Second Round of FAA Comments on EPA Preliminary Draft Notice of Proposed Rulemaking ( NPRM) on the Control of Air Pollution from Aircraft and Aircraft Emissions; Emissions Standards and Test Procedures GENERAL As previously stated in our first round of comments to EPA's draft NPRM to adopt ICAO CAEP 4 NOx standards of 1999, FAA strongly supports the long overdue proposal to adopt the CAEP 4 standards to 40 CFR Part 87 as they appear in the NPRM section titled Part 87  Control of Air Pollution From Aircraft and Aircraft Engines.

We appreciate the considerable changes and additions to the Draft NPRM that were taken into consideration. However, we continue to have serious concerns over EPA's approach to the NPRM preamble to adopt the CAEP 4 NOx standards. We believe that the preamble should be much more focused by simply specifying the standards; clearly and unambiguously quantifying aviation's relative contribution to pollution presently and, according to current forecasts, in the future; highlighting the credible international approach to reducing aviation emissions by which standards are established through ICAO; highlighting the importance of costs, benefits, technology, and safety in establishing standards; identifying the successful progress of the aviation industry in reducing emissions to date; and identifying the continued efforts of the international community in addressing aviation emissions in a harmonized fashion.

Limiting the NPRM to these most germane topics would keep the regulatory process focused on adoption of the current CAEP 4 standard alone and invite less controversy over what should otherwise be an easy progression in the development of U. S. aircraft emissions standards. EPA's approach to adopting the latest international standards appears to be a venue for unlimited comment on every possible aspect of aviation emissions rather than simply an adoption of the CAEP 4 NOx standards. More appropriately, much of the text currently found in the NPRM might best be drafted in a separate request for information and, with important consideration given to timing at this point, would help to expedite adoption of the CAEP 4 NOx standards before the logical U. S. deadline of December 31, 2003.

It is clear from the original substantive text, continued discussions and comments among our staffs, and addition of what appears to be even more extemporaneous text to the NPRM, that we are not likely to persuade EPA into adopting a more simplified, focused approach. Consequently, we are very reluctantly offering comments to the sections of the text to which we most strongly object, or otherwise believe require changing, and are only offering direct editorial changes to the discussion on the stakeholder process found on pages 76 through 79.

COMMENTS TO THE PREAMBLE Page 2, first full paragraph, third second sentence: " Since aircraft and aircraft engines are international commodities, there is some commercial benefit to consistency..." insert " significant" before commercial. Harmonization offers a very meaningful benefit to US manufacturers.

Page 14, first full paragraph, second sentence, and elsewhere in the NPRM: " The CAEP is responsible for discussing and recommending measures to the ICAO Council that address the environmental impact of international civil aviation." The CAEP does much more than simply discuss and recommend measures, such as researching, evaluating, and recommending measures to the ICAO Council that address the environmental impact of international civil aviation. The document still does not fully convey the importance and role of CAEP in establishing international standards.

Page 17, Environmental Need for Control: The data, as presented, is still confusing. The text should state that aviation contributes less than 2% of NOx emissions rather than "... over 1 percent of the NOx emissions..." Figures identifying a 40% increase to NOx by 2020 ( p. 18) are based on 1995 reports/ data and, we believe, there are more current sources of data for aircraft emissions that should be referenced. For example, the more recent 2001 EPA trends reports, which include updated EPA methodologies for estimating emissions, indicate that from 1999 to 2001 there was a 19% decrease in aircraft NOx emissions, a 24% decrease in CO emissions, and a 52% decrease in VOC emissions. These " actual" decreases must be identified if EPA persists in wanting to " project" increases out to 2020 based upon speculative assumptions. Again, quoting too many statistics in an unbalanced fashion is likely to give the reader an inaccurate view of the actual current contribution of aviation emissions and their comparison to other sources, and an inflated basis upon which to judge potential future increases of such emissions.

Page 19: " Recently, FAA reported that flights of commercial air carriers will increase by 18 percent from 2002 to 2010 and 45 percent from 2002 to 2020." To fully give context to the impact of the events of September 11th, earlier projections should be quoted here for comparison.

Page 55, first partial paragraph, last sentence: "... we need more time to better understand the benefits and cost of compliance with such standards..." CAEP not only looks at costs, but also the benefits of various stringency standards and this should be equally conveyed throughout the NPRM.

Page 56, the footnote on fleet structure: We have not fully reviewed the reference, however it is difficult to understand why the airlines would be incorporating RJ's if they are that much less fuel efficient than aircraft they are replacing. Could some clarification be provided on this?

Page 59, first partial paragraph, last sentence: Perhaps a more thorough discussion of the LTTG, including the fact that it makes considerations beyond CAEP 6, should be included.

Page 60, first full paragraph, first sentence: Same comment with regard to costs and benefits as made to page 55, first partial paragraph, last sentence.

Page 68, Section 3: It would be much better to open this section with an introduction of ICAO's review of production cut off dates and ask for comments in this context. This would be more consistent with the US approach and not leave ICAO as an after thought in this part of the NPRM.

Page 69, first paragraph, last three sentences: The concept of emissions averaging pertaining to the CAEP 4 NOx standard should be deleted from this NPRM. Current text already acknowledges that the concept would have little value with respect to this rulemaking. If EPA believes this could be a valid concept, then it should be presented as such for possible future consideration under the ICAO CAEP work program, and future considerations of more stringent emissions standards that may be adopted by ICAO.

EDITORIAL CHANGES NEEDED FOR THE SECTION ON THE STAKEHOLDER PROCESS, PAGES 76 79:

We suggest that the entire section on the stakeholder process, " VI Possible Future Aircraft Emissions Controls...." be edited according to the following: VI. Possible Future Aviation Emissions Reductions ( EPA/ FAA Voluntary Aviation Emissions Reduction Initiative)

There is growing interest, particularly at the state and local level, in addressing emissions from aircraft and other aviation related sources. Such interest is often related to plans for airport expansion which is occurring across the country. It is possible that other approaches may provide effective avenues to achieve additional aviation emissions reductions beyond the regulatory standards for aircraft engine certification promulgated by EPA. The Agency invites comment on the potential approach for additional reductions discussed below and any other approaches.

Concerns by state and local air agencies and environmental and public health organizations about aviation emissions led to EPA and FAA signing a memorandum of understanding ( MOU) in March 1998 agreeing to work to identify efforts that could reduce emissions. 124 Since that time FAA and EPA have jointly chaired a national stakeholder initiative whose goal is to develop a voluntary program to reduce pollutants from aircraft and other aviation sources that contribute to local and regional air pollution in the United States. The major stakeholders participating in this initiative include representatives of the aviation industry ( passenger and cargo airlines and engine manufacturers), airports, state and local air pollution control officials, environmental organizations, and NASA.

Initially, the discussions with stakeholders focused on the prospect of aircraft engine emission reduction retrofit kits, which might be applied to certain existing aircraft engines.

However, since such kits did not materialize as anticipated, the focus was expanded by the stakeholdersto identify strategies for various types of ground service equipment ( GSE) in use at airports ( e. g., baggage tugs and fuel trucks), in addition to strategies to reduce aircraft emissions.

More recently, the stakeholders agreed to attempt to reach consensus on a two step program based on an assessment of the relative timing involved to achieve further wide scale emissions reductions in ground based aviation sources compared to the aircraft fleet: Near term:

focused on GSE emissions reductions Longer term: focused on aircraft emissions reductions125 124FAA and EPA, " Agreement Between Federal Aviation Administration and Environmental Protection Agency Regarding Environmental Matters Relation to Aviation," signed on March 24, 1998 by FAA's Acting Assistant Administrator for Policy, Planning, and International Aviation, Louise Maillet, and EPA's Acting Assistant Administrator for Air and Radiation, Richard Wilson. A copy of this document can be found in Docket OAR 2002 0030, Document No. ___ __)

125A program for aircraft emissions reductions would supplement the traditional regulatory approach to engine emission standards. The stakeholders are currently discussing a framework for reaching consensus on the goals or targets for emissions reductions, timing, accountability, State Implementation Plan implications ( including general conformity), and numerous other issues that have been raised for GSE and aircraft emission reductions. If this initiative is successful, an agreement would be reached among all the stakeholders on a national voluntary aviation emissions reduction program. The mechanism that could be used to codify or enforce an eventual agreement has yet to be determined. The goal of the EPA/ FAA stakeholder initiative is to develop a program that will achieve significant national emissions reductions.

[ Some of the sentences in the above paragraph have been moved into other paragraphs.

Other sentences are simply proposed to be deleted.]

[ This final paragraph should be entirely deleted. It is not consistent with a primary driver of a national agreement, which is to substitute a nationally consistent approach for a patchwork of state/ local requirements.]


