the loading dock, driver) on the
electronic manifest who will have firsthand knowledge of the manifest
shipment, and who will be responsible for electronically signing the
generator certification or transporter acknowledgment of receipt by
identifying/confirming/updating the name and either a phone number or
email address associated with that name. The system would then send a
link to that phone number/email of the individual employee, who could
then simply click a link to electronically sign the electronic
manifest.
    A second method for generators and transporters is to require at
least one

person to become registered in EPA's RCRAInfo system as a ``Site
Manager'' for their respective sites, and have all other personnel
become registered in the same way as ``Preparers'' are registered.
These personnel would receive a username and password using the current
registration process and would then request access to their site(s), as
appropriate, but would not need to undergo further identity proofing.
Generator and transporter personnel that are registered could then log
in with their username/password and could create and edit electronic
manifests for their sites. Electronic signatures under this method for
generators and transporters would consist of, after logging in to their
account, clicking a button to electronically sign.
    A third method is for generators and transporters to use digitized
signature pads that have been approved by the Agency under its CROMERR
program. This method would require generators and transporters to
possess units that allow them to capture a physical signature
electronically, for example, using a stylus.
    The Agency intends to provide more detail regarding these methods
in its meeting materials, which will be published in the docket for the
meeting.

E. e-Manifest Advisory Board Documents and Meeting Minutes

    The meeting background paper, related supporting materials, charge/
questions to the Advisory Board, the Advisory Board membership roster
(i.e., members attending this meeting), and the meeting agenda are
available in the docket for this meeting. In addition, the Agency may
provide additional background documents as the materials become
available. You may obtain electronic copies of these documents, and
certain other related documents that might be available at https://www.regulations.gov/ and the e-Manifest Advisory Board website at:
https://www.epa.gov/e-manifest/hazardous-waste-electronic-manifest-system-e-manifest-advisory-board.
    The e-Manifest Advisory Board will prepare meeting minutes
summarizing its recommendations to the Agency approximately ninety (90)
days after the meeting. The meeting minutes will be posted on the e-
Manifest Advisory Board website or may be obtained from the docket at
http://www.regulations.gov/.

    Dated: March 23, 2020.
Donna Salyer,
Acting Director, Office of Resource Conservation and Recovery, Office
of Land and Emergency Management.
[FR Doc. 2020-06515 Filed 3-26-20; 8:45 am]
BILLING CODE 6560-50-P


Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 1 of 15 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: 20 APR 2006 SUBJECT: Quinoxyfen: Chronic Aggregate Dietary ( Food and Drinking Water) Exposure and Risk Assessment for the Proposed Section 3 Registration on Peppers ( PP# 3E6755); Melon Subgroup 9A ( PP# 5E6969); Strawberry ( PP# 5E6970); and Lettuce ( Head and Leaf) ( PP# 5E6970).

PC Code: 055459 Decision Number: 354885 DP Number: 328363 REVIEWER: Susan L. Stanton, Environmental Scientist Reregistration Branch 3 Health Effects Division ( 7509C)

THROUGH: Thomas Bloem, Chemist David Soderberg, Chemist Dietary Exposure Science Advisory Council ( DESAC) Health Effects Division ( 7509C)

and P. V. Shah, Branch Senior Scientist Registration Action Branch 1 Health Effects Division ( 7509C)

TO: George F. Kramer, Ph. D., Chemist Registration Action Branch 1 Health Effects Division ( 7509C)

and Dan Rosenblatt, Chief Minor Use, Inerts & Emergency Response Branch Registration Division ( 7505C) Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 2 of 15 Executive Summary A chronic dietary risk assessment was conducted using the Dietary Exposure Evaluation Model ( DEEM FCID   ) , Version 2.03, which uses food consumption data from the U. S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals ( CSFII) from 1994 1996 and 1998. The analysis was performed to support FIFRA § 3 registration requests for the fungicide, quinoxyfen, on peppers ( bell and non bell), lettuce ( head and leaf), strawberry and melons.

No toxic effects attributable to a single ( i. e., acute) exposure to quinoxyfen have been identified; therefore, an acute Reference Dose ( aRfD) has not been established for quinoxyfen and an acute dietary exposure assessment has not been conducted. Also, since there is no evidence that quinoxyfen is carcinogenic to humans, a dietary cancer assessment is not required.

