[Federal Register: May 28, 2009 (Volume 74, Number 101)]
[Rules and Regulations]
[Page 25394-25396]
[DOCID:fr28my09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0482; Directorate Identifier 2008-SW-54-AD;
Amendment 39-15920; AD 2009-11-10]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland GmbH Model EC135
Helicopters

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter Deutschland GmbH (Eurocopter) Model EC135 helicopters. This
AD results from a report of abnormal main rotor blade vibrations on a
Eurocopter Model EC135 helicopter. This AD also results from mandatory
continuing airworthiness information (MCAI) issued by the European
Aviation Safety Agency (EASA), which is the Technical Agent for the
Member States of the European Community. The MCAI states that an
operator reported unusual vibrations during the start phase of the main
rotor blade on one helicopter. The vibrations stopped after the
application of torque. Subsequent maintenance personnel found that six
of the eight attachment screws of the lower hub-shaft bearing support
were loose. This condition was discovered in two additional
helicopters. Loose screws in the bearing support, if not detected and
corrected, could result in abnormal main rotor blade vibrations and
subsequent damage to the main transmission.

DATES: This AD becomes effective on June 12, 2009.
    The incorporation by reference of certain publications is approved
by the Director of the Federal Register as of June 12, 2009.
    We must receive comments on this AD by July 27, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, TX
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://
www.eurocopter.com.
    Examining the Docket: You may examine the AD docket on the Internet
at http://www.regulations.gov or in person at the Docket Operations
office between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the economic evaluation, any
comments received, and other information. The street address for the
Docket Operations office (telephone<PHONE_NUMBER>) is stated in the
ADDRESSES section of this AD. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Chinh Vuong, Aviation Safety Engineer,
FAA, Rotorcraft Directorate, Safety Management Group, Fort Worth, Texas
76193-0111, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We recently received a report of abnormal main rotor blade
vibration on a Eurocopter Model EC135 helicopter. This main rotor blade
vibration occurred after initial aircraft start, while operating at
flat pitch, between 8.5 and 25 percent torque and 98.6 percent NR/N2
speed, and dissipated once the FADEC switches were advanced to FLIGHT.
The main rotor transmission chip light also illuminated with minimal
debris found on the chip detectors. During troubleshooting, six of the
eight main transmission lower hub-shaft bearing support bolts were
found lying in the bottom of the main transmission case, atop of the
lower transmission access panel. Only two of the eight bolts remained
installed, loose in their positions, and the outer race of the roller
bearing was rotated out of position (cocked). Approximately three weeks
after that first incident, we received a report that loose bolts were
discovered on two additional newer helicopters that had not been
inspected at the time the loose bolts were discovered on the first
helicopter. Subsequent investigations revealed that screws were not
properly torqued and vibrations had caused the screws to back-out.
Loosened screws in the bearing support, if not detected and corrected,
could result in abnormal main rotor blade vibrations and subsequent
damage to the main transmission.
    EASA has issued EASA Emergency AD 2008-0175-E, dated September 16,
2008, to correct an unsafe condition for the Eurocopter Model EC135
helicopters. The MCAI explains that ``The lower hub-shaft bearing
consists of a ball bearing and a roller bearing. The outer race of the
roller bearing is fixed to the housing with screws. Should all
attachment screws become loose, the outer race of the roller bearing
might separate, which would constitute an unsafe condition. In such
case, however, the axial guidance of the rotor hub-shaft would still be
ensured.'' The MCAI requires inspecting the main transmission
attachment hardware and installing locking washers. You may obtain
further information by examining the MCAI and any related service
information in the AD docket.

Related Service Information

    Eurocopter has issued Alert Service Bulletin EC135-63A-013,
Revision 2, dated September 12, 2008 (ASB). The ASB specifies checking
the screws at the lower hub-shaft bearing for correct attachment and
securing attachment hardware by means of locking washers. The actions
described in the MCAI are intended to correct the same unsafe condition
as that identified in the service information.

FAA's Evaluation and Unsafe Condition Determination

    This product has been approved by the aviation authority of
Germany, and is approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, their Technical Agent,
has notified us of the unsafe condition described in the MCAI. We are
issuing this AD because we evaluated all information provided by EASA
and determined the unsafe condition exists and is likely to exist or
develop on other helicopters of the same type design.

Differences Between This AD and the MCAI AD

    This AD does not require sending the main transmission to the
manufacturer and does not refer to the transmission part numbers. Also,
this AD uses the term ``hours time-in-service'', the MCAI AD uses the
term ``flight cycles''.

Costs of Compliance

    We estimate that this AD will affect about 189 helicopters of U.S.
registry. We also estimate that it will take about 8 work-hours to
inspect and install lock washers, at an average labor rate of $80 per
work-hour. Required parts will cost about $574 per helicopter ($86 for
the lock washers and $488 for the required oil). Based on these
figures, we estimate the cost of this AD on U.S. operators will be
$229,446 ($1,214 per helicopter).

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. We find that the risk to the flying public justifies waiving
notice and comment prior to adoption of this rule because loosened
screws in the bearing support, if not detected and corrected quickly,
could result in abnormal main rotor blade vibrations and subsequent
damage to the main transmission. Therefore, we have determined that
notice and opportunity for public comment before issuing this AD are
impracticable and that good cause exists for making this amendment
effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. However, we invite you to send us any written data, views, or
arguments concerning this AD. Send your comments to an address listed
under the ADDRESSES section of this AD. Include ``Docket No. FAA-2009-
0482; Directorate Identifier 2008-SW-54-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on product(s) identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    Therefore, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2009-11-10 Eurocopter Deutschland GmbH: Amendment 39-15920. Docket
No. FAA-2009-0482; Directorate Identifier 2008-SW-54-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective on June
12, 2009.

Other Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Eurocopter Deutschland GmbH (Eurocopter)
Model EC135 helicopters with a main transmission with a serial
number of 0001 through 1420 and 1500 through 1749 installed,
certificated in any category.

Reason

    (d) The mandatory continuing airworthiness information (MCAI)
states that an operator reported unusual vibrations during the start
phase of the main rotor blade on one helicopter. The vibrations
stopped after the application of torque. Subsequently, maintenance
personnel found that six of the eight attachment screws of the lower
hub-shaft bearing support were loose. This condition was discovered
in two additional helicopters. Loose screws in the bearing support,
if not detected and corrected, could result in abnormal main rotor
blade vibrations and subsequent damage to the main transmission.

Actions and Compliance

    (e) Within 3 hours time-in-service (TIS) if unusual vibrations
are detected during the start phase or the shutdown phase when the
main rotors are not at full operation RPM, or within 50 hours TIS
after the effective date of this AD, whichever occurs first, do the
following:
    (1) Remove the lower transmission cover.

    Note 1: You may drain the oil into a clean container so that it
can be reused.

    (2) Measure the clearance between the outer race and the
transmission housing at four positions offset by 90[deg] using a
feeler gauge as depicted in Figure 1 of Eurocopter

Alert Service Bulletin EC135-63A-013, Revision 02, dated September
12, 2008 (ASB). If the measured maximum clearance is:
    (i) Less than or equal to 0.1 mm--install locking washers,
tighten all screws, and re-measure the clearance by following
paragraphs 3.B.(3) through 3.B.(7) of the ASB.
    (ii) More than 0.1 mm--determine the difference between the
smallest and the largest clearance and:
    (A) If the difference is less than 0.4 mm--install locking
washers, tighten all screws, and re-measure the clearance by
following paragraphs 3.B.(2) through 3.B.(7) of the ASB.
    (B) If the difference is equal to or more than 0.4 mm--replace
the transmission before further flight with an airworthy
transmission that has been modified in accordance with paragraph
3.B. of the ASB.
    (iii) If the re-measured clearances obtained in accordance with
paragraphs (e)(2)(i) or (e)(2)(ii)(A) of this AD are not less than
or equal to 0.05 mm, replace the transmission with an airworthy
transmission that has been modified in accordance with paragraph
3.B. of the ASB.
    (3) Reinstall the lower transmission cover and replenish the
transmission oil.

    Note 2: If the transmission oil was drained into a clean
container, it can be reused. Also, if the O-ring on the lower
transmission cover is not damaged, it can be reused once.

    (f) After the effective date of this AD, install only main
transmissions that have been modified in accordance with paragraph
3.B.(3) of the ASB.

Differences Between This AD and the MCAI AD

    (g) This AD does not require sending the main transmission to
the manufacturer and does not refer to the transmission part
numbers. Also, this AD uses the term ``hours time-in-service'', the
MCAI AD uses the term ``flight cycles''.