[Federal Register Volume 88, Number 67 (Friday, April 7, 2023)]
[Notices]
[Pages 20874-20875]
[FR Doc No: 2023-07391]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15300-000]

Heard County Pumped Storage Project; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On January 31, 2023, BOST1 Hydroelectric, LLC., filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of a pumped
storage hydropower project located near the City of Enon Grove, Heard
County, Georgia. The sole purpose of a preliminary permit, if issued,
is to grant the permit holder priority to file a license application
during the permit term. A preliminary permit does not authorize the
permit holder to perform any land-disturbing activities or otherwise
enter upon lands or waters owned by others without the owners' express
permission.
    The proposed Heard County Pumped Storage Project would consist of
the following: (1) a 20-foot-long, 30-foot-deep reinforced concrete
intake structure with trash racks, and a pumping station on Hilly Mill
Creek; (2) a 24-inch-diameter fill pipeline to the upper reservoir; (3)
a geotextile lined rock filled embankment forming an enclosed upper
reservoir; (4) a 66-foot-deep enclosed upper reservoir with a storage
capacity of 5,300 acre-feet; (5) a lower underground reservoir
consisting of concentric circular tunnels reaching a depth of 2,100
feet below the surface, with the total length of the tunnels being
170,000 feet; (6) a reinforced morning glory type water intake situated
within the upper reservoir with an outer diameter of 95 feet and an
inside diameter of 38 feet; (7) a 23-foot-diameter, 2,300-foot-long
granite bedrock vertical tunnel trifurcating into three 10-foot-
diameter steel lined penstocks leading to three reversible Francis pump
turbines; (8) a 460-foot-long, 80-foot-wide, 160-foot-high powerhouse,
200 feet below the lower reservoir containing the three pump turbine
units with a total installed capacity of 1,000 megawatts; (9) a
separate 60-foot-wide, 410-foot-long, 160-foot-high underground
transformer gallery near the powerhouse; and (10) a 1-mile-long, 500
kilovolt transmission line east of the proposed upper reservoir. The
lower reservoir tunneling would be accomplished using two 42.5-foot-
diameter tunnel boring machines with an access ramp of the same size
from the surface. The powerhouse would be excavated using traditional
drill and blast methods. The proposed project would have an estimated
annual generation of 2,628,000 megawatt-hours.
    Applicant Contact: Douglas Spaulding, Nelson Energy, 8441 Wayzata
Blvd., Suite 101, Golden Valley, MN 55426; phone:<PHONE_NUMBER>.
    FERC Contact: Michael Spencer; phone:<PHONE_NUMBER>, or by email
at [email protected].
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at https://ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief comments
up to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.ferc.gov/QuickComment.aspx. You must
include your name and contact information at the end of your comments.
For assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include docket
number P-15300-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's website at

https://elibrary.ferc.gov/eLibrary/search. Enter the docket number (P-
15300) in the docket number field to access the document. For
assistance, contact FERC Online Support.

    Dated: April 3, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-07391 Filed 4-6-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 12, 2009 (Volume 74, Number 154)]
[Rules and Regulations]
[Page 40521-40523]
[DOCID:fr12au09-14]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary of Transportation

49 CFR Part 89

[Docket No. OST-2008-0329]
RIN 2105-AD78

Administrative Wage Garnishment

AGENCY: Office of the Secretary of Transportation (OST), DOT.

ACTION: Final rule.

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SUMMARY: This final rule will implement the authority established under
the Debt Collection Improvement Act of 1996 (DCIA) for DOT to collect
the Department's past due indebtedness through administrative wage
garnishment. The final rule will adopt, without change, the hearing
procedures issued by the Department of the Treasury implementing
administrative wage garnishment under the DCIA. This final rule would
apply only to individuals who are not Federal employees. The final rule
also will amend regulations on procedures for the collection of claims
to conform DOT regulations to applicable provisions of the DCIA.

DATES: This rule is effective September 11, 2009.

FOR FURTHER INFORMATION CONTACT: Edward C. Ramos, Collections
Specialist, Office of the Secretary of Transportation, Department of
Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590;
(202) 366-5905. Hearing and speech-impaired persons may access this
number via TTY by calling the Federal Information Relay Service at 1-
800-877-8339.

SUPPLEMENTARY INFORMATION:

Background

    In 1996, Congress enacted the Debt Collection Improvement Act of
1996 (Pub. L. 104-134, 110 Stat. 1321-1358, approved April 26, 1996),
which amended the Debt Collection Act of 1982. Section 31001(o) of the
DCIA authorizes collection of Federal agency debt by administrative
wage garnishment (section 31001(o) is codified at 31 U.S.C. 3720D).
Wage garnishment is a legal process whereby an employer withholds
amounts from an employee's wages and pays those amounts to the
employee's creditor in satisfaction of a withholding order. The DCIA
authorizes Federal agencies to garnish up to 15% of the disposable pay
of a debtor to satisfy delinquent nontax debt owed to the United
States. Prior to the enactment of the DCIA, agencies were required to
obtain a court judgment before garnishing the wages of non-Federal
employees.
    The DCIA directed the Secretary of the Treasury to issue
implementing regulations (see 31 U.S.C. 3720D(h)) on this subject. On
May 6, 1998 (63 FR 25136), the Department of the Treasury published a
final rule implementing the statutory administrative wage garnishment
requirements at 31 CFR 285.11. Paragraph (f) of 31 CFR 285.11 provides
that ``[a]gencies shall prescribe regulations for the conduct of
administrative wage garnishment hearings consistent with this section
or shall adopt this section without change by reference.'' Under the
DCIA, the Treasury Department serves as a coordinator for Federal debt
collection through its Treasury Offset Program.
    This final rule would amend DOT's regulations at 49 CFR part 89,
subpart B to adopt 31 CFR 285.11 in its entirety. Specifically, the
final rule would establish a new 49 CFR 89.35 that would contain a
cross-reference to 31 CFR 285.11.
    On December 5, 2008, the DOT published a notice of proposed

rulemaking in the Federal Register for the public to comment, as
required. DOT received no comments from the public on this rule.

Overview of the Administrative Wage Garnishment Process

    Readers should refer to the Department of the Treasury regulation
at 31 CFR 285.11 for details regarding the administrative wage
garnishment procedures that would be adopted by this final rule. For
the convenience of readers, the following presents a very brief
overview of the rules and procedures codified at 31 CFR 285.11.
    1. Notice to debtor. At least 30 days before the agency initiates
garnishment proceedings, the agency will give the debtor written notice
informing him or her of the nature and amount of the debt, the
intention of the agency to collect the debt through deductions from
pay, and an explanation of the debtor's rights regarding the proposed
action.
    2. Rights of debtor. The agency will provide the debtor with an
opportunity to inspect and copy records related to the debt, to
establish a repayment agreement, and to receive a hearing concerning
the existence or amount of the debt and the terms of a repayment
schedule. A hearing must be held prior to the issuance of a withholding
order if the debtor's request is timely received. For hearing requests
that are not received in the specified timeframe, the agency need not
delay the issuance of a withholding order prior to conducting a
hearing. An agency may not garnish the wages of a debtor who has been
involuntarily separated from employment until that individual has been
reemployed continuously for at least 12 months. The debtor bears the
responsibility of notifying the agency of the circumstances surrounding
an involuntary separation from employment.
    3. Hearing official. The Department of the Treasury regulations
authorize the head of each agency to designate any qualified individual
as a hearing official. This final rule would provide that any hearing
required to establish DOT's right to collect a debt through
administrative wage garnishment will be conducted by a qualified
individual selected by the Secretary of Transportation. The hearing
official is required to issue a written decision no later than 60 days
after the request for a hearing is made. The hearing official's
decision is the final agency action for purposes of judicial review.
    4. Employer's responsibilities. The Treasury Department will send
to the employer of a delinquent debtor a wage garnishment order
directing that the employer pay a portion of the debtor's wages to the
Federal Government. The employer is required to certify certain payment
information about the debtor. Employers are not required to vary their
normal pay cycles in order to comply with these requirements. Employers
are prohibited from taking disciplinary actions against the debtor
because the debtor's wages are subject to administrative garnishment.
An agency may sue an employer for amounts not properly withheld from
the wages payable to the debtor.
    5. Garnishment amounts. As provided in the DCIA, no more than 15%
of the debtor's disposable pay for each pay period may be garnished.
Special rules apply to calculating the amount to be withheld from a
debtor's pay that is subject to multiple withholding orders. A debtor
may request a review by the agency of the amount being garnished under
a wage garnishment order based on materially changed circumstances,
such as disability, divorce, or catastrophic illness, which result in
financial hardship.

Rulemaking Analyses and Notices

E.O. 12866 and DOT Regulatory Policies and Procedures

    The agency has evaluated this final rule in accordance with
existing regulatory policies and procedures and has concluded that it
is a nonsignificant regulatory action under E.O. 12866, and a
nonsignificant rule under section 5(a)(4) of the DOT Regulatory
Policies and Procedures (44 FR 11034, February 26, 1979).
    The final rule is not a significant regulatory action under E.O.
12866 because it will not have an annual effect on the economy of $100
million or more or adversely affect in a material way the economy, a
sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; will not create a serious inconsistency
with an action planned or underway by another Federal agency; will not
materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; and will not raise novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles of the
Executive Order.

Regulatory Flexibility Act

    The Secretary, in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)), has reviewed and approved this final rule, and in so
doing certifies that this final rule would not have a significant
economic impact on a substantial number of small entities. Although
many small employers will be subject to the requirements of this final
rule, the requirements will not have a significant economic impact on
these entities.
    Employers of delinquent debtors must certify certain information
about the debtor such as the debtor's employment status and earnings.
This information is contained in the employer's payroll records.
Therefore, it will not take a significant amount of time or result in a
significant cost for an employer to complete the certification form.
Even if an employer is served withholding orders on several employees
over the course of a year, the cost imposed on the employer to complete
the certifications would not have a significant economic impact on an
entity. Employers are not required to vary their normal pay cycles in
order to comply with a withholding order issued pursuant to this final
rule.

Executive Order 13132 (Federalism)

    Executive Order 13132 (entitled ``Federalism'') prohibits an agency
from publishing any rule that has federalism implications if the rule
either imposes substantial direct compliance costs on State and local
governments and is not required by statute, or the rule preempts State
law, unless the agency meets the consultation and funding requirements
of section 6 of the Executive Order.
    This final rule does not have federalism implications and does not
impose substantial direct compliance costs on State and local
governments or preempt State law within the meaning of the Executive
Order.

Executive Order 13084

    This rule has been analyzed in accordance with the principles and
criteria contained in Executive Order 13084 (``Consultation and
Coordination with Indian Tribal Governments''). Because this rule would
not significantly or uniquely affect the Indian tribal communities, and
would not impose substantial direct compliance costs, the funding and
consultation requirements of the Executive Order do not apply.

Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 establishes
requirements for Federal agencies to assess the effects of their
regulatory actions on State, local, and tribal governments and the
private sector.
    This rule would not impose a Federal mandate on any State, local,
or tribal government, or on the private sector,

within the meaning of the Unfunded Mandates Reform Act of 1995.

Executive Order 12372 (Intergovernmental Review)

    The regulations implementing Executive Order 12372 regarding
intergovernmental consultation on Federal programs and activities do
not apply to this program.

Paperwork Reduction Act

    The Paperwork Reduction Act (44 U.S.C. 3501 et seq.) addresses the
collection of information by the Federal government from individuals,
small businesses and State and local government and seeks to minimize
the burdens such information collection requirements might impose. A
collection of information includes requiring answers to identical
questions posed to, or identical reporting or recordkeeping
requirements imposed on, ten or more persons, other than agencies,
instrumentalities or employees of the United States.
    This final rule contains information that would apply to
individuals and possibly small entities. However, there are no
reporting or other collection requirements associated with this final
rule, even though it relates to an employer's certification of certain
information about the debtor, such as the debtor's employment status
and earnings, which would be inquiries on a one-time basis. In any
case, comments in this area are welcomed.

National Environmental Policy Act

    In accordance with 24 CFR 50.19(c)(1) of the Department's
regulations, this final rule does not direct, provide for assistance or
loan and mortgage insurance for, or otherwise govern or regulate, real
property acquisition, disposition, leasing, rehabilitation, alteration,
demolition, or new construction, or establish, revise, or provide for
standards for construction or construction materials, manufactured
housing, or occupancy. Therefore, this final rule is categorically
excluded from the requirements of the National Environmental Policy Act
(42 U.S.C. 4321 et seq.).

Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a
Statement of Energy Effects for any ``significant energy action.'' See
66 FR 28355 (May 22, 2001). Under the Executive Order a ``significant
energy action'' is defined as any action by an agency that promulgates
or is expected to lead to the promulgation of a final rule or
regulation, including notices of inquiry, advance notices of final
rulemaking, and notices of final rulemaking: (1)(i) That is a
significant regulatory action under Executive Order 12866 or any
successor order, and (ii) is likely to have a significant adverse
effect on the supply, distribution, or use of energy; or (2) that is
designated by the Administrator of the Office of Information and
Regulatory Affairs as a significant energy action. OST has evaluated
this final rule in accordance with Executive Order 13211.
    The Department has determined that this final rule is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. Consequently, the Department has determined that this final
rule is not a ``significant energy action'' within the meaning of the
Executive Order.

Privacy Act Statement

    Anyone is able to search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc). You may review DOT's
complete Privacy Act Statement published in the Federal Register on
April 11, 2000 (Volume 65, Number 70, Pages 19477-78) or you may visit:
http://www.regulations.gov.

Regulation Identification Number

    A regulation identification number (RIN) is assigned to each
regulatory action listed in the Unified Agenda of Federal Regulations.
The Regulatory Information Service Center publishes the Unified Agenda
in April and October of each year. The RIN contained in the heading of
this document can be used to cross reference this action with the
Unified Agenda.

List of Subjects in 49 CFR Part 89

    Claims, Income taxes.

 The Final Rule

0
For the reasons set forth in the preamble, OST amends Part 89 of
chapter I, subtitle A of title 49, Code of Federal Regulations, as set
forth below:

PART 89--IMPLEMENTATION OF THE FEDERAL CLAIMS COLLECTION ACT

0
1. The authority citation for 49 CFR part 89, subpart B is revised to
read as follows:

    Authority: Public Law 89-508; Public Law 89-365, secs. 3, 10,
11, 13(b), 31 U.S.C. 3701-3720A; Public Law 98-167; Public Law 98-
369; Public Law 99-578; Public Law 101-552, 31 U.S.C. 3711(a)(2); 31
CFR 3711, 3716-3720E.

0
2. Add Sec.  89.35 to subpart B to read as follows:

Sec.  89.35  Administrative wage garnishment.

    (a) General. The Secretary may use administrative wage garnishment
for debts referred to cross-servicing at Financial Management Service,
Department of Treasury. Regulations in 31 CFR 285.11 govern the
collection of debts owed to federal agencies through administrative
wage garnishment. Whenever the Financial Management Service collects a
debt for the Secretary using administrative wage garnishment, the
statutory administrative requirements in 31 CFR 285.11 will govern.
    (b) Hearing official. Any hearing required to establish the
Secretary's right to collect a debt through administrative wage
garnishment shall be conducted by a qualified individual selected at
the discretion of the Secretary of Transportation, as specified in 31
CFR 285.11. The qualified individual may include an Administrative Law
Judge.

    Issued this 30th day of July 2009, at Washington, DC.
Ray LaHood,
Secretary of Transportation.
[FR Doc. E9-19344 Filed 8-11-09; 8:45 am]

BILLING CODE 4910-9X-P


[Federal Register Volume 83, Number 157 (Tuesday, August 14, 2018)]
[Notices]
[Pages 40293-40294]
[FR Doc No: 2018-17363]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2701]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration Food Safety, Health, and Diet Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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
September 13, 2018.

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 protected]. All
comments should be identified with the OMB control number 0910-0345.
Also include the FDA docket number found in brackets in the heading of
this document.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food Safety, Health, and Diet Survey

OMB Control Number 0910-0345--Reinstatement

    This information collection supports the above captioned FDA
survey. Under section 1003(b)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 393(b)(2)), FDA is authorized to conduct
research relating to foods and to conduct educational and public
information programs relating to the safety of the nation's food
supply. Accordingly, we are proposing a survey to measure consumers'
knowledge, attitudes, beliefs, and reported behavior about food safety
and various topics related to health, nutrition, and physical activity.
Survey questions covering hand washing, using food thermometers,
cleaning cutting boards, and properly storing food support ``Healthy
People 2030'' objectives relating to consumer food safety and help
evaluate and develop strategies and programs to encourage consumers to
adopt healthy lifestyles.
    Since late 1990, we have deployed two separate surveys to address
these topics: The ``Food Safety Survey,'' approved under OMB control
no. 0910-0345; and the ``Health and Diet Survey,'' approved under OMB
control no. 0910-0545. The surveys have provided data used in support
of Nutritional Facts labeling and have helped inform the focus and
scope of food safety educational campaigns. Because there are many
related topic areas included in the two surveys, we have decided to
combine them. The newly proposed ``FDA Food Safety, Health, and Diet
Survey'' will contain many of the same questions and topics as the
previous surveys, measuring trends in food safety, diet knowledge,
attitudes, and behaviors over time. The survey will focus on three
major themes: Eat, Shop, and Prepare. These themes and survey questions
were selected to gather information from consumers that will help FDA
monitor and evaluate its programs and policies relating to menu
labeling, use of the Nutrition Facts label, and food safety education
activities.
    The theme ``Eat'' will include questions related to eating at
restaurants, including the frequency of eating at restaurants,
awareness of menu labeling, and use of restaurant health inspection
scores. It will also include questions about consumers' overall dietary
patterns, consumption of potentially risky foods, and perceptions of
food safety risks. The theme ``Shop'' will include questions about use
of the Nutrition Facts label, claims made on the front of food
packages, and perceptions related to organic and genetically engineered
foods. Finally, the theme ``Prepare'' will include questions about food
handling practices related to cleaning hands and surfaces, separating
raw meat from ready-to-eat foods, using food thermometers, preparing
ready- and non-ready-to-eat foods, and properly chilling foods.
    The survey will be administered using two sampling and
administrative methodologies: A random-digit-dial telephone survey of
both landline and cell phones, and an addressed-based, mail push-to-web
survey. Previously, for both the ``Health and Diet Survey'' and