Chronic Dietary Exposure Results and Characterization The tier 1 chronic assessment assumed that quinoxyfen residues are present in all commodities at tolerance levels and that 100% of all crops are treated. DEEM   Version 7.81 default processing factors were used to estimate residues in cherry juice, grape juice and raisins. Drinking water was incorporated directly into the dietary assessment using the estimated drinking water concentration ( EDWC) for surface water generated by the PRZM EXAMS model.

The resulting chronic dietary exposure estimates for food and water combined are well below HED's level of concern ( i. e., < 100% of the cPAD of 0.2 mg/ kg bw/ day) for the overall U. S. population and all population subgroups. Using the DEEM FCID software, dietary exposure is estimated at 0.002596 mg/ kg/ day for the U. S. population ( 1.3% of the cPAD) and 0.003923 mg/ kg/ day ( 2.0% of the cPAD) for children 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to quinoxyfen.

I. Introduction Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose ( i. e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population adjusted dose ( PAD). The PAD is equivalent to the reference dose ( RfD) divided by the special Food Quality Protection Act ( FQPA) Safety Factor.

For chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the cPAD. References which discuss the chronic risk assessment in more detail are available on the EPA/ pesticides web site: " Available Information on Assessing Exposure from Pesticides, A User's Guide," 6/ 21/ 2000, web link: http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf ; or see SOP 99.6 ( 8/ 20/ 99).

The most recent HED dietary risk assessment for quinoxyfen was conducted by Jennifer Tyler ( 03/ 25/ 2003, DP285313) to support the first food uses of quinoxyfen ( cherries, grapes and hops). A subsequent assessment to support the FIFRA § 18 uses on melons, pumpkins and winter squash was conducted by the Registration Division's ARIA team in August, 2004 ( D302199). Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 3 of 15 II. Food Residue Information Residues of Concern: Based on the previously submitted cucumber, grape, sugar beet and tomato metabolism studies, the nature of the residue in plants is adequately understood. The residue of concern for tolerance and risk assessment purposes is quinoxyfen, per se.

Tolerances: Permanent tolerances have been established under 40 CFR § 180.588( a) for residues of quinoxyfen, 5,7 dichloro 4( 4 fluorophenoxy) quinoline, in or on cherry ( sweet and tart) at 0.3 ppm, dried hop cones at 3.0 ppm and grape at 0.6 ppm. Time limited tolerances for residues of quinoxyfen have been established on pumpkin, winter squash and melons ( cucurbit vegetable subgroup 9A) at 0.3 ppm in connection with FIFRA § 18 emergency exemptions. These timelimited tolerances expire on 12/ 31/ 2007.

IR 4 has proposed new tolerances for residues of quinoxyfen in or on the following commodities: pepper, bell; pepper, non bell; eggplant; sub group 9A ( melon); lettuce, leaf; lettuce, head; and strawberry. HED has reviewed residue data submitted to support these tolerances and concluded that the following tolerances are appropriate [ George Kramer; April, 2006; DP 323549, 327820, 327822].

Crop Commodity Recommended Tolerance ( ppm)

Pepper, bell 0.35 Pepper, non bell 1.7 Eggplant1 To be determined Melon, sub Group 9A 0.08 Lettuce, leaf 19 Lettuce, head 7.0 Strawberry 0.90 1Additional data are required to support the tolerance/ use on eggplant.

Residue Data used for the Chronic Assessment: The unrefined, tier 1 chronic assessment assumed that quinoxyfen residues are present in all commodities at established or, for the new crops, recommended tolerance levels and that 100% of all crops are treated. DEEM   Version 7.81 default processing factors were used to estimate residues in cherry juice, grape juice and raisins.

The recommended permanent tolerance for melons of 0.08 ppm was used instead of the higher, time limited tolerance of 0.3 ppm, since HED is recommending that the time limited tolerance be revoked concurrent with the establishment of the permanent tolerance for melons.

The proposed use of quinoxyfen on eggplant was not considered in this assessment, since additional data are required and HED is not recommending that a tolerance be established at this time. Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 4 of 15 III. Drinking Water Data Reference: EFED Drinking Water Assessment for the IR 4 Tolerance Petition for Use of Quinoxyfen on Lettuce, Strawberries, Melons, Peppers ( Bell and Non bell), and Eggplants; Cheryl Sutton; 03/ 23/ 2006; D314492.