Other Information

    (h) The Manager, Safety Management Group, FAA, ATTN: Chinh
Vuong, Aviation Safety Engineer, FAA, Rotorcraft Directorate, Safety
Management Group, Fort Worth, Texas 76193-0111, telephone (817) 222-
5116, fax<PHONE_NUMBER> has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19.

Related Information

    (i) European Aviation Safety Agency (EASA) MCAI Emergency AD No.
2008-0175-E, dated September 16, 2008, contains related information.

Air Transport Association of America (ATA) Tracking Code

    (j) ATA Code 63: Main rotor drive.

Material Incorporated by Reference

    (k) You must use the specified portions of Eurocopter Alert
Service Bulletin EC135-63A-013, Revision 02, dated September 12,
2008, to do the actions required.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, TX
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at
http://www.eurocopter.com.
    (3) You may review copies at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas; or at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas on May 19, 2009.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
 [FR Doc. E9-12319 Filed 5-27-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57584]
[DOCID:fr03oc05-79]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP93-117-004]

San Diego Gas & Electric Company; Notice of Application for
Amended Section 3 Authorizations and Presidential Permit

September 23, 2005.
    Take notice that on September 13, 2005, San Diego Gas & Electric
Company (SDGE), 8330 Century Park Court, San Diego, CA 92123, filed in
Docket No. CP93-117-004 an application pursuant to Section 3 of the
Natural Gas Act (NGA) and part 153 of the Federal Energy Regulatory
Commission's (Commission) regulations, for an order amending previous
authorization and Presidential Permit for the siting, construction, and
operation of pipeline and metering facilities for the export and import
of natural gas at the International Boundary between the United States
and Mexico in San Diego County, California. In this application, SDGE
seeks authorization to make minor modifications to these facilities to
increase the maximum capacity from 350 MMcf of gas per day to 800 MMcf
of gas per day, all as more fully set forth in the application which is
on file with the Commission and open to public inspection. This filing
is available for review at the Commission in the Public Reference Room.
This filing also may be viewed on the Commission's Web site at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,

contact<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Georgetta J. Baker, Sempra Energy, at<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the below listed comment date, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157. 10) by the
comment date below. A person obtaining party status will be placed on
the service list maintained by the Secretary of the Commission and will
receive copies of all documents filed by the applicant and by all other
parties. A party must submit 14 copies of filings made with the
Commission and must mail a copy to the applicant and to every other
party in the proceeding. Only parties to the proceeding can ask for
court review of Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.
    Comment Date: October 14, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5363 Filed 9-30-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Pages 32284-32288]
[FR Doc No: 2014-12943]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0278; FRL-9911-16]

Registration Review Proposed and Proposed Interim Decisions;
Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed
registration review decisions and opens a public comment period on the
proposed and proposed interim decisions. Registration review is EPA's
periodic review of pesticide registrations to ensure that each
pesticide continues to satisfy the statutory standard for registration,
that is, that the pesticide can perform its intended function without
unreasonable adverse effects on human health or the environment.
Through this program, EPA is ensuring that each pesticide's
registration is based on current scientific and other knowledge,
including its effects on human health and the environment. This
document also announces the registration review case closure for the
pesticide amitrole (case 0095) and the availability of the amitrole
case closure document. The cancellation of all amitrole product
registrations became effective on April 11, 2014. This case closure for
amitrole is being announced herein with no comment period.

DATES: Comments must be received on or before August 4, 2014.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in the table in Unit II.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: The Chemical Review Manager for the pesticide of interest
identified in the table in Unit II.A.
    For general information on the registration review program,
contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-8015; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all

the specific entities that may be affected by this action. If you have
any questions regarding the applicability of this action to a
particular entity, consult the Chemical Review Manager for the
pesticide of interest identified in the table in Unit II.A.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed and proposed interim registration review decisions
for the pesticides shown in the following table, and opens a 60-day
public comment period on the proposed and proposed interim decisions.
Ancymidol (Proposed Interim Decision)
    The registration review docket for ancymidol (EPA-HQ-OPP-2011-0482)
opened in June 2011. Ancymidol is a plant growth regulator registered
for treating container-grown herbaceous plants, ornamental woody
shrubs, and bedding plants grown in greenhouses and in outdoor plant-
bedding areas. It is also registered for use as a seed treatment for
ornamental plants, and treated seeds are used to start plants. Use of
ancymidol is limited to nursery grown ornamentals. There are no food,
feed, or residential uses registered for ancymidol. No pesticide
tolerances have been established. EPA conducted a qualitative
assessment for both human health and ecological risks. No risks of
concern were identified in the human health risk assessment. The
ecological risk assessment indicated that there was no reasonable
expectation for any registered use of ancymidol to cause direct or
indirect adverse effects to threatened and endangered species. A ``no
effect'' determination was made for all federally listed species and
designated critical habitat. Ancymidol has not been evaluated under the
Endocrine Disruptor Screening Program (EDSP). Therefore, the Agency's
final registration review decision is dependent upon the result of the
evaluation of potential endocrine disruptor risk. Pending the outcome
of this action, EPA is planning to issue an interim registration review
decision for ancymidol.
DEET (Combined Work Plan and Proposed Interim Decision)
    The registration review docket for DEET (N,N-diethyl-meta-
toulamide) is opening (EPA-HQ-OPP-2012-0162) for public comment on a
combined Work Plan and Proposed Interim Registration Review Decision.
DEET is a broad-spectrum insect repellent registered for use against
biting flies, biting midges, black flies, chiggers, deer flies, fleas,
gnats, horse flies, mosquitoes, no-see-ums, sand flies, stable flies,
and ticks. It is currently registered for non-food uses and residential
uses. It can be directly used on clothing, applied to the skin, and
used on horses. EPA conducted a qualitative assessment for both human
health and environmental fate and ecological risks. No risks of concern
were identified. The ecological risk assessment made a ``no effect''
determination for federally listed species and designated critical
habitat. DEET has not been evaluated under the EDSP. Therefore, the
Agency's final registration review decision is dependent upon the
result of the evaluation of potential endocrine disruptor risk. Pending
the outcome of this action, EPA is planning to issue an interim
registration review decision for DEET.
Denatonium Saccharide (Proposed Interim Decision)
    The registration review docket for denatonium saccharide (EPA-HQ-
OPP-2008-0441) opened in June 2008. Denatonium saccharide is a
bittering agent in squirrel, vole, dog, and cat repellents used on
outdoor surfaces and structures such as trees, fences, poles, decks,
planters, siding, garbage cans, furniture, seeds, and bulbs. EPA
conducted a qualitative human health risk assessment and did not
identify any risks of concern. The ecological risk assessment
identified potential risks for birds and listed mammals. However, due
to the number of conservative assumptions included in the assessment,
the Agency is not proposing mitigation changes at this time. The risk
assessment for denatonium saccharide did not come to a conclusion of
``no effect'' to listed species. Therefore, consultation with the U.S.
Fish and Wildlife Service (USFWS) on the potential risk of denatonium
saccharide to listed species will be necessary. Denatonium saccharide
has not been evaluated under the EDSP. Therefore, the Agency's final
registration review decision is dependent upon the result of Section 7
Endangered Species consultation with the USFWS and the evaluation of
potential endocrine disruptor risk. Pending the outcome of these
actions, EPA is planning to issue an interim registration review
decision for denatonium saccharide.
Dioctyl Sodium Sulfosuccinate (Proposed Decision)
    The registration review docket for DSS (EPA-HQ-OPP-2010-1006)
opened in December 2010. DSS is registered as an insecticide and
miticide in pet shampoos and spray products in combination with
Undecylenic Acid (UDA). As a pesticidal active ingredient, there are no
food uses and, thus, no tolerances are established. DSS is used as an
active ingredient in over the counter stool-softener and laxative
products for infants, children, and adults; it is also used in
pharmaceutical, cosmetic, and food products. EPA has conducted a
qualitative assessment for both human health and ecological risks,
including listed species for DSS. The human health risk assessment did
not