the ``Food Safety Survey,'' only random digit dialing sampling
techniques and telephone interviewing were used. By using both phone
and address-based survey methods we will be able to explore the effects
of survey mode and sampling frames on question responses with the goal
of potentially transitioning the survey entirely to an address-based,
mail push-to-web survey. A nationally representative sample of 2,000
adults will be selected at random to complete the telephone survey. The
addressed-based survey will seek 4,000 respondents. Additionally,
methods will be employed to see if response bias is a problem in the
survey. As noted above, participation in the survey will be voluntary.
Cognitive interviews and a pretest will be conducted prior to fielding
the survey.
    In the Federal Register of July 3, 2017 (82 FR 30871), we published
a 60-day notice requesting public comment on the proposed collection of
information for OMB control no. 0910-0345, ``Food Safety Survey.'' Two
comments were received. One discussed the importance of food safety,
and the other comment was unrelated to the information collection.
    In the Federal Register of July 18, 2017 (82 FR 32832), we
published a 60-day notice requesting public comment on the proposed
collection of information for OMB control no. 0910-0545, ``Health and
Diet Survey.'' No comments were received. Because we are proposing to
combine the surveys, we are consolidating the burden under OMB control
no. 0910-0345 and discontinuing OMB control no. 0910-0545.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener                75               1              75  0.083 (5                       6
 (phone survey).                                                                 minutes).
Cognitive interview screener                75               1              75  0.083 (5                       6
 (mail survey).                                                                  minutes).
Cognitive interview (phone                   9               1               9  1...............               9
 survey).
Cognitive interview (mail                    9               1               9  1...............               9
 survey).
Pre-test screener (phone                   100               1             100  0.0167 (1                      2
 survey).                                                                        minute).
Pre-test screener (mail                    100               1             100  0.0167 (1                      2
 survey).                                                                        minute).
Pretest (phone survey)........              40               1              40  0.25 (15                      10
                                                                                minutes).
Pretest (mail survey).........              25               1              25  0.33 (20                       9
                                                                                minutes).
Survey screener (phone survey)          20,000               1          20,000  0.0167 (1                    334
                                                                                minute).
Survey screener (mail survey).          40,000               1          40,000  0.0167 (1                    668
                                                                                minute).
Phone survey..................           2,000               1           2,000  0.25 (15                     500
                                                                                minutes).
Mail survey...................           4,000               1           4,000  0.33 (20                   1,320
                                                                                minutes).
Non-Response phone survey                  200               1             200  0.0167 (1                      3
 screener.                                                                       minute).
Non-Response mail survey                   200               1             200  0.0167 (1                      3
 screener.                                                                       minute).
Non-Response phone survey.....             100               1             100  0.167 (10                     16
                                                                                minutes).
Non-Response mail survey......             100               1             100  0.167 (10                     16
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           2,913
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We will use a cognitive interview screener with 75 individuals for
each of the phone and mail surveys to recruit prospective interview
participants for a total of 150 individuals. We estimate that it will
take a screener respondent approximately 5 minutes (0.08 hour) to
complete the cognitive interview screener, for a total of 12 hours for
both surveys. We will conduct cognitive interviews with 18
participants, 9 for each survey. We estimate that it will take a
participant approximately 1 hour to complete the interview, for a total
of 18 hours. Prior to the administration of the surveys, the Agency
plans to conduct a pretest to identify and resolve potential survey
administration problems.
    We will use a pre-test screener with 175 individuals total; we
estimate that it will take a respondent approximately 1 minute (0.0167
hour) to complete the pre-test screener, for a total of 4 hours. The
pretest will be conducted with 65 total participants (40 phone and 25
mail); we estimate that it will take a participant 15 minutes (0.25
hour) to complete the phone pretest and 20 minutes (0.33 hour) for the
mail pretest for a total of 19 hours.
    We will use a survey screener to select an eligible adult
respondent in each household to participate in the survey. A total of
60,000 individuals in the 50 states and the District of Columbia will
be screened by telephone or mail. We estimate that it will take a
respondent 1 minute (0.0167 hour) to complete the screening, for a
total of 1,002 hours for both phone and mail surveys. We estimate that
2,000 eligible adults will participant in the phone survey and 4,000
eligible adults will participate in the mail survey, the phone survey
taking 15 minutes (0.25 hour) and the mail survey taking 20 minutes
(0.33 hour), for a total of 1,820 hours.
    We will use a non-response survey screener to select an eligible
adult respondent in each household to participate in a non-response
survey. A total of 400 participants in the 50 states and the District
of Columbia will be screened by telephone or mail. We estimate that it
will take a respondent 1 minute (0.0167 hour) to complete the
screening, for a total of 6 hours for both the phone and mail surveys.
We estimate that 200 respondents total, 100 for the phone survey and
100 for the mail survey, will complete the non-response survey taking
10 minutes (0.167 hour) for a total of 32 hours. Thus, the total
estimated burden is 2,913 hours.

    Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17363 Filed 8-13-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Notices]
[Pages 28621-28623]
[FR Doc No: 2020-10256]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC20-06-000]

Commission Information Collection Activities (FERC-725A(1B));
Comment Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection FERC-725A(1B) (Certification of Electric
Reliability Organization; Procedures for Electric Reliability
Standards) and submitting the information collection to the Office of
Management and Budget (OMB) for review. Any interested person may file
comments directly with OMB and should address a copy of those comments
to the Commission as explained below.

DATES: Comments on the collection of information are due June 12, 2020.

ADDRESSES: Send written comments on FERC-725A(1B) to OMB through
www.reginfo.gov/public/do/PRAMain. Attention: Federal Energy Regulatory
Commission Desk Officer. Please identify the OMB control number (1902-
0292) in the subject line. Your comments should be sent within 30 days
of publication of this notice in the Federal Register. Please submit
copies of your comments to the Commission (identified by Docket No.
IC20-06-000) by either of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp.

     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, at Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.

Instructions

    OMB submissions: Must be formatted and filed in accordance with
submission guidelines at www.reginfo.gov/public/do/PRAMain. Using the
search function under the Currently Under Review field select Federal
Energy Regulatory Commission; click ``submit'' and select omment to the
right of the subject collection.
    FERC submissions: Must be formatted and filed in accordance with
submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support by email at
<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>and telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725A(1B), (Mandatory Reliability Standards for the Bulk
Power System).
    OMB Control No.: 1902-0292.
    Type of Request: Three-year extension of the FERC-725A(1B)
information collection requirements with no changes to the current
reporting and recordkeeping requirements.
    Abstract: The FERC-725A(1B) Under section 215 of the Federal Power
Act (FPA), the Commission proposes to approve Reliability Standards
TOP-010-1 (Real-time Reliability Monitoring and Analysis Capabilities)
submitted by North American Electric Corporation (NERC). In this order,
the Reliability Standards build on monitoring, real-time assessments
and support effective situational awareness. The Reliability Standards
accomplish this by requiring applicable entities to: (1) Provide
notification to operators of real-time monitoring alarm failures; (2)
provide operators with indications of the quality of information being
provided by their monitoring and analysis capabilities; and (3) address
deficiencies in the quality of information being provided by their
monitoring and analysis capabilities. FERC-725A(1B) address situational
awareness objectives by providing for operator awareness when key
alarming tools are not performing as intended. These collections will
improve real-time situational awareness capabilities and enhance
reliable operations by requiring reliability coordinators, transmission
operators, and balancing authorities to provide operators with an
improved awareness of system conditions analysis capabilities,
including alarm availability, so that operators may take appropriate
steps to ensure reliability. These functions include planning,
operations, data sharing, monitoring, and analysis.
    Type of Respondent: Balancing Authority (BA),Transmission
Operations (TOP) and Reliability Coordinators (RC).
    Estimate of Annual Burden: \1\ The Commission estimates the total
annual burden and cost \2\ for this information collection in the table
below.
---------------------------------------------------------------------------

    \1\ Burden is the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For further
explanation of what is included in the information collection
burden, refer to Title 5 Code of Federal Regulations 1320.3.
    \2\ Costs (for wages and benefits) are based on wage figures
from the Bureau of Labor Statistics (BLS) for May 2019 (at https://www.bls.gov/oes/current/naics2_22.htm) and benefits information (at
https://www.bls.gov/news.release/ecec.nr0.htm).

                                           FERC-725A(1B), Changes Due to TOP-010-1 in Docket No. IC20-6-000 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Annual  number
                                   Requirements &      Number of     of  responses   Total number    Average burden &     Total annual       Cost per
             Entity                    period        respondents 4        per        of responses   cost per response    burden hours &     respondent
                                                                      respondent                            5          total annual cost        ($)
                                 .................             (1)             (2)     (1) * (2) =  (4)..............  (3) * (4) = (5)..       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
BA \6\.........................  Annual reporting.              98               1              98  42 hrs.;           4,116 hrs.;             $2,696.40
                                                                                $2,696.40.         $264,247.20.
TOP \7\........................  Annual reporting.             169               1             169  40 hrs.;           6,760 hrs.;              2,568.00
                                                                                $2,568.00.         $433,992.00.
BA/TOP.........................  Annual Record                 267               1             267  2 hrs.; $75.38...  534 hrs.;                  $75.38
                                  Retention.                                                                            $20,126.46.
                                                   ------------------------------------------------                   ----------------------------------
Total Burden Hours Per Year....  .................  ..............  ..............  ..............  .................  11,410 hrs.;       ..............
                                                                                $718,365.66 per
                                                                                year, (starting
                                                                                in year 2).
--------------------------------------------------------------------------------------------------------------------------------------------------------

Averaging One-Time Burden and Responses for FERC-725A(1B), TOP-010-1 in
Docket No. IC20-6-000

--For purposes of this OMB clearance, the annual burden and record
retention of 11,410 hrs.
---------------------------------------------------------------------------

    \3\ Our estimates are based on the NERC Compliance Registry
Summary of Entities and Functions as of April 24, 2020, which
indicates there are registered as BA and TOP.
    \4\ The number of respondents is the number of entities in which
a change in burden from the current standards to the proposed
exists, not the total number of entities from the current or
proposed standards that are applicable.
    \5\ The estimated hourly costs (salary plus benefits) are based
on Bureau of Labor Statistics (BLS) information, as of May 2019 (at
http://www.bls.gov/oes/current/naics2_22.htm, with updated benefits
information for March 2019 at http://www.bls.gov/news.release/ecec.nr0.htm), for an electrical engineer (code 17-2071, $68.17/
hour), and for information and record clerks record keeper (code 43-
4199, $40.84/hour). The hourly figure for engineers is used for
reporting; the hourly figure for information and record clerks is
used for document retention.
    \6\ Balancing Authority (BA). The following Requirements and
associated measures apply to balancing authorities: Requirement R1:
A revised data specification and writing the required operating
process/operating procedure; and Requirement R2: Quality monitoring
logs and the data errors and corrective action logs.
    \7\ Transmission Operations (TOP). The following Requirements
and associated measures apply to transmission operators: Requirement
R1: A revised data specification and writing the required operating
process/operating procedure; and Requirement R3: Alarm process
monitor performance logs to maintain performance logs and corrective
action plans.
---------------------------------------------------------------------------

Summary and Response to Public Comment

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility

and clarity of the information collection; and (4) ways to minimize the
burden of the collection of information on those who are to respond,
including the use of automated collection techniques or other forms of
information technology.

    Dated: May 7, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-10256 Filed 5-12-20; 8:45 am]
BILLING CODE 6717-01-P


This study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.3800; OECD 416) for a two-generation
reproduction study in the rat.

A.3.4	Chronic Toxicity

870.4100b Chronic Toxicity – Dog

EXECUTIVE SUMMARY: In a chronic toxicity study (MRID 46800232), NOA
446510 (Mandipropamid; 96.5% w/w, Batch #: SEZ2BP007) was administered
daily in capsules to 4 beagle dogs/sex/dose for 52 weeks at doses of 0,
5, 40, or 400 mg/kg/day.