The residue of concern in drinking water is quinoxyfen, per se. The A EFED Risk Assessment for the Section 3 Registration of Quinoxyfen @

( DP Barcodes: D278515, D285770, D286376) was completed in August 2003. Uses included in the assessment were grapes, hops and cherries. In that assessment, estimated drinking water concentrations ( EDWCs) for use in the human health risk assessment were determined using a maximum annual application rate for cherries of 0.55 lb a. i./ A. Because maximum application rates for the proposed uses on lettuce, strawberries, melons and peppers do not exceed the application rate for cherries, the previously generated EDWCs are still current and were used in this dietary exposure assessment.

Table 2. EDWCs for the drinking water assessment based on quinoxyfen use on cherries.

Surface water drinking water sources acute: 13.34 ug/ L ( ppb) 1 1 in 10 years ( chronic): 8.35 ug/ L ( ppb) 30 year average: 5.95 ug/ L ( ppb)

Groundwater drinking water sources 0.00600 ug/ L ( ppb) or 6.00 ng/ L ( parts per trillion) 1EDWC values were generated using the PRZM/ EXAMS model with an orchard airblast spray to cherries in Michigan application scenario which represents the highest annual application rate among the registered and proposed new uses.

The highest chronic quinoxyfen concentration was estimated for surface water using the PRZM/ EXAMS model. The model and its description are available at the EPA internet site: http:// www. epa. gov/ oppefed1/ models/ water/. The chronic ( 1 in 10 year annual mean) value of 8.35 ppb was incorporated directly as a point estimate in the DEEM analysis to assess exposure to quinoxyfen from drinking water.

IV. DEEM FCID   Program and Consumption Information A quinoxyfen chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEM FCID   , Version 2.03), which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998. The 1994 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non consecutive survey days. Foods " as consumed" ( e. g., apple pie) are linked to EPA defined food commodities ( e. g. apples, peeled fruit  cooked; fresh or N/ S; baked; or wheat flour  cooked; fresh or N/ S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U. S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on analysis of the 1994 96, 98 CSFII consumption data, which took Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 5 of 15 into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U. S. population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, females 13 49, and adults 50+ years old.

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

V. Toxicological Information Quinoxyfen was presented to the HED Hazard Identification Assessment and Review Committee ( HIARC) on 12/ 10/ 02 ( Memo, D. Nixon, 1/ 28/ 03; TXR No. 0051474). Based on the HIARC conclusions and the quinoxyfen risk assessment team's evaluation of the hazard and exposure data, the team recommended that the special FQPA Safety Factor be reduced to 1x. A summary of the toxicological doses and endpoints selected for dietary exposure assessment is provided below in Table 3.

Table 3. Summary of Toxicological Doses and Endpoints for Quinoxyfen for Use in Dietary Exposure Assessment Exposure Scenario Dose Used in Risk Assessment, UF Hazard and Exposure Based Special FQPA Safety Factor Study and Toxicological Effects Acute Dietary All Populations Not Applicable Not Applicable No endpoint attributable to a single exposure was identified for the general population or females of reproductive age.

Chronic Dietary all populations NOAEL= 20 mg/ kg/ day UF = 100 Chronic RfD = 0.2 mg/ kg/ day FQPA SF = 1x cPAD = cRfD ÷ FQPA SF = 0.2 mg/ kg/ day Combined chronic toxicity/ carcinogenicity  rat LOAEL = 80 mg/ kg/ day, based on increases in severity of chronic progressive glomerulonephropathy in the males and minimal decreases in body weight and body weight gain in both sexes.

Cancer Not likely to be carcinogenic to humans, based on the lack of evidence of carcinogenicity in rats and mice.

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 6 of 15 VI. Results/ Discussion As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of the cPAD. The DEEM FCID   analyses estimate the dietary exposure of the U. S. population and various population subgroups. The results reported in Table 4 are for the general U. S. Population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, females 13 49, adults 20 49, and adults 50+ years.