identify any risks of concern for DSS. The ecological risk assessment
made a ``no effect'' determination for federally listed species and
designated critical habitat. Pursuant to FFDCA Section 408(p)(4), EPA
has exempted DSS from the requirements of the EDSP in an Administrative
Order entitled Exemption of Dioctyl Sodium Sulfosuccinate (DSS) and
Undecylenic Acid (UDA) from the Requirements of the Endocrine Disruptor
Screening Program which is available in the registration review docket.
Gas Cartridges; Inorganic Nitrate--Nitrite, Carbon and Carbon Dioxide,
and Sulfur (Proposed Interim Decision)
    Potassium and sodium nitrate, carbon and carbon dioxide, and sulfur
are ingredients in fumigant gas cartridge products, which are available
in small and large sizes. Both sizes are registered to control
burrowing mammals, but only the large gas cartridge is registered to
also control coyotes, red foxes and skunks. Gas cartridges are
registered for outdoor use only. To use the products, the user lights
the fuse, places the cartridge in the burrow or den and seals the
entrance. Animals within the burrow or den are asphyxiated by the
release of carbon dioxide and toxic gases.
    The Agency relied on a previous human health risk assessment in
making its registration review decisions and determined that no human
health risks of concern exist for these compounds. The Agency conducted
a new ecological risk assessment for the gas cartridges for
registration review. The risk assessment did find the potential for
adverse effects to a number of endangered species from gas cartridge
use. EPA developed mitigation to address the risk to a number of the
endangered species. In most cases, the mitigation involves the use of
Endangered Species Protection Bulletins. Because the gas cartridges
contain the three compounds, these Bulletins are available for comment
in the Inorganic Nitrate--Nitrite, Carbon and Carbon Dioxide, and
Sulfur Registration Review dockets (EPA-HQ-OPP-2007-1118, EPA-HQ-OPP-
2007-0705, and EPA-HQ-OPP-2008-0176, respectively). Although
implementation of these Bulletins will address risk to some endangered
species from gas cartridge use, risk to a number of other endangered
species remains. Additionally, potassium and sodium nitrate, carbon and
carbon dioxide, and sulfur have not been evaluated under the EDSP.
Therefore, the Agency's final registration review decisions are
dependent upon the result of Section 7 Endangered Species consultation
with the USFWS and the evaluation of potential endocrine disruptor
risk. Pending the outcome of these actions, EPA is planning to issue
interim registration review decisions for sodium and potassium nitrate,
carbon and carbon dioxide, and sulfur.
Metofluthrin (Proposed Interim Decision)
    The registration review docket for metofluthrin (EPA-HQ-OPP-2012-
0105) opened in June 2013. Metofluthrin is a Type 1 synthetic
pyrethroid insect repellent and insecticide with products registered
for use in residential and commercial areas, including barns, patios,
porches, campgrounds, stables and kennels to repel adult mosquitoes and
kill bed bugs. The products registered for outdoor use are an
impregnated paper repellent strip, a battery-operated personal outdoor
insect repellent fan, an impregnated fiberglass ring heated by a
candle, and battery-operated automated mister. The registered indoor
use is a soluble concentrate used as a spray to kill bedbugs. There are
no registered food/feed uses for metofluthrin. No pesticide tolerances
have been established. EPA conducted a human health risk assessment and
an ecological risk assessment. No risks of concern were identified in
the human health risk assessment. The ecological risk assessment
indicated that there was no reasonable expectation for any registered
use of metofluthrin to cause direct or indirect adverse effects to
threatened and endangered species. A ``no effect'' determination was
made for all federally listed species and designated critical habitat.
Metofluthrin has not been evaluated under the EDSP. Therefore, the
Agency's final registration review decision is dependent upon the
result of the evaluation of potential endocrine disruptor risk. Pending
the outcome of this action, EPA is planning to issue an interim
registration review decision for metofluthrin.
Polybutene Resins (Proposed Decision)
    The registration review docket for polybutene resins (EPA-HQ-OPP-
2009-0649) opened in June 2010. Polybutene is a sticky polymer
registered for use as a bird and small mammal repellent. It is used to
prevent house sparrows, pigeons, and starlings from roosting inside and
outside of buildings, as well as to prevent beavers from attacking
trees and shrubs. There are no food/feed uses and, it is exempt from a
tolerance requirement when used as a sticker agent in packaging of
insect control products used on food crops. Polybutene is approved by
the U.S. Food and Drug Administration (FDA) as an indirect food
additive and is used as an ingredient in cosmetic products that are
applied directly to the skin such as sun block or moisturizer, and that
may be incidentally ingested, such as lipstick. EPA conducted a
qualitative assessment for both human health and environmental fate and
ecological risks. No risks of concern were identified in the human
health risk assessment. The ecological risk assessment indicated that
there was no reasonable expectation for any registered use of
polybutene to cause direct or indirect adverse effects to threatened
and endangered species. A ``no effect'' determination was made for all
federally listed species and designated critical habitat. Pursuant to
FFDCA Section 408(p)(4), EPA has exempted polybutene from the
requirements of the EDSP in an Administrative Order (AO) entitled
Exemption of Polybutene from the Requirements of the Endocrine
Disruptor Screening Program. The AO is available in the registration
review docket.
Sulfur (Proposed Interim Decision)
    The registration review docket for sulfur (EPA-HQ-OPP-2008-0176)
opened in March 2008. Sulfur is used as an insecticide and fungicide on
a wide range of field and greenhouse-grown food and feed crops,
livestock, livestock quarters, and indoor and outdoor residential
sites. Sulfur is also registered for use in gas cartridge products,
along with inorganic nitrate/nitrite, carbon, and carbon dioxide. EPA
has conducted a qualitative assessment for both human health and
ecological risks, including listed species for sulfur. Details of the
assessment for the gas cartridge use are summarized under the gas
cartridge heading in this unit. For uses of sulfur other than gas
cartridges, the Agency is making a ``no effect'' determination for all
listed aquatic species, and a ``no effect'' determination for direct
effects to listed terrestrial vertebrates that do not rely on insects
as a primary food source. However, at this time, the Agency is not able
to make an endangered species determination on terrestrial
invertebrates, terrestrial plants, or indirect effects to terrestrial
vertebrates with insects as a primary food source. Sulfur has not been
evaluated under the EDSP. Therefore, the Agency's final registration
review decision is dependent upon the result of Section 7 Endangered
Species consultation with the USFWS and the evaluation of potential
endocrine disruptor risk. Pending the outcome of these actions, EPA is
planning to issue

an interim registration review decision for sulfur.
Undecylenic Acid (Proposed Decision)
    The registration review docket for UDA (EPA-HQ-OPP-2011-0910)
opened in December 2011. UDA is registered as an insecticide and
miticide in pet shampoos and spray products in combination with dioctyl
sodium sulfosuccinate (DSS). As a pesticidal active ingredient, there
are no food uses and, thus, no tolerances are established. UDA is
approved by the FDA as an active ingredient in over the counter anti-
fungal products, and it is also used as a flavoring agent. EPA has
conducted a qualitative assessment for both human health and ecological
risks, including listed species for UDA. The human health risk
assessment did not identify any risks of concern for UDA. The
ecological risk assessment made a ``no effect'' determination for
federally listed species and designated critical habitat. Pursuant to
FFDCA Section 408(p)(4), EPA has exempted UDA from the requirements of
the EDSP in an AO entitled Exemption of Dioctyl Sodium Sulfosuccinate
(DSS) and Undecylenic Acid (UDA) from the Requirements of the Endocrine
Disruptor Screening Program which is available in the registration
review docket.
    This notice also announces the registration review case closure for
the pesticide amitrole (case 0095) and the availability of the amitrole
case closure document. The Notice of Receipt of a Request to
Voluntarily Cancel Certain Pesticide Registrations was issued in the
Federal Register of August 28, 2013 (78 FR 53141)(FRL-9396-4), and no
substantive public comments were received during the 180-day comment
period that impacted the Agency's decision to grant the cancellation
request. In the Federal Register of April 11, 2014 (79 FR 20199) (FRL-
9908-31), the Agency published the Cancellation Order for all amitrole
product registrations. Due to the cancellation of all registered
amitrole products in the United States, the Agency closed the
registration review case for amitrole, pursuant to 40 CFR 155.42(c). In
addition to the registration review case closure document, the
registration review docket (EPA-HQ-OPP-2011-0105) for amitrole, also
includes other relevant documents related to the registration review of
this case. This action is not open for public comment.