There were no mortalities and no effects of treatment on ophthalmoscopy,
hematology, urinalysis, or gross pathology.  There were no
treatment-related effects on any parameter at 5 mg/kg/day.

One 40 mg/kg/day female was slightly thin beginning at Week 6, and one
400 mg/kg/day female was slightly to moderately thin beginning at Week
-2.  Additionally at 400 mg/kg/day, two females exhibited slight to
moderate salivation during dosing (83 incidences beginning at Week 3)
and at non-dosing observations (96 occasions beginning at Week 1).
These clinical findings continued until study termination.

At 400 mg/kg/day, minor decreases of 1-12% in body weights were observed
in both sexes throughout the study.  Body weight gains for Weeks 1-13
were decreased by 23% compared to controls in the males and by 30% in
the females.  Body weight gains for the overall (Weeks 1-53) study
remained decreased at this dose in the males (decr. 15%) and females
(decr. 45%).  Additionally in the 400 mg/kg/day females, minor (<=7%
compared to controls) but consistent (43 out of 52 weeks) decreases in
food consumption were observed.

The liver was the target organ of toxicity.  At >=40 mg/kg/day, alkaline
phosphatase activity was increased throughout the study in the males
(incr. 57-174%) and females (incr. 27-273%).  These increases attained
significance (p<=0.05), except in 40 mg/kg/day females at Week 13.
Additionally in the males, alanine aminotransferase (ALT) activity was
increased throughout the study at 40 mg/kg/day (incr. 89-150%; not
significant) and 400 mg/kg/day (incr. 315-445%; p<=0.05).  Additionally
at 400 mg/kg/day, ALT was increased throughout the study in the females
(incr. 182-352%), attaining significance (p<=0.05) at Week 52.

Increases in absolute (incr. 7-15%), relative to body weight (incr.
20-27%), and adjusted for terminal body weight (incr. 16-19%) liver
weights were observed in the 400 mg/kg/day males and females, with the
adjusted liver weight in the males attaining significance (p<=0.01).

At 40 mg/kg/day, minimal increased pigment in the liver was observed in
2/4 males and 1/4 females, compared to 0/4 controls.  At 400 mg/kg/day,
the incidence of this finding increased to 3/4 males and 3/4 females,
and the severity was minimal to moderate in the males and minimal to
slight in the females.  It was stated that this pigment appeared to be
consistent with porphyrin.

The LOAEL is 40 mg/kg/day based on evidence of liver toxicity (increased
incidence and severity of microscopic pigment in the liver and increased
alkaline phosphatase activity in both sexes and increased alanine
aminotransferase activity in males).  The NOAEL is 5 mg/kg/day.

This study is classified as acceptable/guideline and satisfies the
guideline requirement (OPPTS 870.4100b, OECD 452) for a chronic oral
toxicity study in dogs.

A.3.5	Carcinogenicity

870.4200a Combined Chronic/Carcinogenicity – Rat

EXECUTIVE SUMMARY: In a combined chronic toxicity/carcinogenicity study
(MRID 46800234), NOA 446510 (Mandipropamid; 96.5% a.i.; Batch No.
SEZ2BP007) was administered in the diet to Alpk:APfSD rats (52/sex/dose)
at doses of 0, 50, 250, or 1000 ppm (equivalent to 0, 3.0/3.5,
15.2/17.6, and 61.3/69.7 mg/kg bw/day in males/females) for up to 2
years.  Additionally, 12 rats/sex/dose were treated similarly and
terminated after 1 year.

No treatment-related effects were observed on mortality, clinical signs,
neurological evaluation, food consumption, ophthalmoscopic examination,
hematology, clinical chemistry, urinalysis, or organ weights.  No
treatment-related pathological findings were noted at 12 months.

In the 1000 ppm males, decreased (p<=0.05) body weights were generally
observed during Weeks 2-15 and 67-103 (decr 1-6%).  A similar effect was
observed on cumulative body weight gain (decr 3-7%; p<=0.05).  Overall
(Weeks 1-105) body weight gain was decreased by 6% (not statistically
significant).  Food utilization was decreased during Weeks 1-4, 5-8,
9-13, and 1-13 by 5-7% (p<=0.01; except not statistically significant at
Weeks 9-13).

In the kidney of the 1000 ppm males, an increased incidence of a
roughened surface was observed (13/64 treated vs 5/64 controls).
Severity of chronic progressive nephropathy was increased, with an
increased incidence of moderate to marked severity of 53% treated vs 38%
controls.  Associated increases in the incidences of minimal to marked
renal osteodystrophia fibrosa (19% treated vs 8% controls) and minimal
to marked parathyroid hyperplasia (28% treated vs 17% controls) were
also noted.

The LOAEL is 1000 ppm (equivalent to 61.3/69.7 mg/kg/day in
males/females), based on decreased body weight gain and food utilization
and increased nephrotoxicity in the males. The NOAEL is 250 ppm
(equivalent to 15.2/17.6 in males/females).

At the doses tested, there was not a treatment-related increase in tumor
incidence when compared to controls.  Dosing was considered adequate
based on decreased body weight gain and food utilization and increased
nephrotoxicity in the males.

This study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.4300; OECD 453) for a combined chronic
toxicity/carcinogenicity study in rats.

870.4200b Carcinogenicity – Mouse

EXECUTIVE SUMMARY:  In a carcinogenicity study (MRID 46800233), NOA
446510 (Mandipropamid; 96.5% a.i.; Batch No. SEZ2BP007) was administered
in the diet to C57BL/10JfCD-1 mice (50/sex/dose) at dose levels of 0,
100, 500, or 2000 ppm (equivalent to 0/0, 10.6/13.2, 55.2/67.8, and
222.7/284.6 mg/kg bw/day in males/females) for up to 80 weeks.

No adverse treatment-related effects were observed on mortality, food
consumption, hematology (i.e., leukocyte differential), gross pathology,
or histopathology.

An increased frequency of circling behavior was observed in the females
at 500 and 2000 ppm.  However, this behavior was only slightly increased
in incidence at 2000 ppm compared to controls.  Dose-related increases
in the number of mice with their left ear being torn were observed in
both sexes at 500 and 2000 ppm.  The number of mice with the right ear
torn was minimal in incidence (<=1 mouse/dose group) and did not show a
pattern with dose.  It was stated that the animals were identified by
ear tags, and it is likely that these identification tags were placed in
the left ear.  The mice were housed together in groups and could have
removed the tags (and selectively torn the left ear) of their cage-mates
via fighting or other interactions.  However, this would not explain why
the incidence of this finding was dose-related.  The possibility that
the test substance increased fighting or some other behavior that led to
the left ear being torn cannot be ruled out.  However, because there
were no dose-related incidences in scabs or other signs of fighting and
because there were no clinical signs of neurotoxicity in this study or
in the acute or subchronic neurotoxicity studies in rats (MRID 46800240
through 46800242), the toxicological importance of this finding is
considered equivocal.

al significance (p≤0.05) throughout the study, except at Week 81 in
the males and at Week 79 in the females.  Food utilization was decreased
(p≤0.05) in the males for Weeks 9-13 (decr. 20%) and Weeks 1-13 (decr.
5%) and in the females for Weeks 1-4 (decr. 12%) and reflected the
decrease in body weights at this dose.  The decreases in body weights
were not considered to be of biological or toxicological significance.

Absolute, relative to body weight, and adjusted for initial body weight
liver weights were increased in the males at 500 ppm and in both sexes
at 2000 ppm.  These increases were significant (p<=0.05) except for
absolute weights in the 2000 ppm males (relative liver weights were not
examined statistically).  In the absence of any microscopic findings in
the liver, the relatively small increases in liver weights were not
considered adverse but were likely an adaptive response to the presence
of the test substance.

At the doses tested, there were no effects of treatment on the incidence
or time to onset of any tumor types.  Therefore, there was no evidence
of a carcinogenic effect.  Dosing was considered adequate based on
decreased body weight and body weight gain.

The LOAEL is 2000 ppm (equivalent to 223/285 mg/kg/day in
males/females), based on decreased body weight gain in both sexes and
decreased food utilization in males.  The NOAEL is 500 ppm (equivalent
to 55/68 mg/kg/day in males/females).

This study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.4200b; OECD 451) for a carcinogenicity
study in mice.

A.3.6	Mutagenicity

870.5100 Bacterial Reverse Mutation Test

 derived from the livers of male Sprague-Dawley rats induced with
phenobarbital/β-naphthoflavone.  The standard plate incorporation
method was used in all trials except for Trial 2 (+S9), where a
pre-incubation step was added.  Standard strain-specific mutagens served
as positive controls.

NOA446510 was tested up to the limit dose (5000 µg/plate).
Precipitation of the test material was observed at 2500 µg/plate and
above in Trial 1 (+/-S9) and at 1000 µg/plate and above in Trial 2
(-S9) and Trial 3 (+S9).  No precipitation was noted at any
concentration in the pre-incubation assay (Trial 2 (+S9).  No evidence
of cytotoxicity (thinning of background lawn/reduced number of
revertants) was observed in any strain in the presence or absence of S9.
 There were no treatment-related increases in the mean number of
revertants/plate in any strain.  The positive controls induced marked
increases in revertant colonies compared to controls in all strains in
the presence and absence of S9-activation.  There was no evidence of
induced mutant colonies over background.

The study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.5100; OECD 471) for in vitro
mutagenicity (bacterial reverse gene mutation) data.