Quinoxyfen chronic dietary ( food + water) exposure estimates using the DEEM FCID   software are well below HED's level of concern for the U. S. population and each of the population subgroups. Dietary exposure was estimated at 0.002596 mg/ kg/ day for the U. S. population ( 1.3% of the cPAD) and 0.003923 mg/ kg/ day ( 2.0% of the cPAD) for the most highly exposed population subgroup ( children, 1 2 years old). The estimated exposures/ risks for food, drinking water and combined food and water are summarized in Table 4 for all populations.

Table 4. Summary of Chronic Dietary Exposure and Risk for Quinoxyfen1 Food Only Drinking Water Only Total Population Subgroup Exposure ( mg/ kg/ day) % cPAD Exposure ( mg/ kg/ day) % cPAD Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.002420 1.2 0.000176 0.1 0.002596 1.3 All Infants (< 1 year old) 0.000784 0.4 0.000577 0.3 0.001361 0.7 Children 1 2 years old 0.003662 1.8 0.000261 0.1 0.003923 2.0 Children 3 5 years old 0.003294 1.6 0.000245 0.1 0.003539 1.8 Children 6 12 years old 0.002390 1.2 0.000169 0.1 0.002559 1.3 Youth 13 19 years old 0.002062 1.0 0.000127 0.1 0.002189 1.1 Adults 20 49 years old 0.002486 1.2 0.000164 0.1 0.002651 1.3 Adults 50+ years old 0.002234 1.1 0.000173 0.1 0.002407 1.2 Females 13 49 years old 0.002571 1.3 0.000164 0.1 0.002734 1.4 1The population subgroup with the highest estimated chronic dietary ( food + drinking water) exposure and risk is indicated by bold text.

VII. Characterization of Inputs/ Outputs These chronic dietary exposure and risk estimates are conservative since they assume that 100% of crops are treated with quinoxyfen and that residues are present at tolerance levels. In addition, drinking water exposure estimates were based on screening level estimates generated by the PRZM EXAMS model. Dietary exposure estimates could be refined through the use of anticipated residues and percent crop treated data, as well as refined estimated drinking water Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 7 of 15 concentrations. However, since estimated exposures and risks using conservative assumptions are well below HED's level of concern, such refinement is not warranted.

VIII. Conclusions This Tier 1 chronic dietary exposure analysis using DEEM FCID   indicates that chronic dietary exposure to quinoxyfen from food and drinking water is well below HED's level of concern for this pesticide. Estimated chronic dietary exposures are less than or equal to 2% of the cPAD for the general U. S. population and all population subgroups.