                    Table--Registration Review Proposed and Proposed Interim Final Decisions
----------------------------------------------------------------------------------------------------------------
 Registration review case name and                                 Chemical review manager,  telephone number,
                No.                   Pesticide Docket ID No.                     email address
----------------------------------------------------------------------------------------------------------------
Ancymidol (Case 3017)....  EPA-HQ-OPP-2011-0482......  Christina Scheltema,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Carbon and Carbon Dioxide (Case     EPA-HQ-OPP-2007-0705......  Carissa Cyran,
 4019).<PHONE_NUMBER>,
<EMAIL_ADDRESS>DEET (N,N-diethyl-meta-toulamide)   EPA-HQ-OPP-2012-0162......  Susan Bartow,
 (Case 0002).<PHONE_NUMBER>,
<EMAIL_ADDRESS>Denatonium Saccharide (Case 7625).<PHONE_NUMBER>,
<EMAIL_ADDRESS>Dioctyl Sodium Sulfosuccinate       EPA-HQ-OPP-2010-1006......  Garland Waleko,
 (Case 4029).<PHONE_NUMBER>,
<EMAIL_ADDRESS>Inorganic Nitrate--Nitrite (Case    EPA-HQ-OPP-2007-1118......  Eric Miederhoff,
 4052).<PHONE_NUMBER>,
<EMAIL_ADDRESS>Metofluthrin (Case 7445)..........  EPA-HQ-OPP-2012-0105......  Veronica Dutch,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Polybutene Resins (Case 4076).<PHONE_NUMBER>,
<EMAIL_ADDRESS>Sulfur (Case 0031).......  EPA-HQ-OPP-2008-0176......  Tanja Crk,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Undecylenic Acid (Case 4095).<PHONE_NUMBER>,
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------

    The registration review docket for a pesticide includes earlier
documents related to the registration review of the case. For example,
the review opened with a Summary Document, containing a Preliminary
Work Plan, for public comment. A Final Work Plan was placed in the
docket following public comment on the initial docket.
    The documents in the dockets describe EPA's rationales for
conducting additional risk assessments for the registration review of
the pesticides included in the table in Unit II.A., as well as the
Agency's subsequent risk findings and consideration of possible risk
mitigation measures. These proposed and proposed interim registration
review decisions are supported by the rationales included in those
documents.
    Following public comment, the Agency will issue final registration
review decisions or interim registration review decisions for products
containing the pesticides listed in the table in Unit II.A.
    The registration review program is being conducted under
congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. Section 3(g) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) required
EPA to establish by regulation procedures for reviewing pesticide

registrations, originally with a goal of reviewing each pesticide's
registration every 15 years to ensure that a pesticide continues to
meet the FIFRA standard for registration. The Agency's final rule to
implement this program was issued in August 2006 and became effective
in October 2006, and appears at 40 CFR part 155, subpart C. The
Pesticide Registration Improvement Act of 2003 (PRIA) was amended and
extended in September 2007. FIFRA, as amended by PRIA in 2007, requires
EPA to complete registration review decisions by October 1, 2022, for
all pesticides registered as of October 1, 2007.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed registration
review decisions. This comment period is intended to provide an
opportunity for public input and a mechanism for initiating any
necessary amendments to the proposed decision. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
docket for the pesticides included in the table in Unit II.A. Comments
received after the close of the comment period will be marked ``late.''
EPA is not required to consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a ``Response to Comments Memorandum'' in
the docket. The final registration review decision will explain the
effect that any comments had on the decision and provide the Agency's
response to significant comments.
    Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier
documents related to the registration review of these pesticides are
provided at:  http://www.epa.gov/oppsrrd1/registration_review/reg_review_status.htm.

B. What is the Agency's authority for taking this action?

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide
authority for this action.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Pesticides and pests, Ancymidol, Amitrole, Carbon and Carbon Dioxide,
DEET, Denatonium Saccharide, Dioctyl Sodium Sulfosuccinate, Inorganic
Nitrate--Nitrite, Metofluthrin, Polybutene Resins, Sulfur, and
Undecylenic Acid.

    Dated: May 28, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2014-12943 Filed 6-3-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21558-21559]
[FR Doc No: 2016-08329]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0560]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Informed
Consent for In Vitro Diagnostic Device Studies Using Leftover Human
Specimens

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 12,
2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0582.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance on Informed Consent for In Vitro Diagnostic Device Studies
Using Leftover Human Specimens That Are Not Individually Identifiable--
OMB Control Number 0910-0582--Extension

    FDA's investigational device regulations are intended to encourage
the development of new, useful devices in a manner that is consistent
with public health, safety, and compliant with ethical standards.
Investigators should have freedom to pursue the least burdensome means
of accomplishing this goal. However, to ensure that the balance is
maintained between product

development and the protection of public health, safety, and ethical
standards, FDA has established human subject protection regulations
addressing requirements for informed consent and institutional review
board (IRB) review that apply to all FDA-regulated clinical
investigations involving human subjects. In particular, informed
consent requirements further both safety and ethical considerations by
allowing potential subjects to consider both the physical and privacy
risks they face if they agree to participate in a trial.
    Under FDA regulations, clinical investigations using human
specimens conducted in support of premarket submissions to FDA are
considered human subject investigations (see 21 CFR 812.3(p)). Many
investigational device studies are exempt from most provisions of part
812, Investigational Device Exemptions, under 21 CFR 812.2(c)(3), but
FDA's regulations for the protection of human subjects (21 CFR parts 50
and 56) apply to all clinical investigations that are regulated by FDA
(see 21 CFR 50.1, 21 CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and 21 U.S.C.
360j(g)(3)(D)).
    FDA regulations do not contain exceptions from the requirements of
informed consent on the grounds that the specimens are not identifiable
or that they are remnants of human specimens collected for routine
clinical care or analysis that would otherwise have been discarded. Nor
do FDA regulations allow IRBs to decide whether or not to waive
informed consent for research involving leftover or unidentifiable
specimens.
    In a level 1 guidance document, entitled ``Guidance on Informed
Consent for In Vitro Diagnostic Device Studies Using Leftover Human
Specimens that are Not Individually Identifiable,'' issued under the
Good Guidances Practices regulation, 21 CFR 10.115, FDA outlines the
circumstances in which it intends to exercise enforcement discretion as
to the informed consent regulations for clinical investigators,
sponsors, and IRBs.
    The recommendations of the guidance impose a minimal burden on
industry. FDA estimates that 700 studies will be affected annually.
Each study will result in one annual record, estimated to take 4 hours
to complete. This results in a total recordkeeping burden of 2,800
hours (700 x 4 = 2,800).
    In the Federal Register of October 23, 2015 (80 FR 64422), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                        The FD&C Act section                            Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(g).............................................................             700                1              700                4            2,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08329 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P


   SEQ CHAPTER \h \r 1

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	8-JUNE-2007

SUBJECT:	Pyrasulfotole.  Acute and Chronic Dietary Exposure and Risk Assessments for Section 3 Registration on Small Cereal Grains.  DP# 333435.  Decision # 366490.  Chemical: 000692.

FROM/TO:	Jennifer R. Tyler, Chemist

		Registration Action Branch (RAB1)

		Health Effects Division (HED) (7509C)

THROUGH:	PV Shah, Ph.D., Branch Senior Scientist

RAB1/HED (7509C)

				and

		David Hrdy, Sr. Biologist

		Christina Swartz, Chemist

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

Executive Summary

Acute and chronic dietary (food and drinking water) exposure analyses were requested in order to determine the dietary exposure estimates associated with the HED-recommended tolerances for residues of the herbicide pyrasulfotole in/on small cereal grains and livestock commodities.  No cancer dietary exposure assessment was performed because pyrasulfotole is not carcinogenic.

An unrefined, acute dietary exposure assessment was performed for the general U.S. population and all other population subgroups (including infants and children) using tolerance-level residues and assuming 100% crop treated (CT) for all proposed uses.  Drinking water was incorporated directly into the dietary assessment using the acute concentration for surface water generated by the FQPA Index Reservoir Screening Tool (FIRST) model.  The results of this assessment indicate that the acute dietary exposure estimates (95th percentile) are below HED’s level of concern [<100% of the acute Population Adjusted Dose (aPAD)] for the general U.S. population (2% of the aPAD) and all other populations subgroups.  The most highly exposed population subgroup is children 1-2 years old at 4% of the cPAD.

An unrefined, chronic dietary exposure assessment was performed for the general U.S. population and various population subgroups using tolerance-level residues and assuming 100% CT for all proposed uses.  Drinking water was incorporated directly into the dietary assessment using the chronic concentration for surface water generated by the FIRST model.  The results of the assessment concludes that the chronic dietary exposure estimates are below HED’s level of concern [<100% of the chronic Population Adjusted Dose (cPAD)] for the general U.S. population (2% of the cPAD) and all population subgroups.  The most highly exposed population subgroup is children 1-2 years old at 7% of the cPAD.

Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose.  This is the PAD, which HED has concluded will result in no unreasonable adverse health effects.  The PAD is the reference dose (RfD) divided by the FQPA 10x Safety Factor.  Dietary risk is expressed as a percentage of the PAD.  HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References which discuss the acute and 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:   HYPERLINK "http://www.epa.gov/fedrgstr/"  http://www.epa.gov/fedrgstr/  EPA_PEST/2000/July/Day_12/6061.pdf; or see SOP 99.6 (8/20/99).  The current acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, Version 2.03).  This is the first dietary exposure assessment for pyrasulfotole.

Residue Information

Proposed Tolerances:  The available residue chemistry database supports the establishment of permanent tolerances for the combined residues of pyrasulfotole and pyrasulfotole-desmethyl in/on the following raw agricultural and livestock commodities:

Wheat, grain	0.02 ppm	Cattle, liver	0.35 ppm

Wheat, straw	0.20 ppm	Goat, meat	0.02 ppm

Wheat, forage	0.20 ppm	Goat, fat	0.02 ppm

Wheat, hay	0.80 ppm	Goat, meat byproducts, except liver	0.06 ppm

Aspirated grain fractions	0.40 ppm	Goat, liver	0.35 ppm

Oat, grain	0.08 ppm	Sheep, meat	0.02 ppm

Oat, straw	0.20 ppm	Sheep, fat	0.02 ppm

Oat, forage	0.10 ppm	Sheep, meat byproducts, except liver	0.06 ppm

Oat, hay	0.50 ppm	Sheep, liver	0.35 ppm

Barley, grain	0.02 ppm	Horse, meat byproducts, except liver	0.05 ppm

Barley, straw	0.20 ppm	Horse, liver	0.30 ppm

Barley, hay	0.30 ppm	Hog, meat	0.02 ppm

Rye, grain	0.02 ppm	Hog, fat	0.02 ppm

Rye, straw	0.20 ppm	Hog, meat byproducts	0.02 ppm

Rye, forage	0.20 ppm	Poultry, meat	0.02 ppm

Milk	0.01 ppm	Poultry, fat	0.02 ppm

Cattle, meat	0.02 ppm	Poultry, meat byproducts	0.02 ppm

Cattle, fat	0.02 ppm	Eggs	0.02 ppm

Cattle, meat byproducts, except liver	0.06 ppm

Nature of the Residue:

Plants:  Based on the results of the wheat metabolism studies, pyrasulfotole and pyrasulfotole-desmethyl are the residues of concern for tolerances and risk assessment purposes (Memo, J. Tyler et al., 06/08/07; D328640).  This conclusion applies only to the use of pyrasulfotole on small cereal grains.  Any future uses on other crops, such as leafy vegetables, or legumes, may require the submission of additional metabolism data.

Livestock:  Based on the results of the dairy cattle and laying hen metabolism studies, the residues of concern in livestock for tolerance and risk assessment purposes are parent and the desmethyl metabolite (Memo, J. Tyler et al., 06/08/07; D328640).

Drinking Water:  The residues of concern in drinking water for risk assessment purposes are parent only (Memo, J. Tyler et al., 06/08/07; D328640).

Drinking Water Considerations:  The Environmental Fate and Effects Division (EFED) provided Estimated Drinking Water Concentrations (EDWCs) of pyrasulfotole in surface and ground water using the FIRST and Screening Concentration in Ground Water (SCI-GROW) models, respectively.  The assessment was based on the proposed small cereal grain use, which has a maximum proposed seasonal application rate of 0.045 lb ai/A.  EFED calculated the 1- in 10-year peak acute and 1- in 10-year estimated annual mean non-cancer chronic EDWCs for pyrasulfotole in surface water to be 4.0 ppb and 2.8 ppb, respectively.  The ground water EDWC for both acute and chronic exposures in estimated as 1.4 ppb.

Percent Crop Treated:  For the acute and chronic assessments, it was assumed that 100% of the proposed crops have been treated with pyrasulfotole.

Residue and PDP Data:  HED-recommended tolerance level residues were used for all proposed commodities in the acute and chronic assessments.

Processing Factors:  The results of the wheat processing study indicate that residues of pyrasulfotole and pyrasulfotole-desmethyl do not appear to concentrate in wheat flour (0.26x), middling (0.38x), shorts (0.56x) and germ (0.70x).  Total residues of pyrasulfotole and pyrasulfotole-desmethyl do appear to concentrate in aspirated wheat grain fractions (33x), and wheat bran (1.6x).  Based on these processing factors and a highest-average field trial (HAFT) residue of 0.011 ppm from the wheat field trials, a separate tolerance is not needed for wheat, bran, but a tolerance should be established for aspirated grain fractions at 0.40 ppm.  In addition, based on the results of the processed food/feed data on wheat, HED concludes that residues of pyrasulfotole and pyrasulfotole-desmethyl are not expected to concentrate in pearled barley, barley flour, oat flour, groats/rolled oats, and rye flour.  Therefore, tolerances on these processed commodities are not needed.  Because the results of the processing study indicate that residues concentrated in wheat bran, residues can be expected to concentrate in barley bran, oat bran and rye bran as well.  Based on the 1.6x processing factor for wheat bran, and a HAFT residue of 0.010 ppm from the barley field trials, the maximum expected residues in barley bran would be 0.016 ppm, which is below the recommended 0.02 ppm tolerance for barley, grain.  Therefore, a separate tolerance is not needed for barley, bran.  Based on the 1.6x processing factor for wheat bran, and a HAFT residue of 0.109 ppm from the oat field trials, the maximum expected residues in oat bran would be 0.17 ppm, which is above the recommended 0.08 ppm tolerance for oat, grain.  Therefore, a separate tolerance should be established for oat, bran at 0.20 ppm.  However, according to current HED guidelines, HED does not currently set tolerances on oat, bran.  The residue level will be incorporated into the dietary exposure assessment.  Based on the 1.6x processing factor for wheat bran, and a HAFT residue of 0.011 ppm from the wheat field trials, the maximum expected residues in rye bran would be 0.018 ppm, which is below the recommended 0.02 ppm tolerance for rye, grain.  Therefore, a separate tolerance is not needed for wheat, bran.

DEEM-FCID™ Program and Consumption Information

The pyrasulfotole acute and chronic dietary exposure assessments were conducted using DEEM-FCID™ (Version 2.03), which incorporates consumption data from USDA’s CSFII, 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  Consumption data are averaged for the entire U.S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

For chronic exposure and risk assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form.  The resulting residue consumption estimate for each food/food form is summed with the residue consumption 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.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic (Tier 1 or Tier 2) exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic (Tier 3/4) assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for Tiers 1 and 2, significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment.

Toxicological Information

A summary of the toxicological doses and endpoints selected for dietary exposure assessment is provided in Table 1.

Table 1.  Summary of Toxicological Doses and Endpoints for Pyrasulfotole for Use in Dietary Human Health Risk Assessments.

Exposure Scenario	Point of Departure	Uncertainty/FQPA Safety Factors RfD, PAD, Level of Concern for Risk Assessment	Study and Relevant Toxicological Effects

Acute Dietary (All populations)	NOAEL = 3.8

mg/kg/day	UFA = 10X

UFH = 10X

UFFQPA = 1X 	aRfD = aPAD = 0.038 mg/kg/day	Developmental neurotoxicity (rat; dietary) Offspring LOAEL = 37 mg/kg/day based on delayed preputial separation (males), decreased cerebrum length (PND 21 females), and decreased cerebellum height (PND 21 males)

Chronic Dietary (All populations)	NOAEL = 1.0

mg/kg/day	UFA = 10X

UFH = 10X

UFFQPA = 1X	cRfD = cPAD = 0.01mg/kg/day	Combined chronic toxicity/carcinogenicity (rat; dietary) LOAEL = 10/14 mg/kg/day (M/F) based on corneal opacity, neovascularization of the cornea, inflammation of the cornea, regenerative corneal hyperplasia, corneal atrophy, and/or retinal atrophy (both sexes), and hepatocellular hypertrophy along with increased serum cholesterol (males)

Cancer (oral, dermal, inhalation)	Classification:  “Suggestive Evidence of Carcinogenic Potential” based on increased incidences of corneal tumors in male rats (carcinogenicity study) and urinary bladder tumors in male and female mice (carcinogenicity study)

1  UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation in sensitivity among members of the human population (intraspecies), UFFQPA = FQPA Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose (a = acute, c = chronic), PAD = population adjusted dose.