870.5300 In Vitro Mammalian Cell Gene Mutation Test

EXECUTIVE SUMMARY: In three independent trials of a mammalian cell gene
mutation assay at the TK +/- locus (MRID 46800236), L5178Y mouse
lymphoma cells cultured in vitro were exposed to NOA446510
(Mandipropamid; 96.5% a.i., Batch # SEZ2BP007) in DMSO at concentrations
of 0, 257, 515, 1030, 2060, or 4119 µg/mL (Trials 1 and 2, +/-S9) or 0,
1, 10, 50, 100, 250, or 500 µg/mL (Trial 3, +/-S9) for 4 hours.  The S9
fraction was derived from the livers of male Sprague-Dawley rats induced
with phenobarbital and β-naphthoflavone.  Ethylmethane-sulphonate (EMS)
and Benzo(α)pyrene (BP) served as positive controls in the absence and
presence of S9, respectively.

NOA446510 was tested up to the limit dose (4119 (g/mL, approximately 10
mM).  Cytotoxicity (decreased mean relative survival) was observed at
all doses in the presence and absence of S9 in Trials 1 and 2.  No
statistically significant (p≤0.05) or biologically relevant increases
in mutant frequency were observed in the absence of S9.  However, in the
presence of S9, statistically significant increases (p≤ 0.05) in
mutant frequency were noted at 2060 g/mL in Trial 1 and 1030 g/mL
in Trial 2.  These findings were less than twice the negative control
values and were not dose-dependent; thus the findings were not
considered biologically significant or treatment related.  The positive
controls induced the appropriate response both in the presence and
absence of S9.  There was no evidence of induced mutant colonies over
background in the presence or absence of S9-activation.

The study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.5300, OECD 476) for in vitro
mutagenicity (mammalian forward gene mutation) data.

870.5375 In Vitro Mammalian Chromosome Aberration Test

EXECUTIVE SUMMARY: In two independent trials of a mammalian cell
cytogenetics assay (chromosome aberration; MRID 46800237), lymphocyte
cultures were prepared from human peripheral blood and exposed to
NOA446510 (Mandipropamid; 96.5% a.i., Batch # SEZ2BP007) in DMSO at
concentrations of 0, 10, 50, 100, 250, 500, 1000, 2000, 3000, or 4119
µg/mL (+/-S9) for 3 hours followed by a 17 hour recovery period (Trial
1); 0, 1, 2.5, 5, 10, 25, 50, 100, or 250 µg/mL for 3 hours with a 17
hour recovery period (+S9, Trial 2); or 0, 1, 2.5, 5, 10, 25, 50, 100,
or 250 µg/mL for 20 hours with no recovery period (-S9, Trial 2).

NOA446510 was tested up to cytotoxic concentrations.  Excessive
cytotoxicity was observed at 250 µg/mL and above (+/-S9, Trial 1), 100
µg/mL and above (+S9, Trial 2), and 50 µg/mL and above (-S9, Trial 2).
 Therefore, the following concentrations were selected for evaluation of
chromosomal aberrations: (i) 10, 50, and 100 µg/mL (+/-S9, Trial 1);
(ii) 2.5, 10, and 25 µg/mL (-S9, Trial 2); and (iii) 5, 25, and 50
µg/mL (+S9, Trial 2).  No significant increases in the mean percentage
of aberrant cells were observed in either trial in the presence or
absence of S9.  The positive controls induced increases (p<0.001) in the
number of aberrant cells in the presence and absence of S9 in both
trials.  There was no evidence of chromosome aberrations induced over
background in the presence or absence of S9-activation.

This study is classified as acceptable/guideline and satisfies the
Guideline requirement (OPPTS 870.5375, OECD 473) for in vitro
mutagenicity (chromosome aberration) data.

870.5395 Bacterial Mutation Assay

EXECUTIVE SUMMARY: In a bone marrow micronucleus assay (MRID 46800238),
6-7 week old, male Wistar rats (5/dose/harvest time) were treated once
via gavage (10 mL/kg) with NOA446510 (Mandipropamid; 96.5% a.i., Batch #
SEZ2BP007) in aqueous 0.5% methylcellulose at doses of 0 or 2000 mg/kg
(limit dose).  Bone marrow cells were harvested at 24 and 48 hours after
dosing.

NOA446510 was tested at the limit dose (2000 mg/kg).  No
compound-related mortalities or clinical signs of toxicity were
observed.  A small decrease (p<0.05) in the percentage of polychromatic
erythrocytes (PCE) was observed at 48 hours post-dosing, indicating that
NOA446510 was slightly toxic to the bone marrow.  No treatment-related
increases in the micronucleated polychromatic erythrocyte (MPCE)
frequency were observed in the treated animals at either sacrifice time
compared to controls.  The positive control induced the appropriate
response.

This study is classified as acceptable/guideline and satisfies the
guideline requirement for Test Guideline OPPTS 870.5395; OECD 474 for in
vivo cytogenetic mutagenicity data.

870.5550 Unscheduled DNA Synthesis

EXECUTIVE SUMMARY: In an in vivo/in vitro unscheduled DNA synthesis
assay (MRID 46800239), rat hepatocyte cultures were prepared from 2-3
male Wistar rats/dose that were orally dosed (gavage, 10 mL/kg) once
with NOA446510 (Mandipropamid; 96.5% a.i., Batch # SEZ2BP007) in 0.5%
carboxymethylcellulose at doses of 0 or 2000 mg/kg.  Hepatocytes were
harvested at 2 or 16 hours post-dosing.

NOA446510 was tested up to the limit dose (2000 mg/kg).  The net nuclear
grain (NNG) counts in the treated animals (–4.8 to –4.7) were well
below the threshold of 0 or more NNG required for a positive response,
and the mean percent of cells in repair (>5 NNG/cell) in the treated
animals was only 1% in both trials.  The positive controls induced the
appropriate response in both trials.  There was no evidence that
unscheduled DNA synthesis, as determined by radioactive tracer
procedures [nuclear silver grain counts] was induced.

The study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.5550; OECD 482/486) for other
genotoxic mutagenicity data.

A.3.7	Neurotoxicity

870.6200a Acute Neurotoxicity Screening Battery

EXECUTIVE SUMMARY: In an acute neurotoxicity study (MRIDs 46800242 and
46800241), groups of fasted, >=42-day old Alpk:APfSD (Wistar-derived)
rats (10/sex/dose) were given a single gavage dose (10 mL/kg) of NOA
446510 (Mandipropamid; 96.5% a.i., Batch No. SEZ2BP007) in 0.5%
carboxymethylcellulose at doses of 0, 200, 600, or 2000 mg/kg (limit
dose) and were sacrificed on Day 15.  Functional observational battery
(FOB) and motor activity testing were performed on all animals during
pre-exposure, Days 1 (at 2-4 hours post-dosing), 8, and 15.  At study
termination, 5 animals/sex/dose group were anesthetized and perfused in
situ for neuropathological examination.  The brain and peripheral
nervous system tissues collected from the perfused animals in the
control and 2000 mg/kg/day groups were subjected to histopathological
evaluation.

No treatment-related effects were observed on mortality, clinical signs,
body weight, body weight gains, food consumption, functional
observational battery parameters, motor activity, or neuropathology.

The LOAEL was not observed.  The NOAEL is 2000 mg/kg (limit dose).

This neurotoxicity study is classified as acceptable/guideline and
satisfies the guideline requirement for an acute neurotoxicity study in
rats (870.6200a; OECD 424).

870.6200b Chronic Neurotoxicity Screening Battery

EXECUTIVE SUMMARY: In a subchronic neurotoxicity study (MRID 46800240)
NOA 446510 (Mandipropamid; 96.5% a.i., Batch No. SEZ2BP007) was
administered in the diet to 12 Alpk:APfSD rats/sex/group at dose levels
of 0, 100, 500, or 2500 ppm (equivalent to 0/0, 7.4/8.4, 37.3/41.0, and
192.5/206.7 mg/kg bw/day in males/females) for at least 90 consecutive
days.  Neurobehavioral assessment (functional observational battery
[FOB] and motor activity testing) was performed in 12 rats/sex/group at
Weeks -1, 2, 5, 9, and 14.  At study termination, 5 rats/sex/group were
anesthetized and perfused in situ for neuropathological examination.
The tissues from the perfused animals in the control and 2500 ppm groups
were subjected to histopathological evaluation of brain and peripheral
nervous system tissues.

No adverse, treatment-related effects were observed on mortality,
clinical signs, food consumption, functional observational battery
parameters, motor activity, brain weights, or neuropathology.

In the 2500 ppm males, body weights were decreased (not statistically
significant [NS]) by 3% initially at Week 1 and 2-7% throughout the
study, and decreased (p<=0.05) cumulative body weight was observed from
Week 10 until termination (decr 10-11%).  Decreased (p<=0.05) food
utilization was noted during Weeks 5-8 (decr 16%).  Decreases (NS) were
also observed during Weeks 1-4 (decr 6%) and 9-13 (decr 12%), leading to
a decreased (NS) overall (Weeks 1-13) food utilization (decr 9%).  The
effect on food utilization was of a similar magnitude to that observed
on body weight and body weight gain.  There were no effects on body
weight, body weight gain, food consumption or food utilization in
females.

Slight increases (p<=0.05) of 13-26% were observed in liver weight at
2500 ppm in the following groups: female adjusted liver weight
post-perfusion, and absolute and adjusted liver weights (without
perfusion) in both sexes.  The effect on the liver was considered
equivocal in the absence of any other evidence supporting
hepatotoxicity.

No neurological effects were observed at any dose in either sex.

The LOAEL is 2500 ppm (equivalent to 192/207 mg/kg bw/day in
males/females) based on slightly decreased body weight, body weight
gain, and food utilization in males.  The NOAEL is 500 ppm (equivalent
to 37/41 mg/kg bw/day in males/females).

The study is classified as acceptable/guideline and satisfies the
guideline requirement (OPPTS 870.6200b) for a subchronic neurotoxicity
study in rats.