IX. List of Attachments Chronic Food Only Input File Chronic Food Only Results File Chronic Drinking Water Only Input File Chronic Drinking Water Only Results File Chronic Food + Drinking Water Input File Chronic Food + Drinking Water Results File Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 8 of 15 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for QUNIOXYFEN 1994 98 data Residue file: C:\ Documents and Settings\ sstanton\ My Documents\ DEEM FCID Files\ Quinoxyfen\ Quinoxyfen food only. R98 Adjust. # 2 NOT used Analysis Date 04 13 2006 Residue file dated: 04 13 2006/ 14: 15: 10/ 8 Reference dose ( RfD) = 0.2 mg/ kg bw/ day Comment: Chronic dietary assessment ( FOOD ONLY) to support new uses on lettuce, strawberry, pepper & melons.  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        09010750 9A Cantaloupe 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 09010800 9A Casaba 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 12000900 12 Cherry 0.300000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 12000901 12 Cherry babyfood 0.300000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 12000910 12 Cherry, juice 0.300000 1.500 1.000 Establ Full comment: Established Permanent Tolerance 12000911 12 Cherry, juice babyfood 0.300000 1.500 1.000 Establ Full comment: Established Permanent Tolerance 95001750 O Grape 0.600000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 95001760 O Grape, juice 0.600000 1.200 1.000 Establ Full comment: Established Permanent Tolerance 95001761 O Grape, juice babyfood 0.600000 1.200 1.000 Establ Full comment: Established Permanent Tolerance 95001770 O Grape, leaves 0.600000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 95001780 O Grape, raisin 0.600000 4.300 1.000 Establ Full comment: Established Permanent Tolerance 95001790 O Grape, wine and sherry 0.600000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 09011870 9A Honeydew melon 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 95001880 O Hop 3.000000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 04012040 4A Lettuce, head 7.000000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 04012050 4A Lettuce, leaf 19.000000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002700 8 Pepper, bell 0.350000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002701 8 Pepper, bell babyfood 0.350000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002710 8 Pepper, bell, dried 0.350000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002711 8 Pepper, bell, dried babyfood 0.350000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002720 8 Pepper, nonbell 1.700000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002721 8 Pepper, nonbell babyfood 1.700000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 9 of 15 08002730 8 Pepper, nonbell, dried 1.700000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 09023080 9B Pumpkin 0.300000 1.000 1.000 Sec. 1 Full comment: Sec. 18. Expires 12/ 31/ 07 09023090 9B Pumpkin, seed 0.300000 1.000 1.000 Sec. 1 Full comment: Sec. 18. Expires 12/ 31/ 07 09023570 9B Squash, winter 0.300000 1.000 1.000 Sec. 1 Full comment: Sec. 18. Expires 12/ 31/ 07 09023571 9B Squash, winter babyfood 0.300000 1.000 1.000 Sec. 1 Full comment: Sec. 18. Expires 12/ 31/ 07 95003590 O Strawberry 0.900000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 95003591 O Strawberry babyfood 0.900000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 95003600 O Strawberry, juice 0.900000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 95003601 O Strawberry, juice babyfood 0.900000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 09013990 9A Watermelon 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 09014000 9A Watermelon, juice 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 10 of 15 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for QUNIOXYFEN ( 1994 98 data) Residue file name: C:\ Documents and Settings\ sstanton\ My Documents\ DEEM FCID Files\ Quinoxyfen\ Quinoxyfen food only. R98 Adjustment factor # 2 NOT used. Analysis Date 04 13 2006/ 14: 15: 58 Residue file dated: 04 13 2006/ 14: 15: 10/ 8 Reference dose ( RfD, Chronic) = .2 mg/ kg bw/ day COMMENT 1: Chronic dietary assessment ( FOOD ONLY) to support new uses on lettuce, strawberry, pepper & melons. =============================================================================== Total exposure by population subgroup  Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population ( total) 0.002420 1.2%

U. S. Population ( spring season) 0.002537 1.3% U. S. Population ( summer season) 0.002435 1.2% U. S. Population ( autumn season) 0.002321 1.2% U. S. Population ( winter season) 0.002394 1.2%

Northeast region 0.002541 1.3% Midwest region 0.002484 1.2% Southern region 0.002080 1.0% Western region 0.002782 1.4%

Hispanics 0.002286 1.1% Non hispanic whites 0.002592 1.3% Non hispanic blacks 0.001521 0.8% Non hisp/ non white/ non black 0.002476 1.2%

All infants (< 1 year) 0.000784 0.4% Nursing infants 0.000354 0.2% Non nursing infants 0.000947 0.5% Children 1 6 yrs 0.003287 1.6% Children 7 12 yrs 0.002367 1.2%

Females 13 19 ( not preg or nursing) 0.002069 1.0% Females 20+ ( not preg or nursing) 0.002540 1.3% Females 13 50 yrs 0.002542 1.3% Females 13+ ( preg/ not nursing) 0.002881 1.4% Females 13+ ( nursing) 0.002636 1.3%

Males 13 19 yrs 0.002023 1.0% Males 20+ yrs 0.002234 1.1% Seniors 55+ 0.002166 1.1%