Results/Discussion/Conclusions

-FCID™ analysis estimates the dietary exposure of the U.S. population and 26 population subgroups.  The results reported in Table 2 are for the U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, males 20-49, and adults 50+ years.

An acute dietary exposure assessment (using tolerance level residues and 100% CT information for all proposed uses) was conducted for the general U.S. population and various population subgroups (including infants and children).  Drinking water was incorporated directly in the dietary assessments using the acute concentration for surface water generated by the FIRST model.  The results of the acute assessment indicate that the acute dietary exposure estimates (95th percentile) are below HED’s level of concern (<100% of the aPAD) for the general U.S. population (2% of the aPAD) and all populations subgroups.  The most highly exposed population subgroup is children 1-2 years old at 4% of the cPAD.

The chronic dietary exposure assessment (using tolerance level residues and 100% CT information for all proposed uses) was conducted for the general U.S. population and various population subgroups.  Drinking water was incorporated directly into the dietary assessment using the chronic concentration for surface water generated by the FIRST model.  The results of the chronic assessment indicate that the chronic dietary exposure estimates are below HED’s level of concern (<100% of the cPAD) for the general U.S. population (2% of the cPAD) and all population subgroups.  The most highly exposed population subgroup is children 1-2 years old at 7% of the cPAD.

Table 2.  Summary of Dietary Exposure and Risk for Pyrasulfotole.

Population

Subgroup	Acute Dietary1	Chronic Dietary2

	Dietary Exposure

(mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD

U.S. Population (total)	0.000633	2	0.000224	2

All Infants (< 1 year old)	0.001259	3	0.000410	4

Children 1-2 years old	0.001393	4	0.000698	7

Children 3-5 years old	0.001053	3	0.000541	5

Children 6-12 years old	0.000691	2	0.000339	3

Youth 13-19 years old	0.000431	1	0.000190	2

Adults 20-49 years old	0.000378	1	0.000168	2

Adults 50+ years old	0.000331	1	0.000160	2

Females 13-49 years old	0.000368	1	0.000161	2

1 Acute dietary endpoint of 0.038 mg/kg/day applies to the general U.S. population and all population subgroups.

2 Chronic dietary endpoint of 0.01 mg/kg/day applies to the general U.S. population and all population subgroups.

List of Attachments

ute DEEM-FCID™ Analysis – All Populations.

Attachment 2.  Acute DEEM-FCID™ Analysis – All Populations.

Attachment 3:  Residue File for Chronic DEEM-FCID™ Analysis.

Attachment 4:  Chronic DEEM-FCID™ Analysis.

cc (w/ Attachments): J. Tyler, T. White (RD, 7505P); D. Kenny (RD; 7505P)

RDI: DE SAC [C. Swartz (5/30/07), D. Hrdy (5/23/07)]; G. Kramer (06/08/07)

J.Tyler:S-10943:(703)305-5564: 7509C:RAB1

Attachment 1.  Residue File for Acute DEEM-FCID™ Analysis – All Populations.

Filename: C:\Documents and Settings\jtyler\My Documents\JenWork\$Pyrasulfatole\DEEM\000692a.R98

Chemical: Pyrasulfotole

RfD(Chronic): .01 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): .038 mg/kg bw/day  NOEL(Acute):  3.8 mg/kg bw/day

Date created/last modified: 06-06-2007/13:33:06/8          Program ver. 2.03

Comment: Proposed use on small cereal grains.  FQPA Safety Factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

15000250 15   Barley, pearled barley             0.020000   1.000  1.000

15000251 15   Barley, pearled barley-babyfood    0.020000   1.000  1.000

15000260 15   Barley, flour                      0.020000   1.000  1.000

15000261 15   Barley, flour-babyfood             0.020000   1.000  1.000

15000270 15   Barley, bran                       0.020000   1.000  1.000

21000440 M    Beef, meat                         0.020000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.020000   1.000  1.000

21000450 M    Beef, meat, dried                  0.020000   1.000  1.000

21000460 M    Beef, meat byproducts              0.060000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.060000   1.000  1.000

21000470 M    Beef, fat                          0.020000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.020000   1.000  1.000

21000480 M    Beef, kidney                       0.060000   1.000  1.000

21000490 M    Beef, liver                        0.350000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.350000   1.000  1.000

40000930 P    Chicken, meat                      0.020000   1.000  1.000

40000931 P    Chicken, meat-babyfood             0.020000   1.000  1.000

40000940 P    Chicken, liver                     0.020000   1.000  1.000

40000950 P    Chicken, meat byproducts           0.020000   1.000  1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.020000   1.000  1.000

40000960 P    Chicken, fat                       0.020000   1.000  1.000

40000961 P    Chicken, fat-babyfood              0.020000   1.000  1.000

40000970 P    Chicken, skin                      0.020000   1.000  1.000

40000971 P    Chicken, skin-babyfood             0.020000   1.000  1.000

70001450 P    Egg, whole                         0.020000   1.000  1.000

70001451 P    Egg, whole-babyfood                0.020000   1.000  1.000

70001460 P    Egg, white                         0.020000   1.000  1.000

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000  1.000

70001470 P    Egg, yolk                          0.020000   1.000  1.000

70001471 P    Egg, yolk-babyfood                 0.020000   1.000  1.000

23001690 M    Goat, meat                         0.020000   1.000  1.000

23001700 M    Goat, meat byproducts              0.060000   1.000  1.000

23001710 M    Goat, fat                          0.020000   1.000  1.000

23001720 M    Goat, kidney                       0.060000   1.000  1.000

23001730 M    Goat, liver                        0.350000   1.000  1.000

24001890 M    Horse, meat                        0.020000   1.000  1.000

28002210 M    Meat, game                         0.020000   1.000  1.000

27002220 D    Milk, fat                          0.010000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.010000   1.000  1.000

27012230 D    Milk, nonfat solids                0.010000   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.010000   1.000  1.000

27022240 D    Milk, water                        0.010000   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.010000   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.010000   1.000  1.000

15002310 15   Oat, bran                          0.200000   1.000  1.000

15002320 15   Oat, flour                         0.080000   1.000  1.000

15002321 15   Oat, flour-babyfood                0.080000   1.000  1.000

15002330 15   Oat, groats/rolled oats            0.080000   1.000  1.000

15002331 15   Oat, groats/rolled oats-babyfood   0.080000   1.000  1.000

25002900 M    Pork, meat                         0.020000   1.000  1.000

25002901 M    Pork, meat-babyfood                0.020000   1.000  1.000

25002910 M    Pork, skin                         0.020000   1.000  1.000

25002920 M    Pork, meat byproducts              0.020000   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.020000   1.000  1.000

25002930 M    Pork, fat                          0.020000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.020000   1.000  1.000

25002940 M    Pork, kidney                       0.020000   1.000  1.000

25002950 M    Pork, liver                        0.020000   1.000  1.000

60003010 P    Poultry, other, meat               0.020000   1.000  1.000

60003020 P    Poultry, other, liver              0.020000   1.000  1.000

60003030 P    Poultry, other, meat byproducts    0.020000   1.000  1.000

60003040 P    Poultry, other, fat                0.020000   1.000  1.000

60003050 P    Poultry, other, skin               0.020000   1.000  1.000

29003120 M    Rabbit, meat                       0.020000   1.000  1.000

15003280 15   Rye, grain                         0.020000   1.000  1.000

15003290 15   Rye, flour                         0.020000   1.000  1.000

26003390 M    Sheep, meat                        0.020000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.020000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.060000   1.000  1.000

26003410 M    Sheep, fat                         0.020000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.020000   1.000  1.000

26003420 M    Sheep, kidney                      0.060000   1.000  1.000

26003430 M    Sheep, liver                       0.350000   1.000  1.000

15003810 15   Triticale, flour                   0.020000   1.000  1.000

15003811 15   Triticale, flour-babyfood          0.020000   1.000  1.000

50003820 P    Turkey, meat                       0.020000   1.000  1.000

50003821 P    Turkey, meat-babyfood              0.020000   1.000  1.000

50003830 P    Turkey, liver                      0.020000   1.000  1.000

50003831 P    Turkey, liver-babyfood             0.020000   1.000  1.000

50003840 P    Turkey, meat byproducts            0.020000   1.000  1.000

50003841 P    Turkey, meat byproducts-babyfood   0.020000   1.000  1.000

50003850 P    Turkey, fat                        0.020000   1.000  1.000

50003851 P    Turkey, fat-babyfood               0.020000   1.000  1.000

50003860 P    Turkey, skin                       0.020000   1.000  1.000

50003861 P    Turkey, skin-babyfood              0.020000   1.000  1.000

86010000 O    Water, direct, all sources         0.004000   1.000  1.000  4.0 pp

          Full comment: 4.0 ppb surface water EDWC

86020000 O    Water, indirect, all sources       0.004000   1.000  1.000  4.0 pp

          Full comment: 4.0 ppb surface water EDWC

15004010 15   Wheat, grain                       0.020000   1.000  1.000

15004011 15   Wheat, grain-babyfood              0.020000   1.000  1.000

15004020 15   Wheat, flour                       0.020000   1.000  1.000

15004021 15   Wheat, flour-babyfood              0.020000   1.000  1.000

15004030 15   Wheat, germ                        0.020000   1.000  1.000

15004040 15   Wheat, bran                        0.020000   1.000  1.000

Attachment 2.  Acute DEEM-FCID™ Analysis – General U.S. Population, Including Infants and Children.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for PYRASULFOTOLE                       (1994-98 data)

Residue file: 000692a.R98                         Adjustment factor #2 NOT used.