A.3.8	Metabolism

Metabolism – Rat

EXECUTIVE SUMMARY: In rat metabolism studies (MRIDs 46800243, 46800244,
46800245, and 46800246), [14C]-NOA 446510 (Mandipropamid; 95.2-96.8%
radiochemical purity) in 1% w/v aqueous carboxymethylcellulose was
administered to Alpk:APfSD (Wistar-derived) rats/sex/dose as a single
oral gavage dose at 3 or 300 mg/kg body weight.  Group size was 3-4
rats/sex/dose (per time interval, where applicable).  Results were
evaluated following treatment with [methoxyphenyl-U-14C]-NOA 446510 and
[chlorophenyl-U-14C]- NOA 446510.  Bile duct-cannulation and tissue time
course studies were also performed.

Absorption was 67-74% of dose in the animals treated at 3 mg/kg and
30-45% of dose in the animals treated at 300 mg/kg, based on the sum of
the radioactive residues found 48 hours after dose administration in the
rat urine, bile, and carcass and in the cage wash.  There was no clear
difference in compound absorption between the sexes.  Absorption was
decreased at the high dose, suggesting a saturation of the absorption
kinetics.  The Tmax in blood at the low dose was 8.5 hours in males and
4.5 hours in females and at the high dose was 24 hours in males and 10
hours in females.  These data suggest that the rate of absorption is
greater in females while the extent of the absorption is similar between
the sexes, and that the extent and rate of absorption is greater in the
low dose than the high dose.

Total recoveries at 168 hours post-dose were 88-99% of the administered
dose.  The administered dose was mostly eliminated within 48 hours.
Excluding the 3 mg/kg females, most of the dose was excreted in the
feces regardless of the radiolabel position.  In the 3 mg/kg females,
the amount excreted in the feces was similar to that excreted in the
urine.  Regardless of sex, radiolabel position, or dose, the amount of
administered radioactivity isolated from the exhaled air was 0.16% dose
or less, and the amount of the dose remaining in the body after 168
hours was <1.1% dose.  In the multiple dose study (methoxyphenyl label
only), the excretion profile on Day 2 after a single dose was similar to
that on Day 15 after 14 doses, indicating that pre-exposure did not
influence the excretion profile.  Elimination after 48 hours in the bile
was high at 3 mg/kg (55-73% dose), but was only 22-28% dose at 300 mg/kg
(which had corresponding increases of residues found in the feces of
males and urine of females).

The liver had the highest concentration of radioactivity at the initial
measurement and all following measurements.  At 8 hours post-dose,
concentrations were 0.64-1.25 µg eq./g (0.89 µg eq./g on Day 4 in the
multiple dose study) at 3 mg/kg and 27-46 µg eq./g at 300 mg/kg;
concentrations in males were approximately double those in females.  The
second highest levels were usually found in kidneys.  More radioactivity
was isolated in the plasma than whole blood.  Thus, the profile of
tissue distribution was generally similar regardless of dose, radiolabel
position, or sex; however, there were quantitative differences.  Tissue
concentrations did not increase proportionally with dose.  A 100-fold
increase in the dose resulted in a 17-56 fold increase in concentrations
in the liver.  Results from the multiple dose study indicated that
bioaccumulation did not occur in any sampled tissue.  Half-life values
for the elimination of radioactivity from the blood were 18.4-20.2 hours
at 3 mg/kg and 24.8-32.7 hours at 300 mg/kg.

Identified compounds accounted for 65.7-93.5% of the administered dose
in each group; however 6-14% of the administered dose was unaccounted
for in the rats after 168 hours of sample collection.  Differences in
the metabolite
profi敬眠牥潦湵慢敳湯猠硥潤敳湡慲楤汯
扡汥瀠獯瑩潩獡搠獥牣扩摥戠汥睯മ

Parent and the following metabolites were present at ≥5% of the
administered dose in animals treated at 3 and/or 300 mg/kg: NOA 458422,
NOA 458422 glucuronide, SYN 534133, and CGA 380778.  The quantity of
each metabolite isolated in males and females at 3 mg/kg after sampling
for 168 hours differed.  The amount of NOA 458422 glucuronide in females
was almost 3-fold more than in males, while lesser amounts of parent and
NOA 458422 were isolated in females.  Increasing the dose resulted in
increasing amounts of radioactivity isolated as parent.  In the animals
treated with [chlorophenyl-U-14C]-NOA 446510, only the parent was
isolated at >5% dose but other compounds were also isolated in animals
treated with [methoxyphenyl-U-14C]-NOA 446510.  Thus, there were
differences in the metabolite profile due to sex, dose, and radiolabel
position.  Each isolated unknown accounted for <5% dose.  The Sponsor
stated that repeated dosing had no effect on metabolism in the male
(only sex tested) with similar metabolic profiles obtained in samples
taken 24 hours after the first and final dose of a 14-day repeat dose
study; however, data were not reported.  The major metabolic
transformations involve loss of one or both of the molecule’s
propargyl groups followed by glucuronidation and O-demethylation.

This metabolism study in the rat is classified acceptable/guideline and
satisfies the guideline requirement for a metabolism study [OPPTS
870.7485, OECD 417] in rats.

Dermal Absorption – Rat

EXECUTIVE SUMMARY:  In a dermal penetration study (MRID 46800248),
[Ethyl-1-14C]-NOA 446510 (Mandipropamide; >97.9% radiochemical purity;
Batch No. ILA-163.6A-1) was applied to the skin (10 cm2) of Alpk:APfSD
rats (4 males for each time point at each dose level). Nominal doses
were 0.00152, 0.0076, or 2.54 mg/cm2 skin, with water and/or A12946B
commercial formulation blank serving as the vehicle.  A12946B is a
commercial formulation 250 g/L suspension concentrate containing 23.7%
(w/w) NOA 446510.  The highest dose mimicked a formulation concentrate,
and was included to assess exposure to mixer/loaders.  The lower doses
were aqueous dilutions representing typical in-use spray strength
dilutions of 1/333 and 1/1667 v/v.  The exposure duration was 6 hours,
after which 4 males for each dose level were sacrificed.  The remaining
were sacrificed at 24, 72, or 120 hours post-application (4
males/dose/time interval).

Recovery of the applied dose (mass balance) was 96-112%.  Minimal
absorption, based on the sum of residues in urine, feces, cage wash,
gastrointestinal tract with contents, residual carcass, and blood, was
observed (<0.17 to 3.44% of applied dose).  The majority of the
administered dose was recovered from the 6-hour skin wash (91-105%).
0.03-0.47% of the applied dose was retained at the application site, and
0.02-0.77% dose was found in the stratum corneum.

The greatest amount of absorption was noted in the 1/1667 aqueous
dilution 114 hours after the 6 hour exposure interval.  At this time
3.44% of the applied dose was absorbed.  The amount available for
absorption in the skin at the application site was less than the LOD in
all 4 animals (<0.11%) with an additional 0.53% isolated in the stratum
corneum.

This study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.7600; OECD none) for a dermal
penetration study in rats.

Appendix B:  Metabolism Assessment  TC \l1 "Appendix B:  Metabolism
Assessment

APPENDIX B.	Chemical Names and Structures of Mandipropamid and
Metabolites.

Common name/code

Matrix

(percentage, if over 10%)	Chemical name	Chemical structure

Mandipropamid/

NOA 446510 (parent)

Goat milk, fat (77.4%) & liver;

Grape fruit (80.2%,0-DAT) & leaves (76.1%,0-DAT );

Lettuce (93.5% 3-DAT);

Potato tuber & leaves (60.6%, 7-DAT);

Tomato fruit (80.4, 0-DAT) & leaves (787.4%, 14-DAT); and

Rotated lettuce(14.2%, 29-Day PBI), radish roots(29.8%, 29-Day PBI) and
tops (13.8%, 58-Day PBI), and wheat forage (12.1%, 58-Day PBI), grain &
straw.

Rat (79.0%.)	benzeneacetamide,
4-chloro-N-[2-[3-metho祸㐭⠭ⴲ牰灯湹汹硯⥹

phenyl]ethyl]-α-(2-propynyloxy)

NOA 458422

Goat kidney(17.7%) & liver;

Grape fruit & leaves;

Lettuce;

Potato leaves;

Tomato fruit & leaves; and

Rat (29.2%).
2-(4-chlorophenyl)-N-[2-(4-hydroxy-3-methoxy-phenyl)-ethyl]-2-prop-2-yny
loxy-acetamide

NOA 458422 glucuron

Rat (46.1%).

	Glucuron conjugate of
2-(4-chlorophenyl)-N-[2-(4-hydroxy-3-methoxy-phenyl)-ethyl]-2-prop-2-yny
loxy-acetamide

                       Not available

CGA 380778

Goat kidney & liver;

Grape fruit & leaves;

Lettuce;

Potato leaves;

Tomato fruit & leaves; and

Rotated lettuce, radish roots and tops, and wheat forage & straw.

Rat.
2-(4-chlorophenyl)-2-hydroxy-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-et
hyl]-acetamide

CGA 380775

Goat kidney & liver;

Grape fruit & leaves;

Lettuce;

Potato tuber 2 & leaves; and

Tomato fruit & leaves.
2-(4-chlorophenyl)-2-hydroxy-N-[2-(4-hydroxy-3-methoxy-phenyl)-ethyl]-ac
etamide

CGA 155705

Grape fruit & leaves; and

Potato tuber.	4-chlorobenzoic acid

SYN 500003

Potato tuber (12.7%, 7-DAT).	(4-chlorophenyl)-prop-2-ynyloxy-acetic acid

SYN 505503

Goat kidney & liver.