Children 1 2 yrs 0.003662 1.8% Children 3 5 yrs 0.003294 1.6% Children 6 12 yrs 0.002390 1.2% Youth 13 19 yrs 0.002062 1.0% Adults 20 49 yrs 0.002486 1.2% Adults 50+ yrs 0.002234 1.1% Females 13 49 yrs 0.002571 1.3% Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 11 of 15 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for QUNIOXYFEN 1994 98 data Residue file: C:\ Documents and Settings\ sstanton\ My Documents\ DEEM FCID Files\ Quinoxyfen\ Quinoxyfen water only. R98 Adjust. # 2 NOT used Analysis Date 04 13 2006 Residue file dated: 04 13 2006/ 14: 45: 10/ 8 Reference dose ( RfD) = 0.2 mg/ kg bw/ day Comment: Quinoxyfen Drinking Water Chronic Assessment.  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        86010000 O Water, direct, all sources 0.008350 1.000 1.000 EFED M Full comment: EFED Memo of 3/ 23/ 2006 86020000 O Water, indirect, all sources 0.008350 1.000 1.000 EFED M Full comment: EFED Memo of 3/ 23/ 2006 Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 12 of 15 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for QUNIOXYFEN ( 1994 98 data) Residue file name: C:\ Documents and Settings\ sstanton\ My Documents\ DEEM FCID Files\ Quinoxyfen\ Quinoxyfen water only. R98 Adjustment factor # 2 NOT used. Analysis Date 04 13 2006/ 14: 45: 57 Residue file dated: 04 13 2006/ 14: 45: 10/ 8 Reference dose ( RfD, Chronic) = .2 mg/ kg bw/ day COMMENT 1: Quinoxyfen Drinking Water Chronic Assessment. =============================================================================== Total exposure by population subgroup  Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population ( total) 0.000176 0.1%

U. S. Population ( spring season) 0.000174 0.1% U. S. Population ( summer season) 0.000189 0.1% U. S. Population ( autumn season) 0.000170 0.1% U. S. Population ( winter season) 0.000170 0.1%

Northeast region 0.000161 0.1% Midwest region 0.000178 0.1% Southern region 0.000167 0.1% Western region 0.000202 0.1%

Hispanics 0.000200 0.1% Non hispanic whites 0.000172 0.1% Non hispanic blacks 0.000167 0.1% Non hisp/ non white/ non black 0.000216 0.1%

All infants (< 1 year) 0.000577 0.3% Nursing infants 0.000214 0.1% Non nursing infants 0.000715 0.4% Children 1 6 yrs 0.000246 0.1% Children 7 12 yrs 0.000160 0.1%

Females 13 19 ( not preg or nursing) 0.000124 0.1% Females 20+ ( not preg or nursing) 0.000176 0.1% Females 13 50 yrs 0.000170 0.1% Females 13+ ( preg/ not nursing) 0.000171 0.1% Females 13+ ( nursing) 0.000244 0.1%

Males 13 19 yrs 0.000129 0.1% Males 20+ yrs 0.000158 0.1% Seniors 55+ 0.000173 0.1%

Children 1 2 yrs 0.000261 0.1% Children 3 5 yrs 0.000245 0.1% Children 6 12 yrs 0.000169 0.1% Youth 13 19 yrs 0.000127 0.1% Adults 20 49 yrs 0.000164 0.1% Adults 50+ yrs 0.000173 0.1% Females 13 49 yrs 0.000164 0.1% Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 13 of 15 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for QUNIOXYFEN 1994 98 data Residue file: C:\ Documents and Settings\ sstanton\ My Documents\ DEEM FCID Files\ Quinoxyfen\ Quinoxyfen. R98 Adjust. # 2 NOT used Analysis Date 04 12 2006 Residue file dated: 04 12 2006/ 09: 04: 14/ 8 Reference dose ( RfD) = 0.2 mg/ kg bw/ day Comment: Chronic dietary assessment to support new uses on lettuce, strawberry, pepper & melons.  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        09010750 9A Cantaloupe 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 09010800 9A Casaba 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 12000900 12 Cherry 0.300000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 12000901 12 Cherry babyfood 0.300000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 12000910 12 Cherry, juice 0.300000 1.500 1.000 Establ Full comment: Established Permanent Tolerance 12000911 12 Cherry, juice babyfood 0.300000 1.500 1.000 Establ Full comment: Established Permanent Tolerance 95001750 O Grape 0.600000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 95001760 O Grape, juice 0.600000 1.200 1.000 Establ Full comment: Established Permanent Tolerance 95001761 O Grape, juice babyfood 0.600000 1.200 1.000 Establ Full comment: Established Permanent Tolerance 95001770 O Grape, leaves 0.600000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 95001780 O Grape, raisin 0.600000 4.300 1.000 Establ Full comment: Established Permanent Tolerance 95001790 O Grape, wine and sherry 0.600000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 09011870 9A Honeydew melon 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 95001880 O Hop 3.000000 1.000 1.000 Establ Full comment: Established Permanent Tolerance 04012040 4A Lettuce, head 7.000000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 04012050 4A Lettuce, leaf 19.000000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002700 8 Pepper, bell 0.350000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002701 8 Pepper, bell babyfood 0.350000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002710 8 Pepper, bell, dried 0.350000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002711 8 Pepper, bell, dried babyfood 0.350000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002720 8 Pepper, nonbell 1.700000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 08002721 8 Pepper, nonbell babyfood 1.700000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 14 of 15 08002730 8 Pepper, nonbell, dried 1.700000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 09023080 9B Pumpkin 0.300000 1.000 1.000 Sec. 1 Full comment: Sec. 18. Expires 12/ 31/ 07 09023090 9B Pumpkin, seed 0.300000 1.000 1.000 Sec. 1 Full comment: Sec. 18. Expires 12/ 31/ 07 09023570 9B Squash, winter 0.300000 1.000 1.000 Sec. 1 Full comment: Sec. 18. Expires 12/ 31/ 07 09023571 9B Squash, winter babyfood 0.300000 1.000 1.000 Sec. 1 Full comment: Sec. 18. Expires 12/ 31/ 07 95003590 O Strawberry 0.900000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 95003591 O Strawberry babyfood 0.900000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 95003600 O Strawberry, juice 0.900000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 95003601 O Strawberry, juice babyfood 0.900000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 86010000 O Water, direct, all sources 0.008350 1.000 1.000 EFED M Full comment: EFED Memo of 3/ 23/ 2006 86020000 O Water, indirect, all sources 0.008350 1.000 1.000 EFED M Full comment: EFED Memo of 3/ 23/ 2006 09013990 9A Watermelon 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use 09014000 9A Watermelon, juice 0.080000 1.000 1.000 Pendin Full comment: Pending Tolerance for New Use Quinoxyfen Dietary Exposure and Risk Assessment DP Number: 328363 PC Code: 055459 ______________________________________________________________________________________