Analysis Date: 06-06-2007/13:34:48    Residue file dated: 06-06-2007/13:33:06/8

NOEL (Acute) =   3.800000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Proposed use on small cereal grains.  FQPA Safety Factor=1x; the

refore, aRfD=aPAD and cRfD=cPAD."

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE

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

U.S. Population:

  0.000633    1.67    6005    0.001039    2.74    3655    0.001747    4.60    2175

All infants:

  0.001259    3.31    3018    0.001913    5.04    1985    0.002750    7.24    1382

Children 1-2 yrs:

  0.001393    3.67    2727    0.001847    4.86    2057    0.002698    7.10    1408

Children 3-5 yrs:

  0.001053    2.77    3610    0.001434    3.77    2649    0.002675    7.04    1420

Children 6-12 yrs:

  0.000691    1.82    5502    0.000922    2.43    4119    0.001358    3.57    2797

Youth 13-19 yrs:

  0.000431    1.13    8818    0.000635    1.67    5981    0.001056    2.78    3600

Adults 20-49 yrs:

  0.000378    0.99   10060    0.000535    1.41    7096    0.000885    2.33    4292

Adults 50+ yrs:

  0.000331    0.87   11476    0.000439    1.15    8664    0.000966    2.54    3933

Females 13-49 yrs:

  0.000368    0.97   10330    0.000518    1.36    7340    0.000888    2.34    4277

FCID™ Analysis.

Filename: C:\Documents and Settings\jtyler\My Documents\JenWork\$Pyrasulfatole\DEEM\000692c.R98

Chemical: Pyrasulfotole

RfD(Chronic): .01 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): .038 mg/kg bw/day  NOEL(Acute):  3.8 mg/kg bw/day

Date created/last modified: 06-06-2007/13:33:53/8          Program ver. 2.03

Comment:  Proposed use on small cereal grains.  FQPA safety factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

15000250 15   Barley, pearled barley             0.020000   1.000  1.000

15000251 15   Barley, pearled barley-babyfood    0.020000   1.000  1.000

15000260 15   Barley, flour                      0.020000   1.000  1.000

15000261 15   Barley, flour-babyfood             0.020000   1.000  1.000

15000270 15   Barley, bran                       0.020000   1.000  1.000

21000440 M    Beef, meat                         0.020000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.020000   1.000  1.000

21000450 M    Beef, meat, dried                  0.020000   1.000  1.000

21000460 M    Beef, meat byproducts              0.060000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.060000   1.000  1.000

21000470 M    Beef, fat                          0.020000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.020000   1.000  1.000

21000480 M    Beef, kidney                       0.060000   1.000  1.000

21000490 M    Beef, liver                        0.350000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.350000   1.000  1.000

40000930 P    Chicken, meat                      0.020000   1.000  1.000

40000931 P    Chicken, meat-babyfood             0.020000   1.000  1.000

40000940 P    Chicken, liver                     0.020000   1.000  1.000

40000950 P    Chicken, meat byproducts           0.020000   1.000  1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.020000   1.000  1.000

40000960 P    Chicken, fat                       0.020000   1.000  1.000

40000961 P    Chicken, fat-babyfood              0.020000   1.000  1.000

40000970 P    Chicken, skin                      0.020000   1.000  1.000

40000971 P    Chicken, skin-babyfood             0.020000   1.000  1.000

70001450 P    Egg, whole                         0.020000   1.000  1.000

70001451 P    Egg, whole-babyfood                0.020000   1.000  1.000

70001460 P    Egg, white                         0.020000   1.000  1.000

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000  1.000

70001470 P    Egg, yolk                          0.020000   1.000  1.000

70001471 P    Egg, yolk-babyfood                 0.020000   1.000  1.000

23001690 M    Goat, meat                         0.020000   1.000  1.000

23001700 M    Goat, meat byproducts              0.060000   1.000  1.000

23001710 M    Goat, fat                          0.020000   1.000  1.000

23001720 M    Goat, kidney                       0.060000   1.000  1.000

23001730 M    Goat, liver                        0.350000   1.000  1.000

24001890 M    Horse, meat                        0.020000   1.000  1.000

28002210 M    Meat, game                         0.020000   1.000  1.000

27002220 D    Milk, fat                          0.010000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.010000   1.000  1.000

27012230 D    Milk, nonfat solids                0.010000   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.010000   1.000  1.000

27022240 D    Milk, water                        0.010000   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.010000   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.010000   1.000  1.000

15002310 15   Oat, bran                          0.200000   1.000  1.000

15002320 15   Oat, flour                         0.080000   1.000  1.000

15002321 15   Oat, flour-babyfood                0.080000   1.000  1.000

15002330 15   Oat, groats/rolled oats            0.080000   1.000  1.000

15002331 15   Oat, groats/rolled oats-babyfood   0.080000   1.000  1.000

25002900 M    Pork, meat                         0.020000   1.000  1.000

25002901 M    Pork, meat-babyfood                0.020000   1.000  1.000

25002910 M    Pork, skin                         0.020000   1.000  1.000

25002920 M    Pork, meat byproducts              0.020000   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.020000   1.000  1.000

25002930 M    Pork, fat                          0.020000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.020000   1.000  1.000

25002940 M    Pork, kidney                       0.020000   1.000  1.000

25002950 M    Pork, liver                        0.020000   1.000  1.000

60003010 P    Poultry, other, meat               0.020000   1.000  1.000

60003020 P    Poultry, other, liver              0.020000   1.000  1.000

60003030 P    Poultry, other, meat byproducts    0.020000   1.000  1.000

60003040 P    Poultry, other, fat                0.020000   1.000  1.000

60003050 P    Poultry, other, skin               0.020000   1.000  1.000

29003120 M    Rabbit, meat                       0.020000   1.000  1.000

15003280 15   Rye, grain                         0.020000   1.000  1.000

15003290 15   Rye, flour                         0.020000   1.000  1.000

26003390 M    Sheep, meat                        0.020000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.020000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.060000   1.000  1.000

26003410 M    Sheep, fat                         0.020000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.020000   1.000  1.000

26003420 M    Sheep, kidney                      0.060000   1.000  1.000

26003430 M    Sheep, liver                       0.350000   1.000  1.000

15003810 15   Triticale, flour                   0.020000   1.000  1.000

15003811 15   Triticale, flour-babyfood          0.020000   1.000  1.000

50003820 P    Turkey, meat                       0.020000   1.000  1.000

50003821 P    Turkey, meat-babyfood              0.020000   1.000  1.000

50003830 P    Turkey, liver                      0.020000   1.000  1.000

50003831 P    Turkey, liver-babyfood             0.020000   1.000  1.000

50003840 P    Turkey, meat byproducts            0.020000   1.000  1.000

50003841 P    Turkey, meat byproducts-babyfood   0.020000   1.000  1.000

50003850 P    Turkey, fat                        0.020000   1.000  1.000

50003851 P    Turkey, fat-babyfood               0.020000   1.000  1.000

50003860 P    Turkey, skin                       0.020000   1.000  1.000

50003861 P    Turkey, skin-babyfood              0.020000   1.000  1.000

86010000 O    Water, direct, all sources         0.002800   1.000  1.000  2.8 pp

          Full comment: 2.8 ppb surface water EDWC

86020000 O    Water, indirect, all sources       0.002800   1.000  1.000  2.8 pp

          Full comment: 2.8 ppb surface water EDWC

15004010 15   Wheat, grain                       0.020000   1.000  1.000

15004011 15   Wheat, grain-babyfood              0.020000   1.000  1.000

15004020 15   Wheat, flour                       0.020000   1.000  1.000

15004021 15   Wheat, flour-babyfood              0.020000   1.000  1.000

15004030 15   Wheat, germ                        0.020000   1.000  1.000

15004040 15   Wheat, bran                        0.020000   1.000  1.000

:  Chronic DEEM-FCID™ Analysis.