 Rat.
2-(4-chlorophenyl)-N-[2-(3,4-dihydroxy-phenyl)-ethyl]-2-prop-2-ynyloxy-a
cetamide

SYN 505503 glucuron

Rat.	Glucuron conjugate of
2-(4-chlorophenyl)-N-[2-(3,4-dihydroxy-phenyl)-ethyl]-2-prop-2-ynyloxy-a
cetamide

                     Not available

SYN 505504

Potato tuber. 2.
2-(4-chlorophenyl)-N-[2-(3,4-dihydroxy-phenyl)-ethyl]-2-hydroxy-acetamid
e

SYN 505504  glucuron

Rat.

	Glucuron conjugate of
2-(4-chlorophenyl)-N-[2-(3,4-dihydroxy-phenyl)-ethyl]-2-hydroxy-acetamid
e

                      Not available

SYN 508793; malonyl-O-glycoside of NOA 458422

Tomato fruit & leaves.	malonyl-O-glycoside of NOA 458422

SYN 508792;

O-glycoside of NOA 458422

Grape fruit & leaves; and

Tomato fruit & leaves.	O-glycoside of NOA 458422

SYN 518495

Goat kidney & liver.

	2-(4-chlorophenyl)-2-hydroxy-N-[2-(3-hydroxy-4-prop-2-ynyloxy-phenyl)-e
thyl]-acetamide

SYN 521195

Goat kidney & liver;

Grape fruit;

Lettuce; and

Potato tuber 2.
2-(4-chlorophenyl)-N-[2-(3-hydroxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide

SYN 524193

Grape fruit & leaves.

	(4-{2-[2-(chlorophenyl)-2-prop-2-ynyloxy-acetylamino]-ethyl}-2-methoxy-
phenoxy)-acetic acid

SYN 524194

Grape fruit & leaves.
{(4-chlorophenyl)-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethylcarbamoyl]
-methoxy}-acetic acid

SYN 524196

Grape fruit & leaves.	4-chlorobenzoic acid carboxymethyl ester

SYN 524197

Grape fruit & leaves.
3-[2-(4-chlorophenyl)-2-prop-2-ynyloxy-acetylamino]-propionic acid

SYN 524198

Grape fruit & leaves.

	3-[2-(4-chlorophenyl)-2-hydroxy-acetylamino]-propionic acid

SYN 524195

Grape fruit & leaves.	2-(4-chlorophenyl)-2-hydroxy-acetamide

SYN 524199

Grape fruit & leaves; and

Potato tuber.	(4-chlorophenyl)-(3,4,5-trihydroxy-6-h
ydroxy-methyl-tetrahydropyran-2-yloxy)- acetic acid

SYN 524200

Grape fruit & leaves.
2-(4-chlorobenzyloxy)-6-(3,4,5-trihydroxy-6-methyl-tetrahydro-pyran-2-yl
oxymethyl)-tetrahydro-pyran-3,4,5-triol

SYN 524201

Grape fruit & leaves.	4-chlorobenzoic acid
3,4,5-trihydroxy-6-(3,4,5-trihydroxy-6-methyl-tetrahydro-pyran-2-yloxyme
thyl)-tetrahydro-pyran-2-yl ester

NOA 458422

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2-(4-chlorophenyl)-N-[2-(4-hydroxy-3-methoxy-phenyl)-ethyl]-2-prop-2-yny
loxy-acetamide

NOA 459119

Tomato fruit & leaves.	(4-chlorophenyl)-hydroxy-acetic acid

SYN 504851

Water (29%, aerobic aquatic metabolism study).

	Allyloxy-(4-chloro-phenyl)-acetic acid

SYN 534133

Rat (10%).

	Glucuron conjugate of CGA 380775

1 Detected at <0.01 ppm in all rotated crops except wheat straw.

2 Only identified at trace levels in potato peel with LC/MS/MS analysis.

Appendix C:  Tolerance Assessment Summary and Table TC \l1 "Appendix C:
 Tolerance Reassessment Summary and Table

Appendix C. 	Tolerance Summary for Mandipropamid.

Commodity	Proposed

Tolerance (ppm)	Recommended

Tolerance (ppm)	Comments; Correct Commodity Definition

Proposed Tolerances

Brassica, Head and Stem, Subgroup 5A	3	3	The representative commodities
of Subgroup 5A are broccoli (or cauliflower) and cabbage.  Because the
cabbage (with wrapper) field trials yielded higher residue than the
broccoli, the cabbage field trials were entered into the NAFTA tolerance
spreadsheet for tolerance calculations.

[Brassica, head and stem, subgroup 5A]

Brassica, Leafy Greens, Subgroup 5B	30	25	The residue data for mustard
greens, the representative commodity of Subgroup 5B, were entered into
the NAFTA tolerance spreadsheet for tolerance calculations.

[Brassica leafy greens, subgroup 5B]

Vegetables, Cucurbit, Group 9	0.30	0.6	The representative commodities of
crop group 09 are cantaloupe, summer squash, and cucumber.  The residue
data for cantaloupe and summer squash were separately entered into the
NAFTA tolerance spreadsheet for tolerance calculations.  The data for
cucumber were not entered into the NAFTA tolerance spreadsheet because
greater than 15% of the reported residues were below the LOQ of 0.01
ppm.  If individual tolerances were to be established, the recommended
tolerances would be 0.60 ppm for cantaloupe and 0.15 ppm for summer
squash.  Since these individual values are reasonably consistent and do
not differ by a factor of 5x, HED recommends that the highest value of
0.60 ppm be used to establish a tolerance for cucurbit vegetables.

[Vegetable, cucurbit, group 9]

Vegetables, Leafy, except Brassica, Group 4	15	20	The residue data for
leaf lettuce, head lettuce, celery, and spinach, the representative
commodities of Crop Group 4,were separately entered into the NAFTA
tolerance spreadsheet for tolerance calculations.  If individual
tolerances were to be established, the recommended tolerances would be
12  ppm for leaf lettuce, 17 ppm for head lettuce, 20 ppm for celery,
and 15 ppm for spinach.  Since these individual values are reasonably
consistent and do not differ by a factor of 5x, HED recommends that the
highest value of 20 ppm be used to establish a tolerance for Vegetables,
leafy except Brassica, Group 4.

[Vegetable ,leafy,except Brassica, group 4]

Vegetables, Fruiting, Group 8	1	1.0	The residue data for bell pepper,
non-bell pepper, and tomato, the representative commodities of Crop
Group 8 were separately entered into the NAFTA tolerance spreadsheet for
tolerance calculations.  If individual tolerances were to be
established, the recommended tolerances would be 0.60 ppm for bell
pepper, 1.0 ppm for non-bell pepper, and 0.25 ppm for tomatoes.  Since
these individual values are reasonably consistent and do not differ by a
factor of 5x, HED recommends that the highest value of 1.0 ppm be used
to establish a tolerance for Fruiting Vegetables.

[Vegetable, fruiting, group 8]

Vegetables, Tuberous and Corm, Subgroup 1C	0.01	0.01	Residues were below
the method LOQ (<0.01 ppm) in/on all samples treated at 1x.

[Vegetable, tuberous and corm, subgroup 1C]

Grapes	2	1.4	The residue data for grapes were entered into the NAFTA
tolerance spreadsheet for tolerance calculations.

[Grape]

Grapes, raisins	4	3.0	The maximum expected residue in raisin resulting
from the proposed use is 3.0 ppm which was calculated by multiplying the
HAFT of 0.67 ppm by the average concentration factor of 4.5x.

[Grape, raisin]

Onion, dry bulb	0.05	0.05	The maximum residues in/on dry bulb onions
treated at 1x were 0.04 ppm.

Onion, green	4	4.0	Field trial data for green onions were entered into
the NAFTA tolerance spreadsheet for tolerance calculations.

Tomato Paste	1.3 	Remove	The maximum expected residue in tomato paste
and puree resulting from the proposed use will be covered by the
recommended tolerance for crop group 8.

Tolerances That Need to be Proposed

Okra	None	1.0	Okra is listed in the proposed label as a member of the
fruiting vegetables.  The ChemSAC (meeting of 10/18/06) has recommended
the inclusion of okra in crop group 8 (vegetable, fruiting).  However, a
separate tolerance for okra should be listed in the appropriate section
of the CFR entry until the new crop group regulation is published.

Potato, wet peel	None	0.03	The maximum expected residue in potato wet
peel resulting from the proposed use is 0.03 ppm which was calculated by
multiplying the HAFT of <0.01 ppm by the observed concentration factor
of >3x.

Appendix D:  Review of Human Research TC \l1 " Appendix D:  Review of
Human Research

"The PHED Task Force, 1995. The Pesticide Handlers Exposure Database,
Version 1.1. Electronic Database. Task Force members Health Canada, U.
S. Environmental Protection Agency, and the National Agricultural
Chemicals Association, released February, 1995."

Appendix E: Other Toxicity Studies TC \l1 " Appendix E:  Mechanistic
Studies

In addition to the toxicology guideline studies, the Registrant also
submitted, at a later date, 14 other studies.  There were two Ames
mutagenic assays (SYN500003 metabolite and SYN545038 impurity), single
dose and 14-day repeated dose studies with propargyl alcohol, an oral
LD50 rat study with SYN500003 metabolite, and the following studies
conducted with mandipropamid: a metabolism study in dogs, acute
high-dose studies in rats and mice, cell proliferation studies in rats
and mice, a 28-day oral gavage study in male rats, an oral
gavage/dietary/intravenous radioactive study in mice, a radioactive in
vivo/in vitro rat liver study, and a radioactive investigative
metabolism study in rats. These studies were considered when writing
this risk assessment; however, a detailed review of these studies is
found in a separate document (Alan Levy; Sept 12, 2007; D343579).

Mandipropamid	Human Health Risk Assessment	D340784/D341460

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DRAFT Confidential, Internal, and Deliberative Material

Mandipropamid	Risk Assessment Document	Barcode: D340784

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