Page 15 of 15 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for QUNIOXYFEN ( 1994 98 data) Residue file name: C:\ Documents and Settings\ sstanton\ My Documents\ DEEM FCID Files\ Quinoxyfen\ Quinoxyfen. R98 Adjustment factor # 2 NOT used. Analysis Date 04 12 2006/ 09: 12: 23 Residue file dated: 04 12 2006/ 09: 04: 14/ 8 Reference dose ( RfD, Chronic) = .2 mg/ kg bw/ day COMMENT 1: Chronic dietary assessment to support new uses on lettuce, strawberry, pepper & melons. =============================================================================== Total exposure by population subgroup  Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population ( total) 0.002596 1.3%

U. S. Population ( spring season) 0.002711 1.4% U. S. Population ( summer season) 0.002624 1.3% U. S. Population ( autumn season) 0.002491 1.2% U. S. Population ( winter season) 0.002565 1.3%

Northeast region 0.002702 1.4% Midwest region 0.002662 1.3% Southern region 0.002248 1.1% Western region 0.002984 1.5%

Hispanics 0.002485 1.2% Non hispanic whites 0.002764 1.4% Non hispanic blacks 0.001688 0.8% Non hisp/ non white/ non black 0.002692 1.3%

All infants (< 1 year) 0.001361 0.7% Nursing infants 0.000568 0.3% Non nursing infants 0.001662 0.8% Children 1 6 yrs 0.003533 1.8% Children 7 12 yrs 0.002527 1.3%

Females 13 19 ( not preg or nursing) 0.002193 1.1% Females 20+ ( not preg or nursing) 0.002716 1.4% Females 13 50 yrs 0.002712 1.4% Females 13+ ( preg/ not nursing) 0.003052 1.5% Females 13+ ( nursing) 0.002879 1.4%

Males 13 19 yrs 0.002153 1.1% Males 20+ yrs 0.002391 1.2% Seniors 55+ 0.002339 1.2%

Children 1 2 yrs 0.003923 2.0% Children 3 5 yrs 0.003539 1.8% Children 6 12 yrs 0.002559 1.3% Youth 13 19 yrs 0.002189 1.1% Adults 20 49 yrs 0.002651 1.3% Adults 50+ yrs 0.002407 1.2% Females 13 49 yrs 0.002734 1.4%