U.S. Environmental Protection Agency                                 Ver. 2.00

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

Residue file name: C:\Documents and Settings\jtyler\My Documents\JenWork\$Pyrasulfatole\DEEM\000692c.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 06-06-2007/13:35:21     Residue file dated: 06-06-2007/13:33:53/8

Reference dose (RfD, Chronic) = .01 mg/kg bw/day

COMMENT 1: Proposed use on small cereal grains.  FQPA safety factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

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U.S. Population (spring season)             0.000222                 2.2%

U.S. Population (summer season)             0.000224                 2.2%

U.S. Population (autumn season)             0.000227                 2.3%

U.S. Population (winter season)             0.000221                 2.2%

Northeast region                            0.000221                 2.2%

Midwest region                              0.000233                 2.3%

Southern region                             0.000209                 2.1%

Western region                              0.000239                 2.4%

Hispanics                                   0.000255                 2.6%

Non-hispanic whites                         0.000218                 2.2%

Non-hispanic blacks                         0.000222                 2.2%

Non-hisp/non-white/non-black                0.000246                 2.5%

All infants (< 1 year)                      0.000410                 4.1%

Nursing infants                             0.000155                 1.6%

Non-nursing infants                         0.000506                 5.1%

Children 1-6  yrs                           0.000580                 5.8%

Children 7-12 yrs                           0.000318                 3.2%

Females 13-19 (not preg or nursing)         0.000166                 1.7%

Females 20+ (not preg or nursing)           0.000158                 1.6%

Females 13-50 yrs                           0.000177                 1.8%

Females 13+ (preg/not nursing)              0.000192                 1.9%

Females 13+ (nursing)                       0.000227                 2.3%

Males 13-19 yrs                             0.000211                 2.1%

Males 20+ yrs                               0.000172                 1.7%

Seniors 55+                                 0.000160                 1.6%

Children 1-2 yrs                            0.000698                 7.0%

Children 3-5 yrs                            0.000541                 5.4%

Children 6-12 yrs                           0.000339                 3.4%

Youth 13-19 yrs                             0.000190                 1.9%

Adults 20-49 yrs                            0.000168                 1.7%

Adults 50+ yrs                              0.000160                 1.6%

Females 13-49 yrs                           0.000161                 1.6%

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

 PAGE   14

Page   PAGE  1  of   NUMPAGES  13


M E M O R A N D U M
To:   		Docket EPA-R09-OAR-2012-0713, Docket EPA- R09-OAR-2012-0721
From: 		Wienke Tax, EPA Region IX, Air Planning Office
Date:		September 14, 2012
Concerning:  	EPA Proposed Rules, Finding of Substantial Inadequacy of Implementation Plan; Call for California State Implementation Plan Revision; South Coast, and Disapproval of Implementation Plan Revisions; State of California; South Coast VMT Emissions Offset Demonstrations - Conference Call Notes, Conference Call, September 14, 2012.
_____________________________
On Friday, September 14, 2012, EPA Region 9 staff and managers Elizabeth Adams, Jefferson Wehling, Jeanhee Hong, Carol Bohnenkamp, Karina O'Connor, and Wienke Tax participated in a conference call with staff and managers from the South Coast Air Quality Management District (SCAQMD) Elaine Chang, Henry Hogo, Joseph Cassmassi, Philip Fine, Barbara Baird, Bill Wong, and Laki Tisopulos. The purpose of the conference call was to discuss EPA's proposals regarding the 1-hour ozone SIP call for South Coast, and the requirement for the South Coast to submit new VMT emission offset demonstrations for 1-hour and 8-hour ozone. SCAQMD staff also clarified that they will be submitting a status update on the implementation of their approved 8-hour ozone plan.

In connection with the 1-hour ozone SIP call, EPA indicated that the Agency had issued the SIP call for the attainment demonstration under 182(c)(2)(A) only. If EPA were to add any additional requirements to the SIP call, EPA indicated that the Agency would have to re-propose the action. EPA also indicated that reliance on section 182(e)(5)("New technologies") for attainment demonstration purposes could be the subject of a future challenge if EPA were to approve a plan with such reliance. SCAQMD asked whether EPA had any particular format in mind for the 1-hour ozone attainment demonstration (e.g., as a separate chapter, or separate appendix, etc.), and EPA expressed no preference in that regard other than to present 1-hour ozone material separately from 8-hour ozone and other pollutant material where possible to allow for separate evaluation and action (if needed). In connection with the VMT offset demonstration, SCAQMD indicated they will be using EMFAC2011 and EPA indicated that the Agency had no objection to its use.

The agenda associated with this conference call is attached to this memorandum.

                          AQMD/U.S.EPA Region 9 call

                                   9/14/2012

                                    Agenda

         8-hour ozone SIP update
                 Revision, update, SIP commitments
                 Revised inventory
                 Additional requirements based on new inventory
                 Attainment demonstration

         1-hour ozone SIP
                 Required Elements
                 RFP: Applicability of 15% VOC reduction; milestone years
                 Contingency (182(e)(5))
                 Applicability of Section 182(g)(5) Economic Incentive Program?
                 Timing/format

         VMT offset demonstration
        	1-hour
        8-hour
        	2007 or 2011 EMFAC


[Federal Register Volume 82, Number 68 (Tuesday, April 11, 2017)]
[Notices]
[Pages 17424-17425]
[FR Doc No: 2017-07240]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI17-3-000]

Joel Herm; Notice of Declaration of Intention and Soliciting
Comments, Protests, and Motions To Intervene

    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No: DI17-3-000.
    c. Date Filed: March 8, 2017, and supplemented on March 20, 2017.
    d. Applicant: Joel Herm.
    e. Name of Project: Waterwood Micro Hydropower Project.
    f. Location: The proposed Waterwood Micro Hydropower Project would
be located on Landsman Kill Stream, near the Town of Rhinebeck, in
Dutchess County, New York.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b) (2012).
    h. Applicant Contact and Agent: Joel Herm, P.O. Box 224, Rhinebeck,
NY 12572, telephone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>    i. FERC Contact: Any questions on this notice should be addressed
to Jennifer Polardino,<PHONE_NUMBER>, or by email:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and motions to intervene
is: 30 days from the issuance date of this notice by the Commission.
    The Commission strongly encourages electronic filing. Please file
comments, protests, and motions to intervene using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. The first page of any
filing should include docket number DI17-3-000.
    k. Description of Project: The proposed run-of-river Waterwood
Micro Hydropower Project would consist of: (1) The existing stone and
concrete Waterwood dam on Landsman Kill Stream, a tributary of the
Hudson River; (2) a 20-inch diameter, 500-foot-long penstock, extending
from the dam to the generating unit; (3) a powerhouse containing one
Kaplan turbine generating unit having a total installed capacity of 20
kilowatts with a rated head at 13 feet and a hydraulic capacity of 36
cubic feet per second (cfs); (4) a tailrace; (5) a transmission line
connecting the generating unit to a point of interconnection with
Central Hudson Gas and Electric Corporation's power grid; and (6)
appurtenant facilities.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the project would affect the interests of
interstate or foreign commerce. The Commission also determines whether
or not the project: (1) Would be located on a navigable waterway; (2)
would occupy public lands or reservations of the United States; (3)
would utilize surplus water or water power from a government dam; or
(4) would be located on a non-navigable stream over which Congress has
Commerce Clause jurisdiction and would be constructed or enlarged after
1935.
    l. Locations of the Application: This filing may be viewed on the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp
Enter the docket number excluding the last three digits in the docket
number field to access the document. You may also regi.ster online at
http://www.ferc.gov/docs-filing/esubscription.asp to be notified via
email of new filings and issuances related to this or other pending
projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above and in the Commission's Public Reference Room located at 888
First Street NE., Room 2A, Washington, DC 20426, or by calling (202)
502-8371.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: All filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', and
``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of the
particular application to which the filing refers. A copy of any Motion
to Intervene must also be served upon each representative of the
Applicant specified in the particular application.

    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

    Dated: April 5, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-07240 Filed 4-10-17; 8:45 am]
 BILLING CODE 6717-01